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NCT02270957 · ClinicalTrials.gov registry record · Phase 2
Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
A Phase 2 study, sponsored by Oklahoma Medical Research Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT02270957: Completed Phase 2 study, sponsored by Oklahoma Medical Research Foundation.
NCT02270957 is a Phase 2 study that has completed, run by Oklahoma Medical Research Foundation. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02270957, a Phase 2 study, has completed, sponsored by Oklahoma Medical Research Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo controlled trial of abatacept for the treatment of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3 tender and 3 swollen joints and \</= 20 mg prednisone have other background immune suppressants withdrawn at entry. They can elect to receive up to a total of 320 mg depomedrol (in two or more injections) between the screening visit and the visit 2 months after dosing begins. Abatacept (125 mg) or placebo is administered in weekly subcutaneous doses. After 3 months of treatment patients who are not responding may elect to receive open label abatacept with or without additional standard of care therapies. Such patients are considered non responders. The primary endpoint is the British Isles Lupus Assessment Group Index (BILAG)-linked Combined Lupus Assessment (BICLA) which will require a clinically significant improvement in arthritis and other active features of lupus
Primary Outcome
The British Isles Lupus Assessment Group Index is a scoring system for progress of disease activity over the prior month with a scoring system that rates each organ system as "A" or severe, "B" or moderate, "C" or mild vs no activity in the past month. To meet the BICLA endpoint requires all baseline severe features (BILAG A) improving to moderate (BILAG B), mild or resolved, and all baseline BILAG B features improving to mild or resolved without increase in any other feature on either the BILAG
Interventions
- OTHER Placebo
- BIOLOGICAL Abatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-01 |
| Est. Completion | 2021-12 |
| Phase | Phase 2 |
What the finished NCT02270957 record still lists
NCT02270957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02270957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02270957 about?
NCT02270957 is a clinical study titled "Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches". This is a randomized, double blind, placebo controlled trial of abatacept for the treatment of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3 tender and 3 swollen joints and \</= 20 mg prednisone have other background immune suppressants withdrawn at entry. The...
What is the current status of trial NCT02270957?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2014-01. Estimated completion is 2021-12.
What interventions are being tested in trial NCT02270957?
The interventions under investigation include: Placebo (OTHER), Abatacept (BIOLOGICAL).
Who is sponsoring clinical trial NCT02270957?
This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02270957's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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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