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A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

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ClinicalTrials.gov Identifier: NCT01617005
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : December 1, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Intervention: Drug: Tocilizumab

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Tocilizumab in Moderate to Severe Active RA Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.

Participant Flow:   Overall Study
    Tocilizumab in Moderate to Severe Active RA
STARTED   50 
COMPLETED   48 
NOT COMPLETED   2 
Pregnancy                1 
Lack of motivation for treatment                1 



  Baseline Characteristics

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.
All participants who were enrolled in the study.

Reporting Groups
  Description
Tocilizumab in Moderate to Severe Active RA Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.

Baseline Measures
   Tocilizumab in Moderate to Severe Active RA 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.9  (11.1) 
Gender 
[Units: Participants]
 
Female   41 
Male   9 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)   [ Time Frame: Baseline up to Week 24 ]

2.  Secondary:   Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Number of Participants Who Discontinued Treatment Due to Lack of Efficacy   [ Time Frame: Baseline up to Week 24 ]

4.  Secondary:   Time to Discontinuation Due to Lack of Efficacy   [ Time Frame: Baseline up to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT01617005     History of Changes
Other Study ID Numbers: ML25699
First Submitted: June 8, 2012
First Posted: June 12, 2012
Results First Submitted: October 7, 2016
Results First Posted: December 1, 2016
Last Update Posted: December 1, 2016