Completed

Phase 2
Age: 18Years - 85Years
All Genders
ID00000395

Mechanisms of Antifolate Efficacy in Arthritis

Led by University of Alabama at Birmingham · Updated on 2016-12-16

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Antifolate Effectiveness in Arthritis

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals starting methotrexate for rheumatoid arthritis.
  • Study subjects should not currently be taking folic acid-containing vitamins.
Not Eligible

You will not qualify if you...

  • Cancer, renal, or liver disease.
  • Previous use of methotrexate within the past 6 months or current use of folic acid-containing supplements.

Trial Site Locations

Total: 1 location

1

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

The effect of folic acid supplementation on the toxicity of low-dose methotrexate in patients with rheumatoid arthritis.

S L Morgan, J E Baggott, W H Vaughn...

https://pubmed.ncbi.nlm.nih.gov/2405864

Supplementation with folic acid during methotrexate therapy for rheumatoid arthritis. A double-blind, placebo-controlled trial.

S L Morgan, J E Baggott, W H Vaughn...

https://pubmed.ncbi.nlm.nih.gov/7978695

Folic acid supplementation prevents deficient blood folate levels and hyperhomocysteinemia during longterm, low dose methotrexate therapy for rheumatoid arthritis: implications for cardiovascular disease prevention.

S L Morgan, J E Baggott, J Y Lee...

https://pubmed.ncbi.nlm.nih.gov/9517760

The effect of methotrexate and 7-hydroxymethotrexate on rat adjuvant arthritis and on urinary aminoimidazole carboxamide excretion.

J E Baggott, S L Morgan, W J Koopman

https://pubmed.ncbi.nlm.nih.gov/9704638

Guidelines for folate supplementation in rheumatoid arthritis patients treated with methotrexate: comment on the guidelines for monitoring drug therapy.

G S Alarcón, S L Morgan

https://pubmed.ncbi.nlm.nih.gov/9041955