Eliza Chakravarty
A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Abatacept
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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
Additional Study Details
Official Title:
A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic SclerosisAnticipated start date:
Lead Sponsor:
Stanford UniversityCollaborator(s):
- Bristol-Myers Squibb
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Change in modified Rodnan Skin Score
Secondary Outcomes:
- Change in oral aperture and hand extension
- Change in Pulmonary Function Tests
- Change in digital ulcerations
- Scleroderma Health Assessment Questionnaire
- Change in serum autoantibody profile
- Change in serum cytokine profile
Total Number to be Enrolled:
12Total Number to be Enrolled at Stanford:
12More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/27/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help