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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Active

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New OPD Block, Rheumatology Clinic, Level 3

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Methotrexate 7.5 mg per week

Methotrexate 15 mg per week

Arm Description

Outcomes

Primary Outcome Measures

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
Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2011
Last Updated
September 5, 2014
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01404429
Brief Title
Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Acronym
DMIRA
Official Title
Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Active

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate 7.5 mg per week
Arm Type
Active Comparator
Arm Title
Methotrexate 15 mg per week
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MEXATE
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
12 weeks
Title
Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of Patients Who Withdrew Because of Any Cause
Time Frame
3 months
Title
Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)
Time Frame
3 months
Title
Proportion Who Withdrew Due to Intolerance
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
New OPD Block, Rheumatology Clinic, Level 3
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
24976447
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.
Results Reference
derived
Links:
URL
http://dx.doi.org/10.1016/j.clinthera.2014.05.063
Description
published manuscript

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

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