An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01669902
First received: August 13, 2012
Last updated: October 21, 2015
Last verified: October 2015
Results First Received: October 21, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis

  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 with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.

Participant Flow:   Overall Study
    Tocilizumab  
STARTED     107  
COMPLETED     78  
NOT COMPLETED     29  
Adverse Event                 11  
Lack of Efficacy                 10  
Unspecified                 8  



  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.
Safety Analysis Set included all data from all participants who received at least one injection with tocilizumab.

Reporting Groups
  Description
Tocilizumab Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.

Baseline Measures
    Tocilizumab  
Number of Participants  
[units: participants]
  107  
Age  
[units: years]
Mean (Standard Deviation)
  56.6  (13.3)  
Gender  
[units: participants]
 
Female     84  
Male     23  



  Outcome Measures
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1.  Primary:   Percentage of Participants on Tocilizumab Treatment at Month 6   [ Time Frame: Month 6 ]

2.  Secondary:   Percentage of Participants With Dose Modifications of Tocilizumab   [ Time Frame: Baseline to Month 6 ]

3.  Secondary:   Swollen Joint Count (SJC)   [ Time Frame: Baseline, Month 3, Month 6 ]

4.  Secondary:   Tender Joint Count (TJC)   [ Time Frame: Baseline, Month 3, Month 6 ]

5.  Secondary:   Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])   [ Time Frame: Baseline, Month 3, Month 6 ]

6.  Secondary:   Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)   [ Time Frame: Month 3 and Month 6 ]

7.  Secondary:   Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])   [ Time Frame: Baseline, Month 3, Month 6 ]

8.  Secondary:   Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)   [ Time Frame: Month 3 and Month 6 ]

9.  Secondary:   Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)   [ Time Frame: Month 3 and Month 6 ]

10.  Secondary:   Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)   [ Time Frame: Month 3 and Month 6 ]

11.  Secondary:   Simplified Disease Activity Index (SDAI)   [ Time Frame: Baseline, Month 3, Month 6 ]

12.  Secondary:   Percentage of Participants Achieving Clinical Remission Based on SDAI   [ Time Frame: Month 3 and Month 6 ]

13.  Secondary:   Clinical Disease Activity Index (CDAI)   [ Time Frame: Baseline, Month 3, Month 6 ]

14.  Secondary:   Percentage of Participants Achieving Clinical Remission Based on CDAI   [ Time Frame: Month 3 and Month 6 ]

15.  Secondary:   Number of Participants With an American College of Rheumatology (ACR) Response   [ Time Frame: Baseline to Month 6 ]

16.  Secondary:   Patient Global Assessment (PtGA) of Disease Activity Score   [ Time Frame: Baseline, Month 3, Month 6 ]

17.  Secondary:   Physician Global Assessment (PGA) of Disease Activity   [ Time Frame: Baseline, Month 3, Month 6 ]

18.  Secondary:   Percentage of Participants in a PGA of Disease Activity Score Category   [ Time Frame: Baseline, Month 3, Month 6 ]

19.  Secondary:   Patient Global Assessment of Pain   [ Time Frame: Baseline, Month 3, Month 6 ]

20.  Secondary:   Percentage of Participants With Morning Stiffness   [ Time Frame: Baseline, Month 3, Month 6 ]

21.  Secondary:   Percentage of Participants With Duration of Morning Stiffness   [ Time Frame: Baseline, Month 3, Month 6 ]

22.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6   [ Time Frame: Baseline, Month 3 and Month 6 ]

23.  Secondary:   Percentage of Participants With Concomitant Corticosteroids Treatment   [ Time Frame: Baseline to Month 6 ]

24.  Secondary:   Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study   [ Time Frame: Baseline to Month 6 ]


  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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01669902     History of Changes
Other Study ID Numbers: ML28247
Study First Received: August 13, 2012
Results First Received: October 21, 2015
Last Updated: October 21, 2015
Health Authority: Sweden: Regional Ethical Review Board