Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001125
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-08-04
Brief Title:
Methotrexate for Immune Related Arthritis or Arthralgias IMPACT 21
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
A Study to Evaluate the Efficacy and Safety of Methotrexate in Immune Related Arthritis or Arthralgias
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 20 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 20 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 20 that dont 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
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 20 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 20 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 20 that dont 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None