Completed

Mechanisms of Antifolate Efficacy in Arthritis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Methotrexate

+ Folinic acid

+ Methotrexate

DrugDietary Supplement
Who is being recruted

Arthritis+7

+ Connective Tissue Diseases

+ Immune System Diseases

From 18 to 85 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: September 1996
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: December 16, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1996

Actual date on which the first participant was enrolled.

Low-dose methotrexate therapy suppresses autoimmune arthritis in human and animal models. We hypothesize that the effect of methotrexate in the treatment of rheumatoid arthritis is due to the inhibition of aminoimidazole-carboxamide ribotide transformylase, a folate-dependent enzyme that catalyzes the last step in the de novo biosynthesis of inosine monophosphate. The resulting accumulation of aminoimidazole carboxamide riboside inhibits adenosine deaminase, therefore interfering with normal adenosine metabolism. It is well known that children with adenosine deaminase deficiency have severe combined immunodeficiency syndrome. This suggests that adenosine deaminase activity is key to immune competence and is associated with the mechanism of efficacy in methotrexate therapy of rheumatoid arthritis. Several studies indicate that supplemental folinic acid (5-formyltetrahydrofolate) used in large doses during low-dose methotrexate therapy for rheumatoid arthritis causes a flare in joint inflammation. However, supplemental folic acid (pteroylglutamic acid) does not lessen the efficacy of the therapy. We further hypothesize that if methotrexate efficacy is driven by aminoimidazole carboxamide ribotide transformylase inhibition, folic acid supplementation should not alter urinary levels of aminoimidazole carboxamide, adenosine, and deoxyadenosine, while folinic acid supplementation should prevent the accumulation of these compounds. We will test our hypotheses both in people with rheumatoid arthritis and in Lewis rat adjuvant arthritis. Our objectives include: (1) determining if the dose level of methotrexate that is clinically optimal in the treatment of Lewis rat adjuvant arthritis interferes with normal adenosine metabolism; (2) determining the effectiveness of drugs that interfere with adenosine metabolism (deoxycoformycin, aminoimidazole carboxamide, and aminoimidazole carboxamide with a suboptimal dose of methotrexate) in Lewis rat adjuvant arthritis; and (3) determining whether supplemental folic acid and folinic acid during methotrexate therapy normalize adenosine metabolism in patients with rheumatoid arthritis. The information we obtain will enhance the understanding of the biochemical action of antifolates/antimetabolites that are effective in the treatment of human and animal arthritis.

NCT00000395
Principal SponsorUniversity of Alabama at Birmingham
Last updated: December 16, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesArthritis, ExperimentalArthritis, RheumatoidAutoimmune Diseases

Criteria

2 inclusion criteria required to participate
Individuals starting methotrexate for rheumatoid arthritis

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

2 exclusion criteria prevent from participating
Cancer, renal, or liver disease

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects receiving Methotrexate for 6 weeks and 5 mg of Folinic acid daily for 1 week.

Group II

Experimental
Subjects receiving Methotrexate for 6 weeks and 5 mg of Folic acid daily for 1 week.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The University of Alabama at Birmingham

Birmingham, United StatesOpen The University of Alabama at Birmingham in Google Maps
CompletedOne Study Center