Trial reportAnnals of the rheumatic diseases2009
Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial.
Trial report in Annals of the rheumatic diseases, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 189 papers, 35 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Multi-center, Double-blind, Placebo-controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.
A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Who cites it
189 citing papers in PubMed, 35 syntheses or guidelines pooled it.
- Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study.Health technology assessment (Winchester, England) · 2026Pooled it
- Can Methotrexate Monotherapy Achieve Clinical Remission in Patients with Active Rheumatoid Arthritis? A Model-Based Meta-Analysis.Journal of clinical pharmacology · 2025Pooled it
- Efficacy of pharmacological interventions and therapeutic exercises for rheumatoid arthritis: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Remission definitions guiding immunosuppressive therapy in rheumatoid arthritis: which is best fitted for the purpose?RMD open · 2024Pooled it
- Rational approach to the prescription of anti-rheumatic drugs in rheumatoid arthritis: a product leaflet-based strategy in Italy.Frontiers in immunology · 2024Pooled it
- Estimating Patient-Specific Relative Benefit of Adding Biologics to Conventional Rheumatoid Arthritis Treatment: An Individual Participant Data Meta-Analysis.JAMA network open · 2023Pooled it
- The Risk of Adverse Effects of TNF-α Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis.Frontiers in immunology · 2022Pooled it
- New Rheumatoid Arthritis Treatments for 'Old' Patients: Results of a Systematic Review.Advances in therapy · 2020Pooled it
- Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry.RMD open · 2020Pooled it
- Placebo Response in Rheumatoid Arthritis Clinical Trials.The Journal of rheumatology · 2020Pooled it
- Intensive therapy and remissions in rheumatoid arthritis: a systematic review.BMC musculoskeletal disorders · 2018Pooled it
- Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Pooled it
- Risk of tuberculosis in patients treated with TNF-α antagonists: a systematic review and meta-analysis of randomised controlled trials.BMJ open · 2017Pooled it
- Biologic or tofacitinib monotherapy for rheumatoid arthritis in people with traditional disease-modifying anti-rheumatic drug (DMARD) failure: a Cochrane Systematic Review and network meta-analysis (NMA).The Cochrane database of systematic reviews · 2016Pooled it
- Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying anti-rheumatic drugs for rheumatoid arthritis: A network meta-analysis.The Cochrane database of systematic reviews · 2016Pooled it
- Meta-analysis of long-term joint structural deterioration in minimally treated patients with rheumatoid arthritis.BMC musculoskeletal disorders · 2016Pooled it
- Short-Term Efficacy Reliably Predicts Long-Term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-Based Meta-Analysis.Journal of clinical pharmacology · 2016Pooled it
- Biologic interventions for fatigue in rheumatoid arthritis.The Cochrane database of systematic reviews · 2016Pooled it
- Pooled it
129 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCertolizumab pegol is a PEGylated tumour necrosis factor inhibitor.
objectiveTo evaluate the efficacy and safety of certolizumab pegol versus placebo, plus methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
methodsAn international, multicentre, phase 3, randomised, double-blind, placebo-controlled study in active adult-onset RA. Patients (n = 619) were randomised 2:2:1 to subcutaneous certolizumab pegol (liquid formulation) 400 mg at weeks 0, 2 and 4 followed by 200 mg or 400 mg plus MTX, or placebo plus MTX, every 2 weeks for 24 weeks. The primary end point was ACR20 response at week 24. Secondary end points included ACR50 and ACR70 responses, change from baseline in modified Total Sharp Score, ACR core set variables and physical function.
resultsSignificantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response versus placebo (p< or =0.001); rates were 57.3%, 57.6% and 8.7%, respectively. Certolizumab pegol 200 and 400 mg also significantly inhibited radiographic progression; mean changes from baseline in mTSS at week 24 were 0.2 and -0.4, respectively, versus 1.2 for placebo (rank analysis p< or =0.01). Certolizumab pegol-treated patients reported rapid and significant improvements in physical function versus placebo; mean changes from baseline in HAQ-DI at week 24 were -0.50 and -0.50, respectively, versus -0.14 for placebo (p< or =0.001). Most adverse events were mild or moderate, with low incidence of withdrawals due to adverse events. Five patients developed tuberculosis.
conclusionCertolizumab pegol plus MTX was more efficacious than placebo plus MTX, rapidly and significantly improving signs and symptoms of RA and physical function and inhibiting radiographic progression. TRIAL REGISTRATION NUMBER: NCT00175877.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.