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

Study Overview
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Brief Summary
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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

Official Title
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Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methotrexate 7.5 mg per week<br> | Drug: Methotrexate<br>* 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<br>* Other names: MEXATE;|
| Experimental: Methotrexate 15 mg per week<br> | Drug: Methotrexate<br>* 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<br>* Other names: MEXATE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who Withdrew Because of Any Cause |  | 3 months | 
| Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU) |  | 3 months | 
| Proportion Who Withdrew Due to Intolerance |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Active