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Immune-Mediated Pathophysiology And Clinical Triage Program

Study acronym: IMPACT 2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 18, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Jul 2025 to Jul 2026
    • Study completion date: Jul 2028 to Jul 2029
    v7
  2. Minor 2 versions Re-verified since Jan 26, 2024, no change to tracked fieldsv5-v6
  3. Notable Start date: Jul 29, 2021 to Sep 16, 2021v4
  4. Minor Eligibility criteria expanded, about 16 wordsv3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jul 2022 to Jul 2025
    • Start date changed from estimate of Jul 2020 to Jul 29, 2021
    • Study completion date: Jul 2024 to Jul 2028
    • Study site revised
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Many people develop joint pain, stiffness and swelling due to their cancer treatment that targets the immune system. The severity of symptoms ranges from mild to debilitating and sometimes requires delaying or stopping cancer treatment. The usual plan is to discontinue cancer treatment and give relatively high doses of a medication called prednisone (a steroid, which is an anti-inflammatory medication which may suppress the immune system) with a gradual lowering of the dose over several weeks. While this can be effective, prednisone can cause a number of side effects, and it is not known if this is the best or safest treatment. Hydroxychloroquine is a medication that is often used to treat inflammatory joint pain, such as rheumatoid arthritis, has relatively few side effects when compared to prednisone, and may be effective at treating this condition. The purpose of this study is to find out whether it is better to receive hydroxychloroquine and prednisone, or prednisone alone for joint pain. To do this, some participants will get hydroxychloroquine and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable. This is a double-blinded study, which means that neither participants nor the study doctor or study staff will know which group participants are allocated. After 12 weeks of study treatment, the blind will be opened and participants will be informed which treatment was given.
Trial Details
NCT Number NCT04354649
Lead Sponsor AHS Cancer Control Alberta
Conditions
(from sponsor)
Arthritis, Arthralgia
Related terms Arthralgia, Arthritis
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov