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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT01404429

NKG/992

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Methotrexate 7.5 mg per week

Active Comparator group

Treatment:

Drug: Methotrexate

Methotrexate 15 mg per week

Experimental group

Treatment:

Drug: Methotrexate