Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTom Appleton

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients (age 18 or older)

1 or more swollen joints OR

1 or more tenosynovitis OR

1 or more enthesitis

Disqualifiers

Previous diagnosis of inflammatory arthritis or other rheumatic disease (prior to current acute episode)

Including but not limited to: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic vasculitis, undifferentiated inflammatory arthritis, undifferentiated connective tissue disease

Tenosynovitis, synovitis or enthesitis attributed to another cause, fracture or acute gout/CPPD flare.

Presence of a contraindication to adalimumab therapy

Trial design

Treatments tested in this trial

  • Adalimumab
  • Prednisone

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tom Appleton

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

Canadian Research Group in Immuno-Oncology

Collaborator

Western University

Collaborator