Clinical trial NCT01404429: Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Official title: Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Active
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2011-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
measure: Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of Patients Who Withdrew Because of Any Cause
timeFrame: 3 months
measure: Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)
timeFrame: 3 months
measure: Proportion Who Withdrew Due to Intolerance
timeFrame: 3 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: New OPD Block, Rheumatology Clinic, Level 3
Study officials:
References:
citation: Dhir V, Singla M, Gupta N, Goyal P, Sagar V, Sharma A, Khanna S, Singh S. Randomized controlled trial comparing 2 different starting doses of methotrexate in rheumatoid arthritis. Clin Ther. 2014 Jul 1;36(7):1005-15. doi: 10.1016/j.clinthera.2014.05.063. Epub 2014 Jun 26.