Using Adalimumab to treat early inflammatory arthritis caused by immune checkpoint inhibitors
Early Adalimumab Induction for Treatment of Steroid Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial
This study is testing if adalimumab can help people with early inflammatory arthritis caused by cancer treatments to feel better and rely less on steroids.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | adalimumab, prednisone |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06037811 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adalimumab, a TNF-alpha inhibitor, for patients experiencing early steroid-dependent inflammatory arthritis associated with immune checkpoint inhibitors. Participants will be randomized into two groups: one receiving six doses of adalimumab and the other following a standard corticosteroid regimen. The goal is to evaluate whether early treatment with adalimumab can alleviate symptoms and reduce the reliance on steroids. The study aims to provide insights into the steroid-sparing effects of adalimumab in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with new inflammatory arthritis that developed during or shortly after immune checkpoint inhibitor therapy.
Not a fit: Patients whose inflammatory arthritis fully responds to low doses of prednisone or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for steroids in patients with inflammatory arthritis linked to immune checkpoint inhibitors.
How similar studies have performed: Other studies have shown promise in using TNF inhibitors for inflammatory arthritis, suggesting that this approach may be beneficial, though this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • 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 * Glucocorticoid dependence at any time before enrolment, defined by either: * Patients requiring prednisone at a dose of at least 10 mg daily (or equivalent) OR * Patients for whom at least 1 glucocorticoid taper failed to control the disease activity * 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 Criteria: * 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
Where this trial is running
London, Ontario
- St. Joseph's Health Care — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Tom Appleton, MD, PhD, FRCPC
- Email: tom.appelton@sjhc.london.on.ca
- Phone: 519-646-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.