An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592292
First received: April 11, 2012
Last updated: July 6, 2016
Last verified: March 2016
Results First Received: May 3, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Interventions: Drug: Rituximab
Drug: Adalimumab
Drug: Etanercept
Drug: Infliximab

  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
The arm Other anti-TNF agent consisting of participants treated with adalimumab, etanercept and infliximab was divided into individual treatment groups only for the purpose of Participant flow reporting. All other analyses were performed in Rituximab versus Other anti-TNF agent.

Reporting Groups
  Description
Rituximab Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
Other Anti-TNF Agent: Adalimumab Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician’s discretion for RA treatment were observed for 12 months.
Other Anti-TNF Agent: Etanercept Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician’s discretion for RA treatment were observed for 12 months.
Other Anti-TNF Agent: Infliximab Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician’s discretion for RA treatment were observed for 12 months.

Participant Flow:   Overall Study
    Rituximab     Other Anti-TNF Agent: Adalimumab     Other Anti-TNF Agent: Etanercept     Other Anti-TNF Agent: Infliximab  
STARTED     46     20     13     11  
Intention to Treat (ITT) Set     34 [1]   13     10     8  
Standard Population Set (SPS)     31 [2]   10     7     7  
COMPLETED     40 [3]   15     10     10  
NOT COMPLETED     6     5     3     1  
Follow-up loss                 3                 3                 1                 0  
Withdrew consent                 2                 1                 0                 0  
Not specified                 1                 1                 2                 1  
[1] Excluding primary effect evaluation omission.
[2] Excluding participants with change of administration drug or suspension of drug administration.
[3] Participants who completed 12 months visit.



  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 intent to treat (ITT) set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.

Reporting Groups
  Description
Rituximab Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
Other Anti-TNF Agent Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
Total Total of all reporting groups

Baseline Measures
    Rituximab     Other Anti-TNF Agent     Total  
Number of Participants  
[units: participants]
  34     31     65  
Age, Customized  
[units: participants]
     
20-29 years     0     2     2  
30-39 years     4     4     8  
40-49 years     7     7     14  
50-59 years     6     7     13  
60-69 years     15     6     21  
70-79 years     2     5     7  
Gender  
[units: participants]
     
Female     25     26     51  
Male     9     5     14  



  Outcome Measures
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1.  Primary:   Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population   [ Time Frame: Baseline and Month 6 ]

2.  Primary:   Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)   [ Time Frame: Baseline and Month 6 ]

3.  Secondary:   Efficacy: Mean Change From Baseline in DAS28 at Month 12   [ Time Frame: Baseline and Month 12 ]

4.  Secondary:   Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population   [ Time Frame: Baseline, Month 6 and 12 ]

5.  Secondary:   Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)   [ Time Frame: Baseline, Month 6 and 12 ]

6.  Secondary:   Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population   [ Time Frame: Baseline, Month 6 and 12 ]

7.  Secondary:   Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)   [ Time Frame: Baseline, Month 6 and 12 ]

8.  Secondary:   Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population   [ Time Frame: Baseline, Month 6 and 12 ]

9.  Secondary:   Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)   [ Time Frame: Baseline, Month 6 and 12 ]

10.  Secondary:   Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population   [ Time Frame: Baseline, Month 6 and 12 ]

11.  Secondary:   Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)   [ Time Frame: Baseline, Month 6 and 12 ]

12.  Secondary:   Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population   [ Time Frame: Month 6 ]

13.  Secondary:   Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)   [ Time Frame: Month 6 ]

14.  Secondary:   Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events   [ Time Frame: Baseline up to 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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01592292     History of Changes
Other Study ID Numbers: ML27923
Study First Received: April 11, 2012
Results First Received: May 3, 2016
Last Updated: July 6, 2016
Health Authority: Korea: Food and Drug Administration