New hope for cancer patients: drug may cut steroid need for immunotherapy side effect

NCT ID NCT06037811

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • St. Joseph's Health Care

    RECRUITING

    London, Ontario, N6A 4V2, Canada

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