Rheumatoid Arthritis Clinical Trial
— FOLVARIOfficial title:
Randomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis
Verified date | February 2014 |
Source | Postgraduate Institute of Medical Education and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: IEC |
Study type | Interventional |
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. Adverse effects due to methotrexate
a. Minor adverse effects: By symptom chart
a. Major adverse effects: Cytopenia (predefined) and transaminitis.
2. Disease activity using Disease activity score 28 joints (3 variable) and functional
status by health assessment questionnaire
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.
Patients will be administered adverse effects proforma, assessed for having cytopenias and
transaminitis (pre defined) and disease activity will be calculated at every visit, ie., in
the beginning at then at 8,16 and 24 weeks. In addition will look at the functional status
and RBC folate levels at 0 and 24 weeks. Statistical analysis using chi-square test for
proportions and t test for continuous variables.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 18-75 years - Patients fulfilling the 1987 American College of Rheumatology Rheumatoid arthritis criteria Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | New OPD, #3035, Level 3, Rheumatology Clinic, Tuesday and Friday | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | 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 | No |
Secondary | RBC folic acid: | This will be done by chemiluminescence assay, to compare folic acid levels at baseline and at 24 weeks | 24 weeks | No |
Secondary | Function | Look at the function by Indian Health assessment questionnaire | 24 weeks | No |
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