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NCT02347891 · ClinicalTrials.gov registry record · Phase 2
Belimumab in Idiopathic Inflammatory Myositis
A Phase 2 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02347891: Completed Phase 2 study, sponsored by Northwell Health.
NCT02347891 is a Phase 2 study that has completed, run by Northwell Health. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02347891, a Phase 2 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care. This is a multicentre double-blind, placebo-controlled trial.
Primary Outcome
Definition of Improvement (DOI) is ≥ 20% of improvement in any 3 of the core set measures (CSM) - Manual Muscle Testing, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra- muscular activity and no more than 2 CSM worsening by ≥ 25% (excluding MMT). Total Improvement Score ( TIS) is a sum of weighted scores of absolute change of core set measures ( MMT, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra-muscluar activity ). The scores range from 0 to 10
Interventions
- DRUG Placebo
- DRUG Belimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-11 |
| Phase | Phase 2 |
What the finished NCT02347891 record still lists
NCT02347891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02347891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02347891 about?
NCT02347891 is a clinical study titled "Belimumab in Idiopathic Inflammatory Myositis". The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care. This is a multicentre double-blind, placebo-controlled trial.
What is the current status of trial NCT02347891?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-01. Estimated completion is 2020-11.
What interventions are being tested in trial NCT02347891?
The interventions under investigation include: Placebo (DRUG), Belimumab (DRUG).
Who is sponsoring clinical trial NCT02347891?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02347891's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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