Phase 4
Completed N=100
Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01404429 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: 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 — -0.47; -0.55 units on a scale — p=0.6
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-0.47; -0.55 | 0.6 |
| PRIMARY Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2) |
0; 1 | — |
| SECONDARY Proportion of Patients Who Withdrew Because of Any Cause |
9; 7 | — |
| SECONDARY Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU) |
— | — |
| SECONDARY Proportion Who Withdrew Due to Intolerance |
2; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01404429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.