Actively Recruiting
Early Adalimumab Induction for Treatment of Steroid Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial
Led by Tom Appleton · Updated on 2026-03-03
30
Participants Needed
1
Research Sites
52 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
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.
CONDITIONS
Brief Title
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older
- New inflammatory arthritis within the last 6 months confirmed by swollen joints, tenosynovitis, or enthesitis
- Arthritis started during or within 4 weeks of stopping immune checkpoint inhibitor therapy
- Immune checkpoint inhibitor therapy started before arthritis onset
- Glucocorticoid dependence defined by prednisone use of at least 10 mg daily or failed steroid taper
- Negative tuberculosis test within 12 months or confirmed within 6 months if receiving adalimumab
- Provided written informed consent
You will not qualify if you...
- Previous diagnosis of inflammatory arthritis or other rheumatic diseases before the current episode
- Tenosynovitis, synovitis, or enthesitis caused by other conditions, fracture, or acute gout/CPPD flare
- Contraindications to adalimumab including recent positive tuberculosis test or untreated infections
- History of congestive heart failure
- Personal or family history of demyelinating neurologic disease
- Previous use of TNF inhibitors
- Current use of other disease-modifying agents like chloroquine or azathioprine
- Recent systemic immunosuppression for other immune-related adverse events
- Chronic steroid use for reasons other than immune-related arthritis
- Pregnancy, breastfeeding, or childbearing potential without effective contraception
- Inability to participate in follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either adalimumab injections every 2 weeks plus a prednisone taper or prednisone taper alone to treat immune checkpoint inhibitor associated inflammatory arthritis.
6 visits for adalimumab injections every 2 weeks plus weekly prednisone taper visits or weekly prednisone taper visits alone
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
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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