Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03844061 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Jun 30, 2026 → Aug 30, 2027
See other at-risk trials from Hospital for Special Surgery, New York

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 30, 2026 to Aug 30, 2027 Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 30, 2026 to Dec 30, 2027
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 13 of 18 entries
    • Site details revised
    • Study description expanded, about 3 words
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2026v12
  3. 2 versions Re-verified since Feb 28, 2024, no change to tracked fieldsv10-v11
  4. Primary completion date: Dec 17, 2023 to Jun 30, 2025v9 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Study completion date: Dec 17, 2024 to Jun 30, 2026
    • Secondary endpoints revised (18)
    • Site contact updated
  5. Primary completion date: Jun 30, 2023 to Dec 17, 2023
    • Study completion date: Jun 30, 2024 to Dec 17, 2024
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Jun 30, 2022 to Jun 30, 2023
    • Study completion date: Jun 30, 2022 to Jun 30, 2024
    v7
  2. Primary and study completion dates: Feb 28, 2022 to Jun 30, 2022v6
  3. 2 versions Re-verified since Sep 15, 2020, no change to tracked fieldsv4-v5
  4. Start date changed from estimate of May 19, 2019 to Jul 29, 2019v3
  5. Start date: Feb 19, 2019 to May 19, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03844061
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: GlaxoSmithKline
Conditions
(from sponsor)		 Systemic Sclerosis
Related terms Scleroderma, Systemic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov