Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Hydroxychloroquine in Immune Related Arthritis or Arthralgias
Led by AHS Cancer Control Alberta · Updated on 2025-06-18
46
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for joint pain, stiffness, and swelling caused by cancer therapies that target the immune system. These symptoms can range from mild to severe and sometimes require stopping cancer treatment. The study aims to compare the effects of hydroxychloroquine combined with prednisone versus prednisone alone to determine which approach may better manage joint pain related to immune therapy side effects. Participants will receive either hydroxychloroquine at a dose of 5 mg per kilogram daily along with prednisone starting at 20 mg daily for 8 weeks with a tapering dose, or a matching placebo with the same prednisone regimen. This is a double-blinded, randomized study where neither participants nor researchers know who is receiving hydroxychloroquine or placebo until after 12 weeks of treatment. After this period, the treatment assignments will be revealed. During the study, participants will be monitored for recurrence of moderate or worse immune-related arthritis or joint pain over about one year. Researchers will track steroid usage, other immune-related side effects, adverse events, and cancer progression. Follow-up will continue for up to three years after treatment to assess long-term outcomes. Participants will have regular assessments to evaluate their condition and treatment effects throughout the study period.
CONDITIONS
Brief Title
Immune-Mediated Pathophysiology And Clinical Triage Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older
- Patients must be able to provide consent for enrollment and treatment
- Patients with a performance status of ECOG 0-2
- Patients with confirmed cancer receiving anti-PD1, anti-PDL1, or anti-CTLA4 immune checkpoint inhibitor therapy who develop grade 2 or higher arthritis or joint pain related to treatment
- Adequate liver and kidney function as defined by specific lab values
- Women of childbearing potential must have a negative pregnancy test at screening
- Patients of reproductive potential must use highly effective birth control during and for 3 months after the study
- Female patients who are breastfeeding must stop nursing before treatment and for 3 months after
- Male patients must agree not to donate sperm during and for 3 months after the study
- No conditions that would prevent following the study protocol and follow-up schedule
You will not qualify if you...
- History of inflammatory arthritis or autoimmune diseases like rheumatoid arthritis, lupus, Sjogren's syndrome, or ankylosing spondylitis
- Need for systemic immunosuppressive medications or corticosteroids, except certain topical or premedication steroids
- Patients with grade 2 or higher immune-related side effects other than arthritis or joint pain (except controlled endocrinopathies)
- Weight less than 40 kilograms
- G6PD deficiency, porphyria, or psoriasis
- Significant active cardiovascular disease or recent stroke or heart attack
- Prolonged QT interval or medications that prolong QT
- Diagnosis of immunodeficiency
- Known severe allergies to the study drug or similar medications
- Other serious acute or chronic medical or psychiatric conditions that increase risk or interfere with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants receive daily oral hydroxychloroquine or matching placebo, along with prednisone starting at 20 mg daily for 8 weeks with a tapering dose.
Weekly visits during prednisone tapering
Duration - Up to 1 year after treatment
Participants are monitored for recurrence of arthritis or arthralgia, adverse events, steroid usage, and response to standard care treatments.
Visits approximately monthly up to 1 year
Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
Research Team
M
Michael Kolinsky
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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