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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate 7.5 mg per week | Active Comparator |
| |
| Methotrexate 15 mg per week | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Withdrew Because of Any Cause | 3 months | |
| Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New OPD Block, Rheumatology Clinic, Level 3 | Chandigarh | Chandigarh | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24976447 | Derived | 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. |
| Label | URL |
|---|---|
| published manuscript | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methotrexate 7.5 mg Per Week | Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly) |
| FG001 | Methotrexate 15 mg Per Week | Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methotrexate 7.5 mg Per Week | Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly) |
| BG001 | Methotrexate 15 mg Per Week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methotrexate 7.5 mg Per Week | Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Varun Dhir, Assistant Professor, Internal Medicine | PGIMER, India | +91-8872229998 | varundhir@gmail.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Proportion Who Withdrew Due to Intolerance | 3 months |
Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2) | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Proportion of Patients Who Withdrew Because of Any Cause | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU) | Not Posted | 3 months |
| Secondary | Proportion Who Withdrew Due to Intolerance | Posted | Number | participants | 3 months |
|
|
|
| 0 |
| 47 |
| 9 |
| 47 |
| EG001 | Methotrexate 15 mg Per Week | Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly) | 0 | 53 | 22 | 53 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |