Overview

Antifolate Effectiveness in Arthritis

Status:
Completed
Trial end date:
2002-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study looks at how the arthritis drug methotrexate works in low doses to treat rheumatoid arthritis. (High doses of methotrexate are used to treat some types of cancer.) Methotrexate blocks the action of the B-vitamin known as folic acid. We are studying the biochemical reactions affected by this vitamin because we think that blocking many of these reactions may be necessary for methotrexate to work in treating rheumatoid arthritis. Through these studies, we hope to gain a better understanding of how this drug and related drugs work as treatments for arthritis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Treatments:
Folic Acid
Folic Acid Antagonists
Leucovorin
Levoleucovorin
Methotrexate
Vitamin B Complex
Criteria
Inclusion Criteria:

- Individuals starting methotrexate for rheumatoid arthritis.

- Study subjects should not currently be taking folic acid-containing vitamins.

Exclusion Criteria:

- Cancer, renal, or liver disease.

- Previous use of methotrexate within the past 6 months or current use of folic
acid-containing supplements.