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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will be randomized 1:1 (non-blinded) to receive either adalimumab (40 mg subcutaneous every 2 weeks for 12 weeks) and prednisone vs prednisone alone. Addition of methotrexate (MTX) and/or hydroxychloroquine (HCQ) is permitted, as needed, at the discretion of the treating rheumatologist. No additional conventional synthetic, targeted synthetic or biologic DMARDs are permitted during the trial.
Prednisone as per standard of care. The 12-week glucocorticoid regimen and taper will be standardized between the groups. At Baseline, all participants will be switched to oral prednisone dose at 10, 20, 30, 40, 50, or 60 mg once daily. The initial dose of prednisone is at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 10 mg once daily at Baseline. At Baseline, if a participant is on a dose other than 10, 20, 30, 40, 50, or 60 mg QD, the dose will be rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. The prednisone taper regimen is tailored to each patient based on the starting dose over a 12-week period.
St. Joseph's Health Care
London, Ontario, Canada
RECRUITINGpercentage of participants on prednisone
Definition of success: Thirty percent fewer participants on prednisone in Group 2 vs Group 1.
Time frame: at 12 weeks
Cumulative prednisone dose
Definition of success: Thirty percent reduction in the cumulative dose of steroids in Group 2 compared to Group 1.
Time frame: at 12 weeks
percentage of participants on prednisone
Definition of success: Thirty percent difference between the two groups
Time frame: 24 weeks
Cumulative prednisone dose
Definition of success: Thirty percent difference between the two groups
Time frame: 24 weeks
percentage of dose reduction of prednisone
Definition of success: Thirty percent difference between the two groups
Time frame: At 12 and 24 weeks
percentage of participants with immune-related inflammatory arthritis in remission (based on opinion of investigator)
Definition of success: Thirty percent difference between the two groups
Time frame: at 12 and 24 weeks
percentage of participants with immune-related inflammatory arthritis resolution (based on opinion of investigator)
Definition of success: Thirty percent difference between the two groups
Time frame: at 12 and 24 weeks
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