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

Rheumatoid Arthritis Clinical Trial

— DMIRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404429
• Other study ID #: NKG/992
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2011
• Last updated: September 5, 2014
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2014
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
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

Locations

Country	Name	City	State
India	New OPD Block, Rheumatology Clinic, Level 3	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)		3 months	No
Secondary	Proportion of Patients Who Withdrew Because of Any Cause		3 months	Yes
Secondary	Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)		3 months	Yes
Secondary	Proportion Who Withdrew Due to Intolerance		3 months	Yes

External Links

•   published manuscript