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NCT00430495 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
NCT00430495: Completed Phase 2 study, sponsored by EMD Serono.
NCT00430495 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 256 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00430495, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
Study Summary
This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.
Primary Outcome
ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase
Interventions
- DRUG Atacicept
- DRUG Placebo matched to atacicept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
What the finished NCT00430495 record still lists
NCT00430495 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 2 interventions - of which Atacicept is the first listed.
NCT00430495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00430495 about?
NCT00430495 is a clinical study titled "A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)". This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack ...
What is the current status of trial NCT00430495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2006-12. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00430495?
The interventions under investigation include: Atacicept (DRUG), Placebo matched to atacicept (DRUG).
Who is sponsoring clinical trial NCT00430495?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00430495's enrollment target sits among peer trials
256 215th of 2000 higher than 1,783 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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