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NCT01519791 · ClinicalTrials.gov registry record · Phase 3
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 880
- Enrollment target
NCT01519791: Completed Phase 3 study, sponsored by UCB Pharma.
NCT01519791 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 880 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519791, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 880 participants
- Enrollment target
Study Summary
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.
Primary Outcome
Sustained remission is defined as a Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) \< 2.6 at both Weeks 40 and 52. DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are exa
Interventions
- OTHER Placebo
- BIOLOGICAL Certolizumab Pegol
- BIOLOGICAL Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 880 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT01519791 record still lists
NCT01519791 is an interventional study that assigns participants to a tested intervention. The registered 880 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01519791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519791 about?
NCT01519791 is a clinical study titled "A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis". This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.
What is the current status of trial NCT01519791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 880 participants. The study started on 2012-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01519791?
The interventions under investigation include: Placebo (OTHER), Certolizumab Pegol (BIOLOGICAL), Methotrexate (BIOLOGICAL).
Who is sponsoring clinical trial NCT01519791?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01519791's enrollment target sits among peer trials
880 367th of 2000 higher than 1,631 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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