Using Adalimumab to treat early inflammatory arthritis caused by immune checkpoint inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.