A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01089023
First received: March 8, 2010
Last updated: June 23, 2014
Last verified: June 2014
Results First Received: June 23, 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
Intervention: Drug: tocilizumab [RoActemra/Actemra]

  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
No text entered.

Reporting Groups
  Description
Tocilizumab 8 Milligrams Per Kilogram (mg/kg) Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.

Participant Flow:   Overall Study
    Tocilizumab 8 Milligrams Per Kilogram (mg/kg)  
STARTED     95  
COMPLETED     88  
NOT COMPLETED     7  
Lost to Follow-up                 3  
Adverse Event                 1  
Withdrawal by Subject                 1  
Protocol Violation                 1  
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.
All the participants who were administered treatment at each visit were considered during the analysis.

Reporting Groups
  Description
Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.

Baseline Measures
    Tocilizumab 8 mg/kg  
Number of Participants  
[units: participants]
  95  
Age  
[units: years]
Mean ± Standard Deviation
  44.89  ± 13.677  
Gender  
[units: participants]
 
Female     78  
Male     17  



  Outcome Measures
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1.  Primary:   Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24 ]

2.  Secondary:   Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]

3.  Secondary:   Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

4.  Secondary:   Time to DAS28 Response by DAS28 Category   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

5.  Secondary:   Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units   [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]

6.  Secondary:   Percentage of Participants With Improvement in Physical Function by HAQ-DI Category   [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]

7.  Secondary:   HAQ-DI Score by Visit   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]

8.  Secondary:   C-Reactive Protein (CRP) Values by Study Visit   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]

9.  Secondary:   Erythrocyte Sedimentation Rate   [ Time Frame: Baseline and 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
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.


  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: NCT01089023     History of Changes
Other Study ID Numbers: ML22440
Study First Received: March 8, 2010
Results First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: Qatar: Ministry of Health