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NCT03844061 · ClinicalTrials.gov registry record · Phase 2
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
A Phase 2 study of Systemic Sclerosis, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03844061 is a Phase 2 study of Systemic Sclerosis that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 30 participants, below the 278-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03844061, a Phase 2 study of Systemic Sclerosis, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 52 week, single center, randomized, double-blind, placebo-controlled study. After patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either Belimumab \& Rituximab or placebo.Patients in both groups will be on background MMF for the entirety of the study. Belimumab will be administered subcutaneously and Rituximab intravenously. Placebo injections and infusions will be of normal saline. Randomization will be done in a 2:1 manner to favor the treatment group. It is hypothesized that that Rituximab and Belimumab combination therapy with Mycophenolate Mofetil background therapy will improve fibrosis in SSc skin when compared to treatment with placebo and Mycophenolate Mofetil in a group of patients with early dcSSc.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Belimumab
- OTHER Placebo Subcutaneous Injection
- OTHER Placebo Infusion
- DRUG MMF
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03844061
The ClinicalTrials.gov registry entry for NCT03844061 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 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 (89% 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 5 interventions - of which Rituximab is the first listed.
NCT03844061 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03844061 about?
NCT03844061 is a clinical study titled "Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis". This is a 52 week, single center, randomized, double-blind, placebo-controlled study. After patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either Belimumab \& Rituximab or placebo.Patients in both groups will be on back...
What is the current status of trial NCT03844061?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-07-29. Estimated completion is 2026-06-30.
What conditions does trial NCT03844061 study?
This clinical trial studies the following conditions: Systemic Sclerosis.
What interventions are being tested in trial NCT03844061?
The interventions under investigation include: Rituximab (DRUG), Belimumab (DRUG), Placebo Subcutaneous Injection (OTHER), Placebo Infusion (OTHER), MMF (DRUG).
Who is sponsoring clinical trial NCT03844061?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03844061 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
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