An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01394276
First received: July 13, 2011
Last updated: April 30, 2016
Last verified: April 2016
Results First Received: April 30, 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
A total of 322 participants were enrolled across 59 study centers in Italy from 31 May 2011 to 24 April 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tocilizumab Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra [Tocilizumab (TCZ)] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).

Participant Flow:   Overall Study
    Tocilizumab  
STARTED     322  
COMPLETED     260  
NOT COMPLETED     62  
Related Adverse event (AEs)                 15  
Not related AEs                 9  
Remission of disease                 2  
Insufficient therapeutic effect                 17  
Insufficient compliance                 9  
Lost to Follow-up                 5  
Participant moved to another site                 1  
Pregnancy                 1  
unavailability of drug at the Hospital                 2  
Symptoms of concurrent diseases                 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.
The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.

Reporting Groups
  Description
Tocilizumab Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.

Baseline Measures
    Tocilizumab  
Number of Participants  
[units: participants]
  322  
Age  
[units: years]
Mean (Standard Deviation)
  55.8  (11.6)  
Gender  
[units: participants]
 
Female     260  
Male     62  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment   [ Time Frame: Up to 12 months ]

2.  Primary:   Percentage of Participants Achieving Disease Remission After 6 Months of Treatment   [ Time Frame: Up to 12 months ]

3.  Secondary:   Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab   [ Time Frame: Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12 ]

4.  Secondary:   Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

5.  Secondary:   Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

6.  Secondary:   Number of Participants With Concomitant Medications   [ Time Frame: Up to 12 months ]

7.  Secondary:   Percentage of Participants Discontinuing Treatment With Tocilizumab   [ Time Frame: Up to 12 months ]

8.  Secondary:   Number of Participants With Any Adverse Events and Serious Adverse Events   [ Time Frame: Up to 12 months ]

9.  Secondary:   Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion   [ Time Frame: Up to 12 months ]

10.  Secondary:   Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

11.  Secondary:   Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

12.  Secondary:   Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

13.  Secondary:   Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

14.  Secondary:   Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

15.  Secondary:   Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]

16.  Secondary:   Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents   [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12 ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 61 6878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01394276     History of Changes
Other Study ID Numbers: ML25728
Study First Received: July 13, 2011
Results First Received: April 30, 2016
Last Updated: April 30, 2016
Health Authority: Italy: Ministry of Health