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NCT00624338 · ClinicalTrials.gov registry record · Phase 2
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 461
- Enrollment target
NCT00624338: Completed Phase 2 study, sponsored by EMD Serono.
NCT00624338 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 461 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (247% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00624338, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 461 participants
- Enrollment target
Study Summary
This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.
Primary Outcome
A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follo
Interventions
- OTHER Placebo Comparator
- DRUG Atacicept 75 mg
- DRUG Atacicept 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT00624338 record still lists
NCT00624338 is an interventional study that assigns participants to a tested intervention. The registered 461 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 (247% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT00624338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00624338 about?
NCT00624338 is a clinical study titled "Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)". This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers s...
What is the current status of trial NCT00624338?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 461 participants. The study started on 2008-01. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00624338?
The interventions under investigation include: Placebo Comparator (OTHER), Atacicept 75 mg (DRUG), Atacicept 150 mg (DRUG).
Who is sponsoring clinical trial NCT00624338?
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 NCT00624338's enrollment target sits among peer trials
461 82nd of 2000 higher than 1,918 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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