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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varun Dhir, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01404429
First received: July 26, 2011
Last updated: September 5, 2014
Last verified: September 2014
Results First Received: August 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Drug: Methotrexate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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)
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)

Participant Flow:   Overall Study
    Methotrexate 7.5 mg Per Week     Methotrexate 15 mg Per Week  
STARTED     47     53  
COMPLETED     38     46  
NOT COMPLETED     9     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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)
Methotrexate 15 mg Per Week Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
Total Total of all reporting groups

Baseline Measures
    Methotrexate 7.5 mg Per Week     Methotrexate 15 mg Per Week     Total  
Number of Participants  
[units: participants]
  47     53     100  
Age  
[units: years]
Mean ± Standard Deviation
  44.5  ± 10.3     42.8  ± 11.2     43.6  ± 10.8  
Gender  
[units: participants]
     
Female     37     41     78  
Male     10     12     22  



  Outcome Measures
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1.  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   [ Time Frame: 12 weeks ]

2.  Primary:   Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)   [ Time Frame: 3 months ]

3.  Secondary:   Proportion of Patients Who Withdrew Because of Any Cause   [ Time Frame: 3 months ]

4.  Secondary:   Proportion Who Withdrew Due to Intolerance   [ Time Frame: 3 months ]

5.  Secondary:   Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Varun Dhir, Assistant Professor, Internal Medicine
Organization: PGIMER, India
phone: +91-8872229998
e-mail: varundhir@gmail.com


No publications provided by Postgraduate Institute of Medical Education and Research

Publications automatically indexed to this study:

Responsible Party: Varun Dhir, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01404429     History of Changes
Other Study ID Numbers: NKG/992
Study First Received: July 26, 2011
Results First Received: August 9, 2014
Last Updated: September 5, 2014
Health Authority: India: Institutional Review Board