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A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01562327
First received: March 21, 2012
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: June 29, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Intervention: Drug: Tocilizumab

  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 moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.

Participant Flow:   Overall Study
    Tocilizumab
STARTED   50 
COMPLETED   42 
NOT COMPLETED   8 
Adverse Event                2 
Lack of Efficacy                1 
Participant drop-out                1 
Infusion not received at 6 month window                4 



  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.
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Reporting Groups
  Description
Tocilizumab Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.

Baseline Measures
   Tocilizumab 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.9  (12.2) 
Gender 
[Units: Participants]
 
Female   41 
Male   9 


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

2.  Secondary:   Percentage of Participants With Systemic Manifestations of RA at Baseline   [ Time Frame: Baseline ]

3.  Secondary:   Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab   [ Time Frame: Baseline ]

4.  Secondary:   Percentage of Participants Who Previously Received DMARDs   [ Time Frame: Baseline ]

5.  Secondary:   Reason for DMARDs Withdrawal at Baseline   [ Time Frame: Baseline ]

6.  Secondary:   Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab   [ Time Frame: Baseline ]

7.  Secondary:   Percentage of Participants Who Previously Received Biologic Agents   [ Time Frame: Baseline ]

8.  Secondary:   Reason for Biologic Agent Withdrawal at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Reasons for Dose Modifications   [ Time Frame: approximately 3 years ]

10.  Secondary:   Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy   [ Time Frame: Approximately 3 years ]

11.  Secondary:   Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy   [ Time Frame: Baseline, Month 6 ]

12.  Secondary:   Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

13.  Secondary:   Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

14.  Secondary:   Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6   [ Time Frame: Month 3, Month 6 ]

15.  Secondary:   Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6   [ Time Frame: Month 3, Month 6 ]

16.  Secondary:   Simplified Disease Activity (SDAI) Response Classification   [ Time Frame: Month 3, Month 6 ]

17.  Secondary:   European League Against Rheumatism (EULAR) Response   [ Time Frame: Month 3, Month 6 ]

18.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6   [ Time Frame: Month 3, Month 6 ]

19.  Secondary:   Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

20.  Secondary:   Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

21.  Secondary:   Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)   [ Time Frame: Baseline, Month 3, Month 6 ]

22.  Secondary:   Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

23.  Secondary:   Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

24.  Secondary:   Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

25.  Secondary:   Percentage of Participants With an Adverse Event (AE)   [ Time Frame: approximately 3 years ]


  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: NCT01562327     History of Changes
Other Study ID Numbers: ML28142
Study First Received: March 21, 2012
Results First Received: June 29, 2016
Last Updated: October 18, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica