MedTrace Logo

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

NCT02161406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-02-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Diffuse Cutaneous Systemic Sclerosis

Interventions

DRUG

Abatacept

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

DRUG

Placebo

125 mg of Placebo

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Dinesh Khanna, MD, MS

    lead OTHER

Principal Investigators

  • Dinesh Khanna, MD, MS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-09-12
Completion
2018-10-17
FDA Drug
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161406 on ClinicalTrials.gov