Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
Public ClinicalTrials.gov record NCT00624338. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00624338
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 461 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2008 (Type not available)
- Primary completion
- Apr 2012 (Actual)
- Completion
- Oct 2012 (Actual)
- Last update posted
- Mar 14, 2016
2008 – 2012
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Division of Clinical Immunology and Rheumatology - UAB | Birmingham | Alabama | 35249-7201 | — |
| Stanford University | Palo Alto | California | — | — |
| Research Site | San Diego | California | — | — |
| Inland Rheumatology Clinical Trials Inc | Upland | California | — | — |
| Research Site | Jacksonville | Florida | — | — |
| Research Site | Boise | Idaho | — | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| US Local Medical Information | Rockland | Massachusetts | 02370 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Justus J. Fiechtner, MD, MPH | Lansing | Michigan | 48910 | — |
| SUNY Health Science Center at Brooklyn | Brooklyn | New York | — | — |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | — |
| Hospital for Special Surgey | New York | New York | 10021 | — |
| Research Site | New York | New York | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| University of Cincinnati Medical Center, Division of Immunology | Cincinnati | Ohio | — | — |
| Research Site | Temple | Texas | — | — |
| Virginia Mason Medical Center | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00624338, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 14, 2016 · Synced Nov 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00624338 live on ClinicalTrials.gov.