Early Use of Adalimumab to Treat Steroid-Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis in Adults A Phase 2 Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating adalimumab as a treatment for patients in the early stages of steroid-dependent immune checkpoint inhibitor associated inflammatory arthritis ir-IA. This pragmatic randomized clinical trial aims to see if early use of adalimumab can reduce symptoms and the need for steroids compared to the usual corticosteroid treatment. Adalimumab is a TNF inhibitor commonly used for various inflammatory arthritis types and is being tested here for its steroid-sparing effect in ir-IA. Participants will be randomly assigned to one of two groups. One group will receive standard care with a predefined oral prednisone regimen tapered over 12 weeks. The other group will receive six doses of adalimumab 40 mg subcutaneously every 2 weeks alongside the same prednisone taper. Additional medications like methotrexate or hydroxychloroquine may be added if needed but no other disease-modifying drugs are allowed during the trial. During the study, participants will have their prednisone use monitored at 12 and 24 weeks to measure both the percentage still taking prednisone and the total prednisone dose. Researchers will also assess arthritis remission and resolution based on clinical opinion. The study includes regular follow-up visits to evaluate disease control and treatment effects. Participation lasts through the 24-week evaluation period, with safety and treatment monitoring throughout.

Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis