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NCT01670565 · ClinicalTrials.gov registry record · Phase 2
Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis
A Phase 2 study of Systemic Sclerosis, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01670565: Completed Phase 2 study of Systemic Sclerosis, sponsored by Hospital for Special Surgery, New York.
NCT01670565 is a Phase 2 study of Systemic Sclerosis that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 20 participants, below the 278-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01670565, a Phase 2 study of Systemic Sclerosis, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity measured by an improvement in skin thickening and stability of pulmonary function test measurements when compared to patients treated with placebo/MMF.
Primary Outcome
Change in MRSS is measured by median change (and interquartile range) from Baseline median to week 52 median. The efficacy of the drug will be measured as the change in the Modified Rodnan Skin Score (MRSS) at 52 weeks. The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is 0 for uninvolved skin through 3 for severe thickening
Conditions Studied
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Belimumab
- OTHER Placebo Infusion
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01670565 record still lists
NCT01670565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 278-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Systemic Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Mycophenolate Mofetil is the first listed.
NCT01670565 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01670565 about?
NCT01670565 is a clinical study titled "Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis". This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a beli...
What is the current status of trial NCT01670565?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2012-08. Estimated completion is 2016-02.
What conditions does trial NCT01670565 study?
This clinical trial studies the following conditions: Systemic Sclerosis.
What interventions are being tested in trial NCT01670565?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Belimumab (DRUG), Placebo Infusion (OTHER).
Who is sponsoring clinical trial NCT01670565?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01670565 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01670565's enrollment target sits among peer trials
20 21st of 26 higher than 5 of 26 other Systemic Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis 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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