Clinical Trial: A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: This study is a randomized placebo-controlled double-blind phase 2 trial of patients with dcSSc. Eligible participants will be randomized in a 1:1 ratio to either 125 mg SC abatacept or matching placebo, stratified by duration of dcSSc disease duration (<18 months vs >18 to </=36 months). Study participants will be treated for 12 months on double-blind study medication, followed by an additional 24 weeks of open-label SC abatacept therapy. 86 patients will be randomized in approximately 35 centers in the US, Canada and Europe, with the goal of analyzing 74 participants. The investigators study will test whether abatacept is statistically superior to placebo in reducing the MRSS at month 12 and explore the ability of abatacept to prevent or reverse progression in patients with early disease duration and lower MRSS scores, and reverse established disease in patients with longer disease duration and higher MRSS scores.
Sponsor: Dinesh Khanna, MD, MS

Current Primary Outcome:

  • Incidence of adverse events (AEs) and Serious AEs (SAEs) [ Time Frame: 52 weeks ]
    Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs
  • Change from baseline in the modified Rodnan skin score (mRSS) to month 12 [ Time Frame: Baseline and 52 weeks ]
    The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Positive or negative change on 28- tender/swollen joint counts [ Time Frame: Baseline and 52 weeks ]
  • Change in subject reported outcomes [ Time Frame: Baseline and 52 weeks ]
    Quality of life questionaires will be used to capture this data.
  • Change in % predicted FVC [ Time Frame: Baseline and 52 weeks ]


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: June 3, 2014
Date Started: September 2014
Date Completion: February 2019
Last Updated: March 9, 2017
Last Verified: March 2017