New hope for cancer patients: drug may cut steroid need for immunotherapy side effect
NCT ID NCT06037811
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug adalimumab can help people with arthritis caused by cancer immunotherapy use less steroids. About 30 adults will be randomly assigned to receive either adalimumab or standard steroid treatment. The goal is to see if adalimumab can control arthritis symptoms and reduce the need for steroids.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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St. Joseph's Health Care
RECRUITINGLondon, Ontario, N6A 4V2, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a light-based blood filter calm immune side effects that steroids can't?
- Can teaching patients about immunotherapy cut severe side effects?
- Can talk therapy plus exercise beat arthritis fatigue?
- Can a Gut-Targeting drug shield cancer patients from Immunotherapy's worst side effect?
- Can a Bone-Sparing hip implant outperform traditional replacement?
- Blood filtering may tame severe immunotherapy side effects