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

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate

• Registration Number: NCT01404429
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Results First Submitted: 2014-08-09
• Results First Submitted QC: 2014-08-25
• Status Verified: 2014-09
• Results First Posted: 2014-09-05
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate 7.5 mg per week	Methotrexate	-
Methotrexate 15 mg per week	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)	3 months
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	12 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New OPD Block, Rheumatology Clinic, Level 3; 🇮🇳 Chandigarh, India