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

Information source: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Methotrexate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Postgraduate Institute of Medical Education and Research

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

Proportion of Patients Who Withdrew Because of Any Cause

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

Proportion Who Withdrew Due to Intolerance

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 and Contacts

New OPD Block, Rheumatology Clinic, Level 3, Chandigarh 160012, India
Additional Information

published manuscript

Starting date: May 2011
Last updated: September 5, 2014

Page last updated: August 23, 2015

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