Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01521923 · 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
- 359
- Enrollment target
NCT01521923: Completed Phase 3 study, sponsored by UCB Pharma.
NCT01521923 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 359 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01521923, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 359 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 sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.
Primary Outcome
This Outcome Measure includes all subjects that have a DAS28 \[ESR\] \<= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.
Interventions
- BIOLOGICAL Certolizumab Pegol + Methotrexate (MTX)
- BIOLOGICAL Placebo + Methotrexate (MTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 359 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT01521923 record still lists
NCT01521923 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Certolizumab Pegol + Methotrexate (MTX) is the first listed.
NCT01521923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01521923 about?
NCT01521923 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 sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at We...
What is the current status of trial NCT01521923?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 359 participants. The study started on 2012-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01521923?
The interventions under investigation include: Certolizumab Pegol + Methotrexate (MTX) (BIOLOGICAL), Placebo + Methotrexate (MTX) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01521923?
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 NCT01521923's enrollment target sits among peer trials
359 1021st of 2000 higher than 979 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05118789 · 359 participants · Phase 1
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
- NCT02747836 · 360 participants
Ultrasound Analysis of Human Carpal Tunnel System
- NCT04089046 · 360 participants · NA
Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)
- NCT04130503 · 360 participants · NA
The Recovery in Stroke Using PAP Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia