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NCT01946880 · ClinicalTrials.gov registry record · Phase 2
Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT01946880: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01946880 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01946880, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
Primary Outcome
Disease reactivation requires:1) SELENA-SLEDAI mild/moderate or severe flare,and 2) Increased immunosuppressive therapy on a sustained basis,defined by one of the following criteria:a) Sustained activity:Significant prolonged SLE flare requiring steroid increase/burst to ≥15 mg/day prednisone (or equivalent) for \>4 weeks.b) Frequent relapsing/remitting:Participant flares requiring an increase/burst of steroids and is successfully tapered to \<15 mg/day within 4 weeks, but this occurs on \>2 occ
Interventions
- DRUG Prednisone
- DRUG Mycophenolate Mofetil
- DRUG Hydroxychloroquine or Chloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2013-11-20 |
| Est. Completion | 2019-07-03 |
| Phase | Phase 2 |
Why NCT01946880 stopped before completion
NCT01946880 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01946880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01946880 about?
NCT01946880 is a clinical study titled "Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)". This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
What is the current status of trial NCT01946880?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2013-11-20. Estimated completion is 2019-07-03.
What interventions are being tested in trial NCT01946880?
The interventions under investigation include: Prednisone (DRUG), Mycophenolate Mofetil (DRUG), Hydroxychloroquine or Chloroquine (DRUG).
Who is sponsoring clinical trial NCT01946880?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01946880's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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