MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is an exploratory evaluation of MRI as a reliable, sensitive, and accurate outcome
measure for clinical trials in SLE arthritis. Forty patients with SLE and moderate to severe
synovitis (minimum of 3 tender and 3 swollen joints in wrists and hands) will be randomized
to new or increased methotrexate therapy plus a single injection of Depomedrol or a matched
placebo at baseline. Methotrexate will be injected subcutaneously once per week at ascending
doses. The study will evaluate a range of outcomes discernable by MRI at 3 months and 6
months after baseline. We will also compare MRI findings, clinical endpoints, and biomarker
changes in patients that were treated with Depomedrol vs. matched placebo at baseline.