CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
Abatacept +1 moredrug
Likely dose
Abatacept 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02161406
NCT02161406Phase 2Completed
CompareCT.gov

A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.

Dinesh Khanna, MD, MS·interventional·Posted Jun 11, 2014·Updated Feb 17, 2020

In Brief

A Phase 2 clinical trial evaluating Abatacept and Placebo for Diffuse Cutaneous Systemic Sclerosis. Completed, enrolled 88 participants across 27 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Cutaneous Systemic Sclerosis
CountriesCanada, United Kingdom, United States
CollaboratorsBristol-Myers Squibb, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 11, 2014
Enrollment StartSep 1, 2014
Primary CompletionSep 12, 2018
Study CompletionOct 17, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 12.1 years ago

Interventions

Abataceptdrug

Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

Placebodrug

125 mg of Placebo