A study to determine the optimal dose of folic acid supplementation in patients with rheumatic diseases on methotrexate treatment

Phase 2

Recruiting

• Conditions: Patients on methotrexate therapy regularly take folic acid supplementation to prevent its toxicity.; rheumatioid arthritis, psoriatic arthritis, polymyositis, dermatomyositis, ANCA-associated vasculitis; D001172, D015535, D017285, D003882, D056648

• Registration Number: JPRN-jRCT1061230085
• Lead Sponsor: Shintaro Hirata

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-26
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult patients aged 18 years or older at the time of consent
2. Patients who were diagnosed with rheumatic disease more than 12 weeks ago and have been receiving stable doses of methotrexate for more than 8 weeks
3. Patients receiving folic acid 5 mg/week 24-48 hours after the last dose of methotrexate
4. Patients whose written consent are obtained for participation in this study

Exclusion Criteria

1. Patients who have regularly taken supplements or health foods containing folic acid within 8 weeks before starting this study
2. Patients who are lack of medication compliance due to cognitive impairment
3. Patients who are unable to visit our hospital regularly during the 12-week study period
4. Patients judged to be inappropriate by the principal investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified