NCT03355482

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Oklahoma Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a six month, double blind, randomized, placebo- controlled trial of subcutaneous methotrexate vs methotrexate plus baseline Depomedrol in patients with SLE and \>/= 3 tender and 3 swollen joints in the hands and wrists. Patients who are already taking methotrexate \</= 15 mg/week may qualify and will have a \>/= 2.5 mg/week dose increase at baseline, receiving subcutaneous dosing whether on oral or sc dosing prior to entry. Those not taking methotrexate at baseline will initiate open label treatment in ascending doses beginning at 15 mg/week. All patients will increase methotrexate weekly up to 25 mg as tolerated or until resolution of arthritis. Decreases are allowed as needed. After randomization, patients may choose to stop or continue any NSAIDs, hydroxychloroquine, or up to 10 mg prednisone if these were being used at screening. All other lupus-specific treatments or medications will be withdrawn. Optimization of methotrexate dose must be completed by Month 2. If additional immune- suppressive medications or steroids become necessary during the trial, patients remain evaluable for the primary endpoint, which is defined by clinical response regardless of treatment. In secondary analyses of Depomedrol vs. placebo, patients treated with rescue interventions will be censored when comparing changes in mean/median synovitis, osteitis RAMRIS or tendinitis scores in the two treatment groups, and they will be included as non- responders in dichotomous endpoints (SRI-4, BICLA). These analyses will also provide useful data for many of the other endpoints (comparisons of MRI vs joint counts and other measures which are valid regardless of treatment). Thus, although off protocol medications will not be encouraged, they will not require removal from the study.

Conditions

• Systemic Lupus Erythematosus Arthritis

Interventions

Type	Name	Description
DRUG	Methylprednisolone	160mg IM at baseline
DRUG	Placebos	IM saline injection at baseline

Timeline

• Start date: 2017-04-10
• Primary completion: 2022-02-16
• Completion: 2022-12-16
• First posted: 2017-11-28
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study