Phase 2 N=10 Randomized Triple-blind Treatment

A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

Scleroderma, Diffuse · Scleroderma, Systemic

Bottom Line

View on ClinicalTrials.gov: NCT00442611 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Apr 2015

Primary outcome: Primary: Change in Modified Rodnan Skin Score — -8.6; -2.3 MRSS score

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Abatacept (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Modified Rodnan Skin Score	-8.6; -2.3	—
SECONDARY Oral Aperture at Baseline and Month 6	31.1; 21.0; 29.4; 21.0; 30.9; 20.0	—
SECONDARY Hand Extension at Baseline and Month 6	177.7; 98.3; 178.9; 103.3; 183.7; 110.7	—
SECONDARY Digital Ulcerations at Baseline and Month 6	0.3; 0.7; 0.1; 1.3; 0.0; 0.7	—
SECONDARY Change in Pulmonary Function Tests	1.3; .3; 2.0; -7.4	—
SECONDARY Change in Scleroderma Health Assessment Questionnaire	-0.04; .25	—

Summary

Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options. We hypothesize that treatment with abatacept, a new therapy recently approved for the treatment of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people with scleroderma.

Eligibility Criteria

Inclusion Criteria

Diagnosis of diffuse systemic sclerosis
age 18 years or older
Adequate renal, pulmonary, and cardiovascular function
Willingness to use effective contraception for the duration of the study if subject is of childbearing potential

Exclusion Criteria

Other connective tissues diseases or overlap syndromes including MCTD, SLE, RA, eosinophilic fasciitis, and limited systemic sclerosis or morphea
Use of disease modifying agents including methotrexate, cyclosporine,azathioprine, mycophenolate mofetil, minocycline, doxycycline, minocycline, thalidomide, penicillamine, tamoxifen, colchicine, or investigational agent within 90 days of screening visit
HIV, Hepatitis B or Hepatitis C infection
use of prednisone greater than 10mg daily for 28 days prior to screening visit
women who are breastfeeding or pregnant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00442611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.