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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01670565
The ClinicalTrials.gov registry entry for NCT01670565 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 278-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (93% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.