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An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01071798
First received: February 18, 2010
Last updated: January 25, 2016
Last verified: January 2016
Results First Received: November 12, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Intervention: Drug: Rituximab

  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
Data were recorded throughout Germany in 264 study centers.

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
Main Analysis Set Participants who received at least one cycle of rituximab

Participant Flow for 2 periods

Period 1:   Participants Who Received One Cycle
    Main Analysis Set  
STARTED     1653  
Baseline and Safety Analysis Set     1653  
COMPLETED     1588  
NOT COMPLETED     65  
Lack of Efficacy                 18  
Lack of tolerability                 14  
Patient requirement                 20  
Death                 5  
Change of therapy                 6  
Severe concomitant disease                 2  

Period 2:   Subpopulation Who Received Two Cycles
    Main Analysis Set  
STARTED     820  
Baseline and Safety Analysis Set     820  
COMPLETED     805  
NOT COMPLETED     15  
Remission                 1  
Lack of Efficacy                 3  
Lack of Tolerability                 4  
Patient Requirement                 7  



  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.
Main analysis population

Reporting Groups
  Description
Main Analysis Set Participants who received at least one cycle of rituximab

Baseline Measures
    Main Analysis Set  
Number of Participants  
[units: participants]
  1653  
Age  
[units: years]
Median (Inter-Quartile Range)
  60.0  
  (52.0 to 71.0)  
Gender  
[units: participants]
 
Female     1199  
Male     454  



  Outcome Measures
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1.  Primary:   DAS28 Score   [ Time Frame: at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle ]

2.  Primary:   HAQ Disability Index (HAQ-DI)   [ Time Frame: at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle ]

3.  Secondary:   Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)   [ Time Frame: during Cycle 1, during Cycle 2, during the trial (within 12 months) ]

4.  Secondary:   Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)   [ Time Frame: 24 weeks after starting Cycle 1 ]

5.  Secondary:   Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)   [ Time Frame: 24 weeks after starting Cycle 2 ]


  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: 1-800-821-8590
e-mail: genentech@druginfo.com


Publications of Results:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01071798     History of Changes
Other Study ID Numbers: ML22639
Study First Received: February 18, 2010
Results First Received: November 12, 2015
Last Updated: January 25, 2016
Health Authority: Germany: Paul-Ehrlich-Institut