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Methotrexate for Immune Related Arthritis or Arthralgias (IMPACT 2.1)

NCT06001125 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-01-06

No results posted yet for this study

Summary

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 several side effects, and it is not known if this is the best or safest treatment.

Hydroxychloroquine is a medication being studied on IMPACT 2.0 on participants who develop inflammatory joint pain while taking cancer treatments that affect their immune system. It is possible that the hydroxychloroquine treatment may not work well on some participants on IMPACT 2.0. Hydroxychloroquine is also given as standard of care to participants with this type of inflammatory joint pain.

The goal of this study is to learn how well methotrexate is at treating inflammatory joint pain in participants from IMPACT 2.0 that don't do well on treatment with hydroxychloroquine and in patients given hydroxychloroquine as standard of care to treat this type of inflammatory joint pain caused by taking cancer treatments which target their immune system.

Conditions

Interventions

DRUG

Methotrexate

Methotrexate 20 mg PO weekly

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Michael Kolinsky · AHS-CCI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2025-06-17
Completion
2025-10-07

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06001125 on ClinicalTrials.gov