An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00720798
First received: July 22, 2008
Last updated: September 26, 2014
Last verified: September 2014
Results First Received: June 10, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Tocilizumab
Drug: Disease-modifying anti-rheumatic drugs
Drug: Non-steroidal anti-inflammatory drugs
Drug: Oral corticosteroids

  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
Tocilizumab Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.

Participant Flow:   Overall Study
    Tocilizumab  
STARTED     2067  
COMPLETED     1311  
NOT COMPLETED     756  
Adverse Event                 304  
Death                 39  
Insufficient Therapeutic Response                 129  
Protocol Violation                 4  
Refused Treatment                 151  
Failure to Return                 46  
Reason not Specified                 83  



  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-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

Reporting Groups
  Description
Tocilizumab Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.

Baseline Measures
    Tocilizumab  
Number of Participants  
[units: participants]
  2067  
Age  
[units: years]
Mean ± Standard Deviation
  52.2  ± 12.60  
Gender  
[units: participants]
 
Female     1689  
Male     378  



  Outcome Measures
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1.  Primary:   Percentage of Participants With ≥ 1 Adverse Event   [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ]

2.  Secondary:   Percentage of Participants Who Withdrew From Treatment   [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ]

3.  Secondary:   Percentage of Participants With Concomitant Oral Corticosteroid Therapy   [ Time Frame: Baseline to the end of the study (up to 7 years, 7 months) ]

4.  Secondary:   Percentage of Participants Who Changed From Monotherapy to Combination Therapy   [ Time Frame: Baseline to Week 296 ]

5.  Secondary:   Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]

6.  Secondary:   Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264   [ Time Frame: Baseline to Week 264 ]

7.  Secondary:   Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264   [ Time Frame: Baseline to Week 264 ]

8.  Secondary:   Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]

9.  Secondary:   Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]

10.  Secondary:   Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]

11.  Secondary:   Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]

12.  Secondary:   Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264   [ Time Frame: Baseline to Week 264 ]

13.  Secondary:   Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]

14.  Secondary:   Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264   [ Time Frame: Baseline to Week 264 ]

15.  Secondary:   Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]

16.  Secondary:   Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264   [ Time Frame: Baseline to Week 264 ]


  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-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00720798     History of Changes
Other Study ID Numbers: WA18696
Study First Received: July 22, 2008
Results First Received: June 10, 2014
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration