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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 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 311 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00595413
The ClinicalTrials.gov registry entry for NCT00595413 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 311 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Adalimumab is the first listed.
NCT00595413 reports 0 study locations.
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.
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