Study of two different starting doses of methotrexate when starting treatment in rheumatoid arthritis

Phase 3

Completed

• Conditions: Health Condition 1: null- Rheumatoid Arthritis

• Registration Number: CTRI/2011/07/001924
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria

2.Between 18 years to 65 year of age

3.Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1

4.Not on methotrexate in the last 2 months

5.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

6.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

1.Pregnant/Breastfeeding

2.Ongoing/Recent treatment with methotrexate (2 months)

3.Standard exclusion for MTX treatment

a.Chronic liver disease

b.Renal failure

c.Any leucopenia or thrombocytopenia

d.Breast-feeding

e.Desirous of pregnancy in the next 6 months

f.Known Hepatitis B or C positive

g.Known clinically relevant chronic lung disease: ILD

h.Tuberculosis or other active infections

i.Known HIV positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified