Title: A phase 2 study to evaluate subcutaneous abatacept vs placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial.
Sponsors: UCLA, Pacific Arthritis Associates (Suzanne Kafaja, Daniel E. Furst) and Bristol-Myers Squibb (BMS)
The UCLA Division of Rheumatology is looking for people with diffuse cutaneous systemic sclerosis (SSc) to participate in a research study.
Diffuse cutaneous systemic sclerosis (SSc)
At least 18 years old
The drug used in this study is subcutaneous abatacept (or placebo), which has not been approved by the FDA for the treatment of SSc. In Part 1 of the study, you will receive treatment with either abatacept or placebo once a week for up to 48 weeks. In Part 2 of the study, every participant will receive abatacept for up to 24 weeks.
The first abatacept (or placebo) injection will be given in the study clinic during the baseline visit. You will be trained to give yourself injections under the skin, so you can perform this at home. You will continue to give yourself an injection of 125 mg. of abatacept (or placebo) once a week up to 48 weeks. If you continue to participate in Part 2, you will continue to receive abatacept once a week up to 24 more weeks.
After the baseline study visit, you will return to the study clinic for 5 more visits at 1,3,6,9 and 12 months. If you continue to participate in Part 2, you will be asked to visit the study clinic for 3 more visits at 14, 16, and 18 months.
If you participate in this study you will be reimbursed $50 for each visit (this amount includes parking fees).
To make an appointment with the study doctor to learn about this study, please contact Jeraldine Guzman at 310-825-4744 (UCLA) or Emma Hasan at 310-297-6812 (Pacific Arthritis Associates).