NCT06001125

Methotrexate for Immune Related Arthritis or Arthralgias (IMPACT 2.1)

A Study to Evaluate the Efficacy and Safety of Methotrexate in Immune Related Arthritis or Arthralgias

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Arthritis
• Arthralgia

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate 20 mg PO weekly

Timeline

• Start date: 2024-08-12
• Primary completion: 2025-06-17
• Completion: 2025-10-07
• First posted: 2023-08-21
• Last updated: 2026-01-06

Locations

1 site across 1 country: Canada