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NCT02161406 · ClinicalTrials.gov registry record · Phase 2
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
A Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, sponsored by Dinesh Khanna, MD, MS.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 20
- Study locations
NCT02161406: Completed Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, sponsored by Dinesh Khanna, MD, MS.
NCT02161406 is a Phase 2 study of Diffuse Cutaneous Systemic Sclerosis that has completed, run by Dinesh Khanna, MD, MS. The registered enrollment target is 88 participants, roughly in line with the 90-participant average among 6 other Diffuse Cutaneous Systemic Sclerosis trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02161406, a Phase 2 study of Diffuse Cutaneous Systemic Sclerosis, has completed, sponsored by Dinesh Khanna, MD, MS.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score \[mRSS\]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
Primary Outcome
Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Abatacept
Study Locations (20)
New York
- Steffens Scleroderma Center - Albany
- NorthWell Health - Great Neck
- Hospital for Special Surgery - New York
- Columbia University - New York
California
- Arthritis Associates of Southern California - Los Angeles
- University of California- Los Angeles - Los Angeles
- Stanford University - Redwood City
Massachusetts
- Harvard Mass General - Boston
- Boston University - Boston
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University Medical Center - Columbus
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
District of Columbia
- Georgetown University - Washington D.C.
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2014-09 |
| Est. Completion | 2018-10-17 |
| Phase | Phase 2 |
What the finished NCT02161406 record still lists
NCT02161406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, roughly in line with the 90-participant average among 6 other Diffuse Cutaneous Systemic Sclerosis trials with a reported enrollment target.
The record links to 1 condition, with Diffuse Cutaneous Systemic Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02161406 names 20 study sites across 11 states, led by New York, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02161406 about?
NCT02161406 is a clinical study titled "A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis". The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score \[mRSS\]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
What is the current status of trial NCT02161406?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2014-09. Estimated completion is 2018-10-17.
What conditions does trial NCT02161406 study?
This clinical trial studies the following conditions: Diffuse Cutaneous Systemic Sclerosis.
What interventions are being tested in trial NCT02161406?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT02161406?
This trial is sponsored by Dinesh Khanna, MD, MS, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02161406 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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