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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00442611
• Date of registration: 01/03/2007
• Prospective Registration: Yes
• Primary sponsor: Stanford University
• Public title: A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)
• Scientific title: A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic Sclerosis
• Date of first enrolment: November 2008
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00442611
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Eliza Farmer Chakravarty
• Affiliation: Stanford University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Scleroderma, Systemic

Scleroderma, Diffuse

Intervention(s)

Drug: Placebo

Drug: Abatacept

Primary Outcome(s)

Change in Modified Rodnan Skin Score [Time Frame: 6 months]

Secondary Outcome(s)

Change in Scleroderma Health Assessment Questionnaire [Time Frame: 6 months]

Oral Aperture at Baseline and Month 6 [Time Frame: Baseline; Month 6]

Change in Pulmonary Function Tests [Time Frame: 6 months]

Digital Ulcerations at Baseline and Month 6 [Time Frame: Baseline; Month 6]

Hand Extension at Baseline and Month 6 [Time Frame: Baseline; Month 6]

Secondary ID(s)

100 186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb

Results

• Results available: Yes
• Date Posted: 24/04/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00442611