drugset / Trial / NCT06037811

Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis

NCT06037811

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will examine the effectiveness of administering adalimumab as a treatment for patients in the early stages of steroid-dependent immune checkpoint Inhibitor associated inflammatory arthritis (ir-IA). Adalimumab (ADA) is a TNF inhibitor (TNFi) that is well established as a standard of care treatment for numerous types of inflammatory arthritis. It is hoped that adalimumab at the early stages of the ir-IA will reduce the symptoms and therefore reduce the need for steroids. This study is a pragmatic randomized clinical trial. Patients will be randomized 1:1 to each treatment group. To evaluate the steroid sparing effect of early induction six doses of Adalimumab will be administered to patients in the study treatment arm as compared to the usual standard of care of a predefined corticosteroid regimen and taper at 12 weeks administered in the control group.

Timeline

Start
2024-04-15
Primary completion
2027-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Prednisone Other / unclassified 10 mg Oral
Comparator Prednisone Other / unclassified 20 mg Oral
Comparator Prednisone Other / unclassified 30 mg Oral
Comparator Prednisone Other / unclassified 40 mg Oral
Comparator Prednisone Other / unclassified 50 mg Oral
Comparator Prednisone Other / unclassified 60 mg Oral