Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis

Post Graduate Institute of Medical Education and Research, Chandigarh100 enrolled

Overview

To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2 weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy) versus the adverse effects. Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Rheumatoid Arthritis

Interventions

MethotrexateDRUG

Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria * Between 18 years to 65 year of age * Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1 * Not on methotrexate in the last 2 months * Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day * Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization Exclusion Criteria: * Pregnant/Breastfeeding * Ongoing/Recent treatment with methotrexate (2 months) * Chronic liver disease * Renal failure * Any leucopenia or thrombocytopenia * Breast-feeding * Desirous of pregnancy in the next 6 months * Known Hepatitis B or C positive * Known clinically relevant chronic lung disease: ILD * Tuberculosis or other active infections * Known HIV positive

Locations (1)

New OPD Block, Rheumatology Clinic, Level 3

Chandigarh, Chandigarh, India

Outcomes

Primary Outcomes

Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline

DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity

Time frame: 12 weeks

Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)

Time frame: 3 months

Secondary Outcomes

Proportion of Patients Who Withdrew Because of Any Cause

Time frame: 3 months

Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)

Time frame: 3 months

Proportion Who Withdrew Due to Intolerance

Time frame: 3 months

Data from ClinicalTrials.gov

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