Actively Recruiting
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
Led by Tom Appleton · Updated on 2026-03-03
30
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
T
Tom Appleton
Lead Sponsor
C
Canadian Research Group in Immuno-Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age 18 or older
- New inflammatory arthritis within the last 6 months defined by swollen joints, tenosynovitis, or enthesitis confirmed by a certified rheumatologist
- Arthritis started during immune checkpoint inhibitor therapy or within 4 weeks of stopping it
- Immune checkpoint inhibitor therapy started before arthritis onset
- Glucocorticoid dependence before enrollment, requiring prednisone at least 10 mg daily or having failed at least one glucocorticoid taper
- Negative tuberculosis test in the past 12 months or confirmed within 6 months for patients receiving adalimumab
- Provided written informed consent or consent from power of attorney
You will not qualify if you...
- Previous diagnosis of inflammatory arthritis or other rheumatic diseases before current episode, including rheumatoid arthritis, lupus, systemic sclerosis, Sjogren's syndrome, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic vasculitis, undifferentiated inflammatory arthritis, or connective tissue disease
- Tenosynovitis, synovitis, or enthesitis caused by other reasons, fracture, or acute gout/CPPD flare
- Contraindications to adalimumab, including recent positive tuberculin skin test or quantiferon, untreated active infections, hepatitis B/C, HIV
- History of congestive heart failure
- Personal or family history of demyelinating neurological disease
- Previous use of TNF inhibitors
- Current use of other disease modifying drugs like chloroquine, sulfasalazine, azathioprine, 6-MP, or leflunomide
- Concurrent non-rheumatic immune-related adverse events needing systemic immunosuppression in past 3 months
- Chronic steroid use for adrenal insufficiency or other reasons except ir-IA
- Pregnancy, breastfeeding, or childbearing potential without effective contraception
- Inability to participate in follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Actively Recruiting
Research Team
T
Tom Appleton, MD, PhD, FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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