Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis

NCT01583959 | Completed Phase 4

• 1 other identifier: P-124
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Methotrexate is the sheet anchor for the treatment of rheumatoid arthritis. Folic acid supplementation is usually given at a dose of 5-30 mg per week to ameliorate adverse effects. Patients at our center are usually on the higher dose. However, it is unclear if higher doses are required, recent international recommendations suggest 5-10 mg per week only. Objectives: To randomize rheumatoid patients being being started on Methotrexate into 2 groups- one on 5mg for 6 days a week (30mg per week) of folic acid and the other 5 mg twice a week (10 mg per week) for 24weeks. To look at difference in

1. 1.Adverse effects due to methotrexate
2. 2.Disease activity using Disease activity score 28 joints (3 variable) and functional status by health assessment questionnaire
3. 3.RBC folic acid levels Methodology: Randomised controlled trial, double blinded, placebo controlled. Sample size 50 in each group. One group of patients will receive folic acid 5 mg twice a week with placebo for 4 days and the other group will receive folic acid 5 mg 6 days a week for 24 weeks.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; folic acid; methotrexate

Outcome Measures

Primary Outcomes (2)

• Adverse effects

  i. Minor: Two Symptom charts: Those AEs related temporally to methotrexate and those not temporally related. ii. Major: Hemoglobin (Hb), Platelet, Total leucocyte count or white blood count (TLC), Differential leukocyte count (DLC), Serum glutamic oxaloacetate transaminase (SGOT)/ serum glutamic pyruvate transaminase (SGPT) will be done at 3 months. Patients having Hb≤6, TLC ≤ 3500, Platelet ≤99000, SGOT or SGPT ≥80 IU/L

  24 weeks

• disease activity

  Using disease activity score 28 joints 3 variables(DAS 28-3v) : uses evaluation of tender joint count (TJC28), Swollen joint count (SJC28) and the erythrocyte sedimentation rate (ESR) using Westergren method.

  24 weeks

Secondary Outcomes (2)

• RBC folic acid:

  24 weeks

• Function

  24 weeks

Study Arms (2)

Folic acid 30 mg per week

ACTIVE COMPARATOR

Patients will be administered 5 mg folic acid for 6 days a week, no tablet on the day they take methotrexate (5 mg x 6 days = 30 mg per week)

Drug: Folic Acid

Folic acid 10 mg

ACTIVE COMPARATOR

Patients will be given folic acid 5 mg for two days per week and placebo tablets for four days a week, no tablet on the day they take methotrexate (Folic acid 5mg x 2 days = 10mg per week)

Drug: Folic Acid; Drug: Placebo

Interventions

Folic Acid DRUG

Folic acid tablets 5 mg

Folic acid 10 mg; Folic acid 30 mg per week

Placebo DRUG

Matched placebo to folic acid 5 mg tables, to be given for 4 days a week

Folic acid 10 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Patients fulfilling the 1987 American College of Rheumatology Rheumatoid arthritis criteria

You may not qualify if:

• Hb less than 8 g per dl or TLC less than 3500 or Platelet less than 1 lac or SGOT or SGPT more than 60 U/L
• Serious concomitant medical illnesses such as cancer, liver or renal disease

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

New OPD, #3035, Level 3, Rheumatology Clinic, Tuesday and Friday

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (1)

• Dhir V, Sandhu A, Kaur J, Pinto B, Kumar P, Kaur P, Gupta N, Sood A, Sharma A, Sharma S. Comparison of two different folic acid doses with methotrexate--a randomized controlled trial (FOLVARI Study). Arthritis Res Ther. 2015 Jun 11;17(1):156. doi: 10.1186/s13075-015-0668-4.

  PMID: 26063325 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Varun Dhir, MD, DM

  PGIMER, Chandigarh, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

IN (1)