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NCT00595413 · ClinicalTrials.gov registry record · Phase 2
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 311
- Enrollment target
NCT00595413: Completed Phase 2 study, sponsored by EMD Serono.
NCT00595413 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 311 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (134% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00595413, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 311 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.
Primary Outcome
ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) improvement from Baseline 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 from Baseline 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 f
Interventions
- BIOLOGICAL Adalimumab
- DRUG Atacicept
- DRUG Placebo matched to atacicept
- DRUG Atacicept: with loading dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00595413 record still lists
NCT00595413 is an interventional study that assigns participants to a tested intervention. The registered 311 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 (134% higher).
The record links to 0 conditions, and to 4 interventions - of which Adalimumab is the first listed.
NCT00595413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00595413 about?
NCT00595413 is a clinical study titled "Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)". The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alph...
What is the current status of trial NCT00595413?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 311 participants. The study started on 2007-09. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00595413?
The interventions under investigation include: Adalimumab (BIOLOGICAL), Atacicept (DRUG), Placebo matched to atacicept (DRUG), Atacicept: with loading dose (DRUG).
Who is sponsoring clinical trial NCT00595413?
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 NCT00595413's enrollment target sits among peer trials
311 162nd of 2000 higher than 1,839 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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