Status:
RECRUITING
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
Lead Sponsor:
Tom Appleton
Collaborating Sponsors:
Canadian Research Group in Immuno-Oncology
Western University
Conditions:
Inflammatory Arthritis
Immune-related Adverse Event
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- • Patients are deemed eligible for study participation if they meet all the following:
- Adult patients (age 18 or older)
- New (within the last 6 months prior to enrollment) inflammatory arthritis defined by any of the following at the time of screening (either on physical exam or by ultrasound) by a certified rheumatologist:
- 1 or more swollen joints OR
- 1 or more tenosynovitis OR
- 1 or more enthesitis
- Arthritis onset with taking ICI therapy OR within 4 weeks of stopping ICI therapy including CTLA-4, PD-1, and PDL-1 inhibitors
- Initiation of ICI therapy must predate the onset of inflammatory arthritis
- Arthritis either does not respond completely to prednisone doses of 10mg (equivalent) OR recurs with prednisone taper below 10mg daily.
- Negative tuberculosis (TB) status within the past 12 months (TB skin test or quantiferon) for the patients in the adalimumab group. If not available, the status should be confirmed within 6 months of enrollment in the study (adalimumab group only)
- Written informed consent provided by patient or power of attorney
Exclusion
- Patients are excluded if they meet any of the following:
- 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
- Any of the following in the 7 days prior to initiation of adalimumab: positive tuberculin skin test (\>5mm induration within 48 to 72 hours) or positive quantiferon, evidence of untreated active infection including fungal infection, opportunistic infection, hepatitis B/C, or HIV
- Personal history of congestive heart failure
- Personal or family history of demyelinating neurologic disease
- History of previous TNF inhibitor use
- Current use of other disease modifying agents including: Chloroquine, Sulfasalazine, Azathioprine, 6-MP, and Leflunomide
- Presence of a concomitant non-rheumatic irAE which required systemic immunosuppression within the past 3 months e.g. pneumonitis, hepatitis, colitis, scleritis, nephritis
- Require chronic steroid treatment for adrenal insufficiency or another medical reason other than ir-IA
- Pregnancy, breastfeeding or childbearing potential without practicing highly effective contraception.
- Inability to participate in follow-up visits
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06037811
Start Date
April 15 2024
End Date
November 1 2025
Last Update
October 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2