Eliza Chakravarty
Safety and Efficacy of Abatacept for Scleroderma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
evaluate the safety (possible side effect) and the effectiveness (response) of the investigational drug abatacept, as a possible treatment for diffuse systemic sclerosis. Systemic sclerosis (scleroderma) is an anutoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: abatacept
Phase:
Phase 1Eligibility
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:
Male and Female 18 and older
Diagnosis of diffuse systemic sclerosis
Adequate ernal, pulmonary, cardiovascular function
Use of effective contraception for duration of study
Key Exclusion Criteria:
Other connective tissue diseases or overlap syndromes including MCTD, SLE, RA, eosinophilic fascilitis, limited systemic sclerosis or morphea
Use of disease modifying agents including methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, minocycline, doxycycline, minocycline, thalidomide, penicillamine, tamoxifen, colchincine, or inestigational agent within 90 days of screening
HIV, Hepatitis B or Hepatitis C infection
Use of prednisone greater than 10mg daily for 28 days prior to screening
Women who are pregnant or breast feeding
Additional Study Details
Official Title:
Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients with Diffuse Systemic SclerosisAnticipated start date:
2/1/2007Lead Sponsor:
Bristol Myers SqiubbInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- change in ROdnan skin score
Secondary Outcomes:
- Change in oral aperture and hand extension
- change in pulmonary function tests
- change in digital ulcerations
- 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:
11/26/2007PLEASE 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.
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