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A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01353859
First received: May 13, 2011
Last updated: May 8, 2014
Last verified: May 2014
Results First Received: April 22, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: tocilizumab [RoActemra/Actemra]
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
No text entered.

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
Tocilizumab + Methotrexate (MTX) Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.

Participant Flow:   Overall Study
    Tocilizumab + Methotrexate (MTX)  
STARTED     39  
COMPLETED     35  
NOT COMPLETED     4  
Adverse Event                 3  
Lack of Efficacy                 1  



  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.
Intent to treat (ITT) population: all participants included in the study who received at least one dose of study medication. Participants prematurely withdrawn from the study will be considered as nonresponders at the end of the study in all analyses of treatment response variables.

Reporting Groups
  Description
Tocilizumab + MTX Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.

Baseline Measures
    Tocilizumab + MTX  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Median ( Full Range )
  53  
  ( 19 to 75 )  
Gender  
[units: participants]
 
Female     36  
Male     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving Low Disease Activity Score   [ Time Frame: Week 24 ]

2.  Secondary:   Time to Achieve Low Disease Activity (DAS28 ≤3.2)   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 ]

3.  Secondary:   Percentage of Participants With a Clinically Significant Improvement in DAS28 Score   [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]

4.  Secondary:   Time to Clinically Significant Improvement in DAS28   [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]

5.  Secondary:   Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]

6.  Secondary:   Time to Achieve DAS28 Remission (DAS28 <2.6)   [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]

7.  Secondary:   Percentage of Participants With DAS28 <3.2 by Visit   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]

8.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response   [ Time Frame: Week 24 ]

9.  Secondary:   Erythrocyte Sedimentation Rate   [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]

10.  Secondary:   C-Reactive Protein Levels   [ Time Frame: Baseline, Weeks 4, 8, 12,16, 20, and 24 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01353859     History of Changes
Other Study ID Numbers: ML25536
Study First Received: May 13, 2011
Results First Received: April 22, 2014
Last Updated: May 8, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control