MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE

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.

Timeline

Start

2017-04-10

Primary completion

2022-02-16

Completion

2022-12-16

Outcome

Outcome not reported

Stopped (Enrollment): “poor recruitment, funding”

Drugs

Indications