Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Tufts Medical Center
- Study ID
- NCT03159936
- Phase
- EARLY_PHASE1
- Status
- Terminated
Conditions
- Discoid Lupus Erythematosus
- Systemic Lupus Erythematosus
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tofacitinib citrate — BIOLOGICAL10 mg daily by mouth
Study Details
Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent SLE.
Key Dates
- Start date
- Apr 3, 2017
- Status verified
- Jan 2022
- Primary completion
- May 13, 2020
- Completion
- Jun 10, 2020
Study Design
- Enrollment
- 5 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Tofacitinib citrateAll participants will take one 5 mg tablet by mouth in the morning and one tablet by mouth in the evening for the 6-month study duration.
Primary Outcome Measure
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [ Time Frame: week 24 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | - |
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