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string(102) "Predictors of Placebo Response in Randomized Controlled Trials of Biologic DMARDs for RA, PsA, and SpA"
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string(742) "Many patients participating in clinical trials for rheumatic diseases show meaningful improvement even when receiving placebo plus standard care. This phenomenon complicates the interpretation of treatment effects but remains poorly understood. This project will analyze individual participant data from multiple randomized trials of biologic drugs in rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis to identify characteristics that predict response to placebo. By examining demographic, clinical, and psychosocial factors, we aim to clarify why some patients improve without active treatment. Understanding these mechanisms may improve trial design, refine patient selection, and offer new insights into disease variability."
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string(38) "University of Campania "L. Vanvitelli""
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string(31) "francesco.ciccia@unicampania.it"
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["country"]=>
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string(1603) "Background: Randomized controlled trials (RCTs) of biologic antirheumatic drugs (bDMARDs) in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and spondyloarthritis (SpA)consistently report significant improvement in a proportion of patients randomized to placebo, the causes of which are poorly investigated. Objective: To identify predictors of placebo response in phase III placebo‑controlled RCTs of bDMARDs in RA, PsA, and SpA, and to characterize patterns of early and sustained placebo responsiveness. Study Design: Analysis of participant-level data from randomized, double-blind, placebo-controlled phase II and III trials of bDMARDs. Hierarchical and stratified models will be used to account for between-trial/disease/drug heterogeneity. Participants: Adult patients with RA, PsA, or SpA randomized to placebo plus background standard of care, with available baseline characteristics and prespecified efficacy endpoints. Primary and Secondary Outcome Measures: 1) Achievement of disease‑specific, trial‑defined clinical improvement at the primary endpoint. 2) Continuous change in disease activity indices, patient‑reported outcomes including pain and global assessment, and characterization of early versus sustained placebo response trajectories. Statistical Analysis: Multivariable logistic and mixed‑effects regression models will be used to identify independent predictors of placebo response. Penalized regression and machine‑learning approaches will explore non‑linear associations. Model robustness will be assessed using cross‑validation and sensitivity analyses."
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string(3191) "Placebo response is a clinically relevant phenomenon in randomized controlled trials (RCTs) of inflammatory rheumatic diseases. Across phase II and III trials of biologic disease-modifying antirheumatic drugs (bDMARDs) in RA, PsA, and SpA [1, 2, 3], a substantial proportion of patients randomized to placebo achieve clinically meaningful and sustained responses, contributing to variability in observed treatment effects across trials [4, 5, 6, 7]. From a drug development and regulatory perspective, high and variable placebo response rates represent a major source of statistical and interpretative uncertainty, as they reduce assay sensitivity, inflate required sample sizes, and may obscure true differences between investigational products [8]. This is a relevant issue in rheumatology, where composite endpoints incorporate objective inflammatory markers and patient-reported components such as pain, fatigue, and global assessment, which are intrinsically sensitive to context and expectancies. As a result, trials evaluating similar interventions in comparable populations may yield different apparent efficacy profiles, driven in part by differences in placebo responsiveness rather than pharmacologic effect. Despite its importance, placebo response is often treated as statistical noise rather than as a clinically and methodologically meaningful phenomenon. Existing literature largely relies on trial-level summaries or post-hoc subgroup analyses, which are limited by ecological bias and inability to disentangle patient-level predictors. Moreover, most studies focus on a single disease or individual trial, limiting generalizability and preventing systematic evaluation of shared versus disease-specific determinants of placebo response. The implication of this evaluation go beyond methodological refinement. From a clinical standpoint, placebo responsiveness may reflect underlying disease characteristics such as lower inflammatory burden, symptom-inflammation discordance, or heightened sensitivity to contextual care effects [9]. From a trial design perspective, identifying predictors of placebo response could inform enrichment or stratification strategies, improve power calculations, and support more efficient and ethical study designs by reducing unnecessary exposure to inactive treatments. The availability of individual participant-level data (IPD) from multiple placebo-controlled RCTs through the YODA Project provides a unique opportunity to address this knowledge gap, by allowing direct modeling of patient-level predictors while explicitly accounting for between-trial heterogeneity in design, population, disease indication, and outcome definition. By systematically identifying and validating predictors of placebo response across RA, PsA, and SpA trial populations, this study seeks to reframe placebo response from an unavoidable nuisance to a measurable and partially predictable phenomenon. The results are expected to contribute to improved interpretation of existing trials, inform future clinical trial design, and provide a conceptual framework for understanding non-pharmacologic contributors to clinical improvement in inflammatory arthritis."
["project_specific_aims"]=>
string(1596) "The goal of this project is to systematically characterize and predict clinical improvement among patients randomized to placebo plus standard of care in phase II and III trials of bDMARDs for RA, PsA, and SpA. Rather than viewing placebo response as random noise, we conceptualize it as a measurable and partially predictable phenomenon with implications for trial interpretation and design.
Aim 1: Quantify the magnitude and variability of placebo response across diseases and trials using disease-specific regulatory endpoints, and describe heterogeneity attributable to trial design versus patient characteristics.
Aim 2: Identify baseline demographic, clinical, laboratory, and patient-reported variables associated with placebo response within each disease using individual participant-level data and multivariable hierarchical models accounting for between-trial heterogeneity.
Aim 3: Characterize temporal patterns of placebo response by distinguishing early from sustained improvement and evaluating whether early changes reflect regression to the mean or durable non-pharmacologic benefit.
Aim 4: Explore multivariable and non-linear predictive patterns using complementary machine-learning approaches. These analyses will be used to complement, not replace, regression-based models and to assess the robustness and generalizability of identified prognostic factors.
Together, these aims will provide a rigorous patient-level understanding of placebo response in inflammatory arthritis trials and inform future trial design and interpretation.
"
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string(2019) "Data Source. This study will use individual participant-level data from randomized, double-blind, placebo-controlled phase II and III clinical trials of bDMARDs in RA, PsA, and SpA made available through the YODA Project. Only data accessed within the secure YODA research platform will be used for all analyses. No external individual-level datasets will be incorporated. Supporting trial documentation will be used to ensure accurate interpretation of trial design, endpoint definitions, and visit schedules.
Inclusion Criteria. For each eligible trial, the study population will consist of participants meeting all of the following criteria:
1. Adult patients (≥18 years of age) enrolled in a randomized, placebo-controlled phase II and III trial of a bDMARD for RA, PsA, or SpA.
2. Randomization to the placebo arm with continuation of background standard of care, as defined by the original trial protocol.
3. Availability of baseline demographic and clinical characteristics prior to randomization.
4. Availability of disease-specific efficacy outcomes at the prespecified primary endpoint (e.g. ACR20 for RA, ASAS20 for SpA, or validated composite response measures for PsA).
5. Availability of follow-up data sufficient to characterize response trajectories where applicable.
Exclusion Criteria. The following exclusion criteria will be applied uniformly across trials:
1. Participants randomized to active treatment arms.
2. Participants enrolled in open-label extension phases or rescue phases after loss of blinding.
3. Participants with missing primary endpoint outcome data at the prespecified timepoint.
4. Participants with protocol deviations that preclude valid assessment of treatment response, as documented in trial records.
No additional exclusion criteria based on disease severity, prior treatment exposure, or concomitant therapies will be applied beyond those defined by the original trial protocols.
"
["project_main_outcome_measure"]=>
string(2066) "Primary Outcome Measure. The primary outcome will be disease-specific, trial-defined clinical improvement assessed at the prespecified primary endpoint of each randomized controlled trial. No harmonization of binary outcomes across diseases into a single pooled endpoint will be attempted. Clinical improvement will be defined according to regulatory-accepted response criteria used in the original protocols, including:
● American College of Rheumatology 20% improvement criteria (ACR20) for RA trials;
● Assessment of Spondyloarthritis International Society 20% response criteria (ASAS20) for SpA trials;
● Validate composite clinical response measures for psoriatic arthritis trials, as specified in individual study protocols.
Secondary Outcome Measures. Secondary outcomes are intended to capture the magnitude, trajectory, and durability of placebo-associated clinical improvement and to distinguish transient from sustained responses. These will include:
1. Continuous change in disease activity indices from baseline to the primary endpoint, including but not limited to DAS28 for RA and ASDAS for SpA, where available.
2. Patient-reported outcomes, including changes in pain visual analogue scale (VAS), patient global assessment, and functional measures such as the Health Assessment Questionnaire Disability Index (HAQ-DI), when collected in the original trials.
3. Temporal response patterns defined using intermediate study visits to classify participants as early responders, sustained responders, or non-responders within the placebo arm.
4. Objective inflammatory markers, including C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), when available, to explore concordance between subjective and objective components of placebo response.
Secondary outcomes will be analyzed descriptively and within multivariable models to support interpretation of the primary endpoint and to explore heterogeneity in placebo response patterns across trials and disease indications."
["project_main_predictor_indep"]=>
string(1426) "The main independent variables are two co-primary baseline predictor domains, assessed prior to randomization among participants assigned to placebo plus standard of care: (A) patient-reported symptom burden and disease impact (PRO domain) and (B) clinician-assessed and laboratory-supported disease activity (clinimetric domain).
PRO domain: baseline pain visual analogue scale (VAS) and patient global assessment, analyzed as continuous variables in original units. Where available, baseline fatigue measures and functional disability indices (e.g. HAQ-DI; BASFI in axial disease populations) will be included.
Clinimetric domain: baseline tender and swollen joint counts (where applicable), enthesitis indices (where applicable), trial-defined composite disease activity measures (e.g. DAS28 for RA; ASDAS for SpA; protocol-defined composite indices for PsA), and acute-phase reactants (CRP and/or ESR).
For comparability across trials, continuous predictors will be analyzed primarily as continuous variables using within-trial standardization (z-scores); secondary analyses will explore clinically meaningful categories when established. A prespecified interaction will assess baseline symptom burden × objective inflammatory activity (e.g. pain or patient global assessment × CRP/ESR or swollen joint count) to evaluate whether symptom–inflammation discordance modifies placebo response.
"
["project_other_variables_interest"]=>
string(1436) "Additional variables will be used to characterize the study sample, adjust multivariable models, and explore prespecified interactions.
Demographic and stable clinical characteristics: age (continuous), sex, disease duration (continuous), body mass index (BMI; continuous), and smoking status (current/former/never), when available.
Disease-related characteristics: serological status in rheumatoid arthritis (RF and/or ACPA positivity), axial versus peripheral disease phenotype in SpA/PsA where defined in trial protocols, and baseline measures of structural or clinical disease involvement as available.
Baseline treatment context: concomitant conventional synthetic DMARD use (yes/no), baseline oral glucocorticoid use (yes/no), NSAID use (yes/no), and prior exposure to biologic DMARDs (biologic-naïve vs biologic-experienced).
Exploratory social and contextual indicators: education level, employment status, and geographic region, when collected and consistently defined across trials, to explore potential social contributions to heterogeneity in placebo response.
Trial-level contextual variables: trial identifier (modeled as a random effect), disease indication, investigational product, and geographic region or calendar period where applicable, to account for between-trial heterogeneity. All variables are prespecified; no data-driven variable selection procedures will be used.
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string(3276) "All analyses will be conducted within the secure YODA Project research platform using standard statistical software (R and/or Stata). The analytic strategy is explicitly prognostic and methodological; no causal treatment effects will be estimated.
General analytic framework
The primary analytic population will consist of participants randomized to placebo plus standard of care. Analyses will be performed separately within each disease indication (RA, PsA, SpA), with results synthesized through hierarchical modeling to account for between-trial heterogeneity. No naïve pooling across trials or diseases will be performed.
Primary analysis
For each disease indication, the association between baseline co-primary predictor domains (PRO domain and clinimetric domain) and the primary binary outcome (trial-defined clinical response at the primary endpoint) will be assessed using multivariable logistic regression models. Models will include trial identifier as a random intercept to account for clustering within trials. Continuous predictors will be modeled primarily as standardized (z-score) variables to facilitate comparability across studies.
The PRO domain and clinimetric domain will be entered jointly into models to estimate their independent prognostic associations. A prespecified interaction term between baseline symptom burden (pain VAS or patient global assessment) and objective inflammatory activity (CRP/ESR or swollen joint count) will be included to evaluate whether symptom–inflammation discordance modifies placebo response.
Secondary analyses
Secondary outcomes, including continuous changes in disease activity indices and patient-reported outcomes, will be analyzed using linear mixed-effects models with random intercepts for trial and fixed effects for prespecified predictors. Longitudinal trajectories will be examined, where intermediate visits are available, to classify early versus sustained placebo response patterns.
Covariate adjustment and exploratory analyses
All models will adjust for prespecified covariates including age, sex, disease duration, BMI, smoking status, baseline treatment context (concomitant csDMARDs, glucocorticoids, NSAIDs), prior biologic exposure, and selected trial-level characteristics. Exploratory analyses will evaluate the contribution of social/contextual indicators (education level, employment status, geographic region) when consistently available.
Sensitivity analyses
Sensitivity analyses will assess robustness of findings by: (1) alternative categorizations of continuous predictors; (2) exclusion of trials with atypical placebo response rates; and (3) restriction to biologic-naïve populations where applicable. Missing baseline data will be addressed using appropriate multiple imputation methods under missing-at-random assumptions.
Model validation and reporting
Model performance will be evaluated using internal validation techniques, including cross-validation where appropriate. Results will be reported as effect estimates with 95% confidence intervals, with transparent reporting of heterogeneity and model assumptions in accordance with STROBE [10] and TRIPOD [11] recommendations.
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string(1140) "The proposed project is expected to be completed within approximately 9–10 months from data access approval.
Months 1–2: Administrative setup and data access through the YODA secure platform; review of clinical study reports and protocols; harmonization of variable definitions across trials; construction of the analytic dataset and data quality checks.
Months 3–4: Descriptive analyses of placebo response rates across trials and disease indications; primary multivariable analyses assessing baseline predictors of placebo response within each disease indication.
Months 5–6: Secondary and exploratory analyses, including longitudinal trajectory analyses, prespecified interaction testing, and sensitivity analyses; internal validation of models.
Months 7–8: Interpretation of findings in relation to trial design and methodological implications; preparation of tables, figures, and draft manuscript.
Month 9: Manuscript revision, submission to a peer-reviewed journal, and preparation of abstracts for presentation at international rheumatology or clinical trial methodology meetings.
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string(1431) "The definitive results of this study will be disseminated through peer-reviewed scientific publications and presentations at international meetings, with a focus on both rheumatology and clinical trial methodology audiences. The primary manuscript will be submitted to a high-impact, peer-reviewed journal in rheumatology or clinical epidemiology, ensuring transparent reporting of methods and results.
Findings with direct relevance to clinical trial design and interpretation will be presented at major international conferences (e.g., EULAR, ACR) and, where appropriate, at meetings focused on clinical research methodology. Abstracts and presentations will emphasize methodological implications, including implications for endpoint interpretation, placebo response heterogeneity, and future trial design.
To promote transparency and reproducibility, analytic code and derived variable definitions (excluding any participant-level data) will be made available upon publication, in accordance with YODA Project data use agreements and journal policies. Results will be reported following established reporting guidelines for observational and prognostic research (STROBE and TRIPOD).
No individual participant-level data will be shared outside the YODA secure platform. All dissemination activities will preserve participant confidentiality and comply fully with YODA Project governance requirements.
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["project_bibliography"]=>
string(3052) "1 – DI Matteo A, Emery P. Rheumatoid arthritis: a review of the key clinical features and ongoing challenges of the disease. Panminerva Med. 2024 Dec;66(4):427-442. doi: 10.23736/S0031-0808.24.05272-8. Epub 2024 Dec 2. PMID: 39621317.
2 – Lopez-Medina C, Kalyoncu U, Gossec L. Unmet needs in psoriatic arthritis, a narrative review. Arch Rheumatol. 2024 May 5;39(2):159-171. doi: 10.46497/ArchRheumatol.2024.10710. PMID: 38933724; PMCID: PMC11196227.
3 – Ivanova M, Zimba O, Dimitrov I, Angelov AK, Georgiev T. Axial Spondyloarthritis: an overview of the disease. Rheumatol Int. 2024 Sep;44(9):1607-1619. doi: 10.1007/s00296-024-05601-9. Epub 2024 Apr 30. PMID: 38689098.
4 – Bechman K, Yates M, Norton S, Cope AP, Galloway JB. Placebo Response in Rheumatoid Arthritis Clinical Trials. J Rheumatol. 2020 Jan;47(1):28-34. doi: 10.3899/jrheum.190008. Epub 2019 May 1. PMID: 31043548; PMCID: PMC6941937.
5 – Nagai K, Matsubayashi K, Ide K, Seto K, Kawasaki Y, Kawakami K. Factors Influencing Placebo Responses in Rheumatoid Arthritis Clinical Trials: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Studies. Clin Drug Investig. 2020 Mar;40(3):197-209. doi: 10.1007/s40261-020-00887-6. PMID: 31953723.
6 – Erre GL, Mavridis D, Woodman RJ, Mangoni AA. Placebo response in psoriatic arthritis clinical trials: a systematic review and meta-analysis. Rheumatology (Oxford). 2022 Apr 11;61(4):1328-1340. doi: 10.1093/rheumatology/keab774. PMID: 34664615.
7 – Perrot L, Molto A, Paris C, Gravier Dumonceau R, Dougados M, Pham T. Evaluation of the placebo and treatment effect overtime in randomised clinical trials evaluating the efficacy of biologics in axial spondyloarthritis: systematic review and meta-analysis. Ann Rheum Dis. 2026 Mar;85(3):467-475. doi: 10.1016/j.ard.2025.11.010. Epub 2025 Dec 25. PMID: 41448991.
8 – ICH E10: Choice of Control Group and Related Issues in Clinical Trials. 2000, https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-10-choice-control-group-clinical-trials-step-5_en.pdf
9 – Vollert J, Cook NR, Kaptchuk TJ, Sehra ST, Tobias DK, Hall KT. Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials. JAMA Netw Open. 2020 Sep 1;3(9):e2013196. doi: 10.1001/jamanetworkopen.2020.13196. PMID: 32936297; PMCID: PMC7495232.
10 – von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008. PMID: 18313558.
11 – Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. BMJ. 2015 Jan 7;350:g7594. doi: 10.1136/bmj.g7594. PMID: 25569120.
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General Information
How did you learn about the YODA Project?:
Colleague
Conflict of Interest
Request Clinical Trials
Associated Trial(s):
- NCT03158285 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
- NCT03162796 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNF Alpha Agents
- NCT01077362 - A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
- NCT01009086 - A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
- NCT00265083 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis
- NCT00299546 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti TNFa Agent(s)
- NCT00051623 - A Multicenter, Randomized, Double-blind Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Patients With Psoriatic Arthritis
- NCT00207701 - A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy
- NCT00036387 - A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug
- NCT00207714 - A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
- NCT00236028 - A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis
- NCT00264537 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis
- NCT00264550 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy
- NCT00269867 - A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
- NCT00361335 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy
- NCT00973479 - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
- NCT01004432 - Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
- NCT01248780 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy
- NCT01604343 - A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite DMARD Therapy
- NCT01606761 - A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy
- NCT01645280 - A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy
- NCT01689532 - A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine
- NCT01962974 - A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
- NCT01248793 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects with Ankylosing Spondylitis
- NCT01453725 - A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Also Known as MK-8259-006-02)
- NCT02407223 - A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
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Individual Participant-Level Data, which includes Full CSR and all supporting documentation
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Status:
Ongoing
Research Proposal
Project Title:
Predictors of Placebo Response in Randomized Controlled Trials of Biologic DMARDs for RA, PsA, and SpA
Scientific Abstract:
Background: Randomized controlled trials (RCTs) of biologic antirheumatic drugs (bDMARDs) in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and spondyloarthritis (SpA)consistently report significant improvement in a proportion of patients randomized to placebo, the causes of which are poorly investigated. Objective: To identify predictors of placebo response in phase III placebo‑controlled RCTs of bDMARDs in RA, PsA, and SpA, and to characterize patterns of early and sustained placebo responsiveness. Study Design: Analysis of participant-level data from randomized, double-blind, placebo-controlled phase II and III trials of bDMARDs. Hierarchical and stratified models will be used to account for between-trial/disease/drug heterogeneity. Participants: Adult patients with RA, PsA, or SpA randomized to placebo plus background standard of care, with available baseline characteristics and prespecified efficacy endpoints. Primary and Secondary Outcome Measures: 1) Achievement of disease‑specific, trial‑defined clinical improvement at the primary endpoint. 2) Continuous change in disease activity indices, patient‑reported outcomes including pain and global assessment, and characterization of early versus sustained placebo response trajectories. Statistical Analysis: Multivariable logistic and mixed‑effects regression models will be used to identify independent predictors of placebo response. Penalized regression and machine‑learning approaches will explore non‑linear associations. Model robustness will be assessed using cross‑validation and sensitivity analyses.
Brief Project Background and Statement of Project Significance:
Placebo response is a clinically relevant phenomenon in randomized controlled trials (RCTs) of inflammatory rheumatic diseases. Across phase II and III trials of biologic disease-modifying antirheumatic drugs (bDMARDs) in RA, PsA, and SpA [1, 2, 3], a substantial proportion of patients randomized to placebo achieve clinically meaningful and sustained responses, contributing to variability in observed treatment effects across trials [4, 5, 6, 7]. From a drug development and regulatory perspective, high and variable placebo response rates represent a major source of statistical and interpretative uncertainty, as they reduce assay sensitivity, inflate required sample sizes, and may obscure true differences between investigational products [8]. This is a relevant issue in rheumatology, where composite endpoints incorporate objective inflammatory markers and patient-reported components such as pain, fatigue, and global assessment, which are intrinsically sensitive to context and expectancies. As a result, trials evaluating similar interventions in comparable populations may yield different apparent efficacy profiles, driven in part by differences in placebo responsiveness rather than pharmacologic effect. Despite its importance, placebo response is often treated as statistical noise rather than as a clinically and methodologically meaningful phenomenon. Existing literature largely relies on trial-level summaries or post-hoc subgroup analyses, which are limited by ecological bias and inability to disentangle patient-level predictors. Moreover, most studies focus on a single disease or individual trial, limiting generalizability and preventing systematic evaluation of shared versus disease-specific determinants of placebo response. The implication of this evaluation go beyond methodological refinement. From a clinical standpoint, placebo responsiveness may reflect underlying disease characteristics such as lower inflammatory burden, symptom-inflammation discordance, or heightened sensitivity to contextual care effects [9]. From a trial design perspective, identifying predictors of placebo response could inform enrichment or stratification strategies, improve power calculations, and support more efficient and ethical study designs by reducing unnecessary exposure to inactive treatments. The availability of individual participant-level data (IPD) from multiple placebo-controlled RCTs through the YODA Project provides a unique opportunity to address this knowledge gap, by allowing direct modeling of patient-level predictors while explicitly accounting for between-trial heterogeneity in design, population, disease indication, and outcome definition. By systematically identifying and validating predictors of placebo response across RA, PsA, and SpA trial populations, this study seeks to reframe placebo response from an unavoidable nuisance to a measurable and partially predictable phenomenon. The results are expected to contribute to improved interpretation of existing trials, inform future clinical trial design, and provide a conceptual framework for understanding non-pharmacologic contributors to clinical improvement in inflammatory arthritis.
Specific Aims of the Project:
The goal of this project is to systematically characterize and predict clinical improvement among patients randomized to placebo plus standard of care in phase II and III trials of bDMARDs for RA, PsA, and SpA. Rather than viewing placebo response as random noise, we conceptualize it as a measurable and partially predictable phenomenon with implications for trial interpretation and design.
Aim 1: Quantify the magnitude and variability of placebo response across diseases and trials using disease-specific regulatory endpoints, and describe heterogeneity attributable to trial design versus patient characteristics.
Aim 2: Identify baseline demographic, clinical, laboratory, and patient-reported variables associated with placebo response within each disease using individual participant-level data and multivariable hierarchical models accounting for between-trial heterogeneity.
Aim 3: Characterize temporal patterns of placebo response by distinguishing early from sustained improvement and evaluating whether early changes reflect regression to the mean or durable non-pharmacologic benefit.
Aim 4: Explore multivariable and non-linear predictive patterns using complementary machine-learning approaches. These analyses will be used to complement, not replace, regression-based models and to assess the robustness and generalizability of identified prognostic factors.
Together, these aims will provide a rigorous patient-level understanding of placebo response in inflammatory arthritis trials and inform future trial design and interpretation.
Study Design:
Methodological research
What is the purpose of the analysis being proposed? Please select all that apply.:
Research on clinical trial methods
Research on clinical prediction or risk prediction
Software Used:
R, RStudio, STATA
Data Source and Inclusion/Exclusion Criteria to be used to define the patient sample for your study:
Data Source. This study will use individual participant-level data from randomized, double-blind, placebo-controlled phase II and III clinical trials of bDMARDs in RA, PsA, and SpA made available through the YODA Project. Only data accessed within the secure YODA research platform will be used for all analyses. No external individual-level datasets will be incorporated. Supporting trial documentation will be used to ensure accurate interpretation of trial design, endpoint definitions, and visit schedules.
Inclusion Criteria. For each eligible trial, the study population will consist of participants meeting all of the following criteria:
1. Adult patients (>=18 years of age) enrolled in a randomized, placebo-controlled phase II and III trial of a bDMARD for RA, PsA, or SpA.
2. Randomization to the placebo arm with continuation of background standard of care, as defined by the original trial protocol.
3. Availability of baseline demographic and clinical characteristics prior to randomization.
4. Availability of disease-specific efficacy outcomes at the prespecified primary endpoint (e.g. ACR20 for RA, ASAS20 for SpA, or validated composite response measures for PsA).
5. Availability of follow-up data sufficient to characterize response trajectories where applicable.
Exclusion Criteria. The following exclusion criteria will be applied uniformly across trials:
1. Participants randomized to active treatment arms.
2. Participants enrolled in open-label extension phases or rescue phases after loss of blinding.
3. Participants with missing primary endpoint outcome data at the prespecified timepoint.
4. Participants with protocol deviations that preclude valid assessment of treatment response, as documented in trial records.
No additional exclusion criteria based on disease severity, prior treatment exposure, or concomitant therapies will be applied beyond those defined by the original trial protocols.
Primary and Secondary Outcome Measure(s) and how they will be categorized/defined for your study:
Primary Outcome Measure. The primary outcome will be disease-specific, trial-defined clinical improvement assessed at the prespecified primary endpoint of each randomized controlled trial. No harmonization of binary outcomes across diseases into a single pooled endpoint will be attempted. Clinical improvement will be defined according to regulatory-accepted response criteria used in the original protocols, including:
● American College of Rheumatology 20% improvement criteria (ACR20) for RA trials;
● Assessment of Spondyloarthritis International Society 20% response criteria (ASAS20) for SpA trials;
● Validate composite clinical response measures for psoriatic arthritis trials, as specified in individual study protocols.
Secondary Outcome Measures. Secondary outcomes are intended to capture the magnitude, trajectory, and durability of placebo-associated clinical improvement and to distinguish transient from sustained responses. These will include:
1. Continuous change in disease activity indices from baseline to the primary endpoint, including but not limited to DAS28 for RA and ASDAS for SpA, where available.
2. Patient-reported outcomes, including changes in pain visual analogue scale (VAS), patient global assessment, and functional measures such as the Health Assessment Questionnaire Disability Index (HAQ-DI), when collected in the original trials.
3. Temporal response patterns defined using intermediate study visits to classify participants as early responders, sustained responders, or non-responders within the placebo arm.
4. Objective inflammatory markers, including C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), when available, to explore concordance between subjective and objective components of placebo response.
Secondary outcomes will be analyzed descriptively and within multivariable models to support interpretation of the primary endpoint and to explore heterogeneity in placebo response patterns across trials and disease indications.
Main Predictor/Independent Variable and how it will be categorized/defined for your study:
The main independent variables are two co-primary baseline predictor domains, assessed prior to randomization among participants assigned to placebo plus standard of care: (A) patient-reported symptom burden and disease impact (PRO domain) and (B) clinician-assessed and laboratory-supported disease activity (clinimetric domain).
PRO domain: baseline pain visual analogue scale (VAS) and patient global assessment, analyzed as continuous variables in original units. Where available, baseline fatigue measures and functional disability indices (e.g. HAQ-DI; BASFI in axial disease populations) will be included.
Clinimetric domain: baseline tender and swollen joint counts (where applicable), enthesitis indices (where applicable), trial-defined composite disease activity measures (e.g. DAS28 for RA; ASDAS for SpA; protocol-defined composite indices for PsA), and acute-phase reactants (CRP and/or ESR).
For comparability across trials, continuous predictors will be analyzed primarily as continuous variables using within-trial standardization (z-scores); secondary analyses will explore clinically meaningful categories when established. A prespecified interaction will assess baseline symptom burden x objective inflammatory activity (e.g. pain or patient global assessment x CRP/ESR or swollen joint count) to evaluate whether symptom--inflammation discordance modifies placebo response.
Other Variables of Interest that will be used in your analysis and how they will be categorized/defined for your study:
Additional variables will be used to characterize the study sample, adjust multivariable models, and explore prespecified interactions.
Demographic and stable clinical characteristics: age (continuous), sex, disease duration (continuous), body mass index (BMI; continuous), and smoking status (current/former/never), when available.
Disease-related characteristics: serological status in rheumatoid arthritis (RF and/or ACPA positivity), axial versus peripheral disease phenotype in SpA/PsA where defined in trial protocols, and baseline measures of structural or clinical disease involvement as available.
Baseline treatment context: concomitant conventional synthetic DMARD use (yes/no), baseline oral glucocorticoid use (yes/no), NSAID use (yes/no), and prior exposure to biologic DMARDs (biologic-naïve vs biologic-experienced).
Exploratory social and contextual indicators: education level, employment status, and geographic region, when collected and consistently defined across trials, to explore potential social contributions to heterogeneity in placebo response.
Trial-level contextual variables: trial identifier (modeled as a random effect), disease indication, investigational product, and geographic region or calendar period where applicable, to account for between-trial heterogeneity. All variables are prespecified; no data-driven variable selection procedures will be used.
Statistical Analysis Plan:
All analyses will be conducted within the secure YODA Project research platform using standard statistical software (R and/or Stata). The analytic strategy is explicitly prognostic and methodological; no causal treatment effects will be estimated.
General analytic framework
The primary analytic population will consist of participants randomized to placebo plus standard of care. Analyses will be performed separately within each disease indication (RA, PsA, SpA), with results synthesized through hierarchical modeling to account for between-trial heterogeneity. No naïve pooling across trials or diseases will be performed.
Primary analysis
For each disease indication, the association between baseline co-primary predictor domains (PRO domain and clinimetric domain) and the primary binary outcome (trial-defined clinical response at the primary endpoint) will be assessed using multivariable logistic regression models. Models will include trial identifier as a random intercept to account for clustering within trials. Continuous predictors will be modeled primarily as standardized (z-score) variables to facilitate comparability across studies.
The PRO domain and clinimetric domain will be entered jointly into models to estimate their independent prognostic associations. A prespecified interaction term between baseline symptom burden (pain VAS or patient global assessment) and objective inflammatory activity (CRP/ESR or swollen joint count) will be included to evaluate whether symptom--inflammation discordance modifies placebo response.
Secondary analyses
Secondary outcomes, including continuous changes in disease activity indices and patient-reported outcomes, will be analyzed using linear mixed-effects models with random intercepts for trial and fixed effects for prespecified predictors. Longitudinal trajectories will be examined, where intermediate visits are available, to classify early versus sustained placebo response patterns.
Covariate adjustment and exploratory analyses
All models will adjust for prespecified covariates including age, sex, disease duration, BMI, smoking status, baseline treatment context (concomitant csDMARDs, glucocorticoids, NSAIDs), prior biologic exposure, and selected trial-level characteristics. Exploratory analyses will evaluate the contribution of social/contextual indicators (education level, employment status, geographic region) when consistently available.
Sensitivity analyses
Sensitivity analyses will assess robustness of findings by: (1) alternative categorizations of continuous predictors; (2) exclusion of trials with atypical placebo response rates; and (3) restriction to biologic-naïve populations where applicable. Missing baseline data will be addressed using appropriate multiple imputation methods under missing-at-random assumptions.
Model validation and reporting
Model performance will be evaluated using internal validation techniques, including cross-validation where appropriate. Results will be reported as effect estimates with 95% confidence intervals, with transparent reporting of heterogeneity and model assumptions in accordance with STROBE [10] and TRIPOD [11] recommendations.
Narrative Summary:
Many patients participating in clinical trials for rheumatic diseases show meaningful improvement even when receiving placebo plus standard care. This phenomenon complicates the interpretation of treatment effects but remains poorly understood. This project will analyze individual participant data from multiple randomized trials of biologic drugs in rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis to identify characteristics that predict response to placebo. By examining demographic, clinical, and psychosocial factors, we aim to clarify why some patients improve without active treatment. Understanding these mechanisms may improve trial design, refine patient selection, and offer new insights into disease variability.
Project Timeline:
The proposed project is expected to be completed within approximately 9--10 months from data access approval.
Months 1--2: Administrative setup and data access through the YODA secure platform; review of clinical study reports and protocols; harmonization of variable definitions across trials; construction of the analytic dataset and data quality checks.
Months 3--4: Descriptive analyses of placebo response rates across trials and disease indications; primary multivariable analyses assessing baseline predictors of placebo response within each disease indication.
Months 5--6: Secondary and exploratory analyses, including longitudinal trajectory analyses, prespecified interaction testing, and sensitivity analyses; internal validation of models.
Months 7--8: Interpretation of findings in relation to trial design and methodological implications; preparation of tables, figures, and draft manuscript.
Month 9: Manuscript revision, submission to a peer-reviewed journal, and preparation of abstracts for presentation at international rheumatology or clinical trial methodology meetings.
Dissemination Plan:
The definitive results of this study will be disseminated through peer-reviewed scientific publications and presentations at international meetings, with a focus on both rheumatology and clinical trial methodology audiences. The primary manuscript will be submitted to a high-impact, peer-reviewed journal in rheumatology or clinical epidemiology, ensuring transparent reporting of methods and results.
Findings with direct relevance to clinical trial design and interpretation will be presented at major international conferences (e.g., EULAR, ACR) and, where appropriate, at meetings focused on clinical research methodology. Abstracts and presentations will emphasize methodological implications, including implications for endpoint interpretation, placebo response heterogeneity, and future trial design.
To promote transparency and reproducibility, analytic code and derived variable definitions (excluding any participant-level data) will be made available upon publication, in accordance with YODA Project data use agreements and journal policies. Results will be reported following established reporting guidelines for observational and prognostic research (STROBE and TRIPOD).
No individual participant-level data will be shared outside the YODA secure platform. All dissemination activities will preserve participant confidentiality and comply fully with YODA Project governance requirements.
Bibliography:
1 – DI Matteo A, Emery P. Rheumatoid arthritis: a review of the key clinical features and ongoing challenges of the disease. Panminerva Med. 2024 Dec;66(4):427-442. doi: 10.23736/S0031-0808.24.05272-8. Epub 2024 Dec 2. PMID: 39621317.
2 – Lopez-Medina C, Kalyoncu U, Gossec L. Unmet needs in psoriatic arthritis, a narrative review. Arch Rheumatol. 2024 May 5;39(2):159-171. doi: 10.46497/ArchRheumatol.2024.10710. PMID: 38933724; PMCID: PMC11196227.
3 – Ivanova M, Zimba O, Dimitrov I, Angelov AK, Georgiev T. Axial Spondyloarthritis: an overview of the disease. Rheumatol Int. 2024 Sep;44(9):1607-1619. doi: 10.1007/s00296-024-05601-9. Epub 2024 Apr 30. PMID: 38689098.
4 – Bechman K, Yates M, Norton S, Cope AP, Galloway JB. Placebo Response in Rheumatoid Arthritis Clinical Trials. J Rheumatol. 2020 Jan;47(1):28-34. doi: 10.3899/jrheum.190008. Epub 2019 May 1. PMID: 31043548; PMCID: PMC6941937.
5 – Nagai K, Matsubayashi K, Ide K, Seto K, Kawasaki Y, Kawakami K. Factors Influencing Placebo Responses in Rheumatoid Arthritis Clinical Trials: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Studies. Clin Drug Investig. 2020 Mar;40(3):197-209. doi: 10.1007/s40261-020-00887-6. PMID: 31953723.
6 – Erre GL, Mavridis D, Woodman RJ, Mangoni AA. Placebo response in psoriatic arthritis clinical trials: a systematic review and meta-analysis. Rheumatology (Oxford). 2022 Apr 11;61(4):1328-1340. doi: 10.1093/rheumatology/keab774. PMID: 34664615.
7 – Perrot L, Molto A, Paris C, Gravier Dumonceau R, Dougados M, Pham T. Evaluation of the placebo and treatment effect overtime in randomised clinical trials evaluating the efficacy of biologics in axial spondyloarthritis: systematic review and meta-analysis. Ann Rheum Dis. 2026 Mar;85(3):467-475. doi: 10.1016/j.ard.2025.11.010. Epub 2025 Dec 25. PMID: 41448991.
8 – ICH E10: Choice of Control Group and Related Issues in Clinical Trials. 2000, https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-10-choice-control-group-clinical-trials-step-5_en.pdf
9 – Vollert J, Cook NR, Kaptchuk TJ, Sehra ST, Tobias DK, Hall KT. Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials. JAMA Netw Open. 2020 Sep 1;3(9):e2013196. doi: 10.1001/jamanetworkopen.2020.13196. PMID: 32936297; PMCID: PMC7495232.
10 – von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008. PMID: 18313558.
11 – Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. BMJ. 2015 Jan 7;350:g7594. doi: 10.1136/bmj.g7594. PMID: 25569120.
