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NCT00580840 · ClinicalTrials.gov registry record · Phase 4
Dosing Flexibility Study in Patients With Rheumatoid Arthritis
A Phase 4 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 333
- Enrollment target
NCT00580840: Completed Phase 4 study, sponsored by UCB Pharma.
NCT00580840 is a Phase 4 study that has completed, run by UCB Pharma. The registered enrollment target is 333 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00580840, a Phase 4 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 333 participants
- Enrollment target
Study Summary
During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.
Primary Outcome
ACR20 responders are 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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values w
Interventions
- OTHER Placebo
- DRUG Certolizumab pegol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2007-12 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
What the finished NCT00580840 record still lists
NCT00580840 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00580840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00580840 about?
NCT00580840 is a clinical study titled "Dosing Flexibility Study in Patients With Rheumatoid Arthritis". During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.
What is the current status of trial NCT00580840?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 333 participants. The study started on 2007-12. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00580840?
The interventions under investigation include: Placebo (OTHER), Certolizumab pegol (DRUG).
Who is sponsoring clinical trial NCT00580840?
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 NCT00580840's enrollment target sits among peer trials
333 252nd of 2000 higher than 1,748 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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