Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01683604
First received: September 5, 2012
Last updated: June 10, 2016
Last verified: June 2016
Results First Received: April 20, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Intervention: Other: Observational study

  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
Rheumatoid Arthritis (RA) Participants (All Groups) Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.

Participant Flow:   Overall Study
    Rheumatoid Arthritis (RA) Participants (All Groups)  
STARTED     37  
COMPLETED     32  
NOT COMPLETED     5  
Adverse Event                 2  
Lack of Efficacy                 1  
Unspecified                 2  



  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.
Full Analysis Set (FAS): All enrolled participants who received at least 1 dose of tocilizumab.

Reporting Groups
  Description
RA Participants (All Groups) Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.

Baseline Measures
    RA Participants (All Groups)  
Number of Participants  
[units: participants]
  37  
Age  
[units: years]
Mean (Standard Deviation)
  59.3  (10.62)  
Gender  
[units: participants]
 
Female     21  
Male     16  



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

2.  Primary:   Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline   [ Time Frame: Baseline ]

3.  Primary:   Patient Global Assessment of Disease Activity Using VAS at Baseline   [ Time Frame: Baseline ]

4.  Primary:   Physician Global Assessment of Disease Activity Using VAS at Baseline   [ Time Frame: Baseline ]

5.  Primary:   Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline   [ Time Frame: Baseline ]

6.  Primary:   Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline   [ Time Frame: Baseline ]

7.  Primary:   Erythrocyte Sedimentation Rate (ESR) at Baseline   [ Time Frame: Baseline ]

8.  Primary:   C-Reactive Protein (CRP) at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs   [ Time Frame: Baseline ]

10.  Secondary:   Median Dose at Month 6   [ Time Frame: Month 6 ]

11.  Secondary:   Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change   [ Time Frame: Baseline up to Month 6 ]

12.  Secondary:   Mean Dosing Interval at Month 6   [ Time Frame: Month 6 ]

13.  Secondary:   Percentage of Participants With Reasons Who Discontinued Tocilizumab   [ Time Frame: Baseline up to Month 6 ]

14.  Secondary:   Time to Restoration of Initial Dosing Regimen   [ Time Frame: Baseline up to Month 6 ]

15.  Secondary:   Percentage of Participants by Reason for Choice of Monotherapy at Baseline   [ Time Frame: Baseline up to Month 6 ]

16.  Secondary:   Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6   [ Time Frame: Baseline, Month 6 ]

17.  Secondary:   Duration of Tocilizumab Treatment   [ Time Frame: Baseline up to Month 6 ]

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

19.  Secondary:   Percentage of Participants With and Without Morning Stiffness   [ Time Frame: Baseline, Month 3, Month 6 ]

20.  Secondary:   Percentage of Participants Adhering to Local Label for Adverse Events   [ Time Frame: Baseline up to Month 6 ]

21.  Secondary:   Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit   [ Time Frame: Baseline, Month 3, Month 6 ]

22.  Secondary:   Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6   [ Time Frame: Month 3 and Month 6 ]

23.  Secondary:   Clinical Disease Activity Index (CDAI) Score by Visit   [ Time Frame: Baseline, Month 3, Month 6 ]

24.  Secondary:   Change From Baseline in TJC and SJC at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, Month 6 ]

25.  Secondary:   Simplified Disease Activity Index (SDAI) Score by Visit   [ Time Frame: Baseline, Month 3, Month 6 ]

26.  Secondary:   Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment   [ Time Frame: Month 3 and Month 6 ]

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

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

29.  Secondary:   Change From Baseline in HAQ-DI Score at Months 3 and 6   [ Time Frame: Baseline, Month 3, Month 6 ]

30.  Secondary:   Change From Baseline in VAS-Fatigue at Months 3 and 6   [ Time Frame: Baseline, Month 3, Month 6 ]

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

32.  Secondary:   Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6   [ Time Frame: Baseline, Month 3, 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: HoffmannLaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01683604     History of Changes
Other Study ID Numbers: ML28144
Study First Received: September 5, 2012
Results First Received: April 20, 2016
Last Updated: June 10, 2016
Health Authority: Australia: National Health and Medical Research Council