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A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01671059
First received: August 20, 2012
Last updated: October 7, 2016
Last verified: October 2016
Results First Received: October 7, 2016  
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
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 Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.

Participant Flow:   Overall Study
    Tocilizumab
STARTED   80 
COMPLETED   75 
NOT COMPLETED   5 
Adverse Event                4 
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.
Enrolled participants.

Reporting Groups
  Description
Tocilizumab Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.

Baseline Measures
   Tocilizumab 
Overall Participants Analyzed 
[Units: Participants]
 80 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.6  (11.98) 
Gender 
[Units: Participants]
 
Female   67 
Male   13 


  Outcome Measures
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1.  Primary:   Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation   [ Time Frame: 6 months ]

2.  Secondary:   Percentage of Participants With Dose Modifications   [ Time Frame: 6 months ]

3.  Secondary:   Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)   [ Time Frame: 6 months ]

4.  Secondary:   Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents   [ Time Frame: Baseline ]

5.  Secondary:   Reasons for Dose Modifications   [ Time Frame: 6 months ]

6.  Secondary:   Percentage of Participants With Dose Interruptions   [ Time Frame: 6 months ]

7.  Secondary:   Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy   [ Time Frame: 6 months ]

8.  Secondary:   Percentage of Participants on Tocilizumab Monotherapy at Study Entry   [ Time Frame: 6 months ]

9.  Secondary:   Disease Activity Score Based on 28-Joint Count (DAS28)   [ Time Frame: 6 months ]

10.  Secondary:   Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category   [ Time Frame: 6 months ]

11.  Secondary:   Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category   [ Time Frame: 6 months ]

12.  Secondary:   Simplified Disease Activity Index (SDAI)   [ Time Frame: 6 months ]

13.  Secondary:   Clinical Disease Activity Index (CDAI) Score   [ Time Frame: 6 months ]

14.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) Response   [ Time Frame: 6 months ]

15.  Secondary:   Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)   [ Time Frame: 6 months ]

16.  Secondary:   Patient Global Assessment of Disease Activity Score   [ Time Frame: 6 months ]

17.  Secondary:   Health Assessment Questionnaire Disability Index (HAQ-DI)   [ Time Frame: 6 months ]

18.  Secondary:   Visual Analogue Scale (VAS) for Fatigue   [ Time Frame: 6 months ]

19.  Secondary:   Visual Analogue Scale (VAS) for Morning Stiffness   [ Time Frame: 6 months ]

20.  Secondary:   Visual Analogue Scale (VAS) for Pain   [ Time Frame: 6 months ]


  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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01671059     History of Changes
Other Study ID Numbers: ML28314
Study First Received: August 20, 2012
Results First Received: October 7, 2016
Last Updated: October 7, 2016
Health Authority: Serbia: Agency for medicines and medical devices