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NCT01500278 · ClinicalTrials.gov registry record · Phase 4
Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate
A Phase 4 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 915
- Enrollment target
NCT01500278: Completed Phase 4 study, sponsored by UCB Pharma.
NCT01500278 is a Phase 4 study that has completed, run by UCB Pharma. The registered enrollment target is 915 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01500278, a Phase 4 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 915 participants
- Enrollment target
Study Summary
This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.
Primary Outcome
Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Dise
Interventions
- DRUG Methotrexate (MTX)
- BIOLOGICAL Adalimumab (ADA)
- BIOLOGICAL Certolizumab Pegol (CZP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 915 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-01 |
| Phase | Phase 4 |
What the finished NCT01500278 record still lists
NCT01500278 is an interventional study that assigns participants to a tested intervention. The registered 915 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 3 interventions - of which Methotrexate (MTX) is the first listed.
NCT01500278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01500278 about?
NCT01500278 is a clinical study titled "Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate". This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.
What is the current status of trial NCT01500278?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 915 participants. The study started on 2011-12. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01500278?
The interventions under investigation include: Methotrexate (MTX) (DRUG), Adalimumab (ADA) (BIOLOGICAL), Certolizumab Pegol (CZP) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01500278?
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 NCT01500278's enrollment target sits among peer trials
915 81st of 2000 higher than 1,920 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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