A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01272908
First received: January 7, 2011
Last updated: July 8, 2014
Last verified: July 2014
Results First Received: May 12, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
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
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
Rituximab + Methotrexate (MTX) Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg per week (mg/week) and a stable dose of folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (Disease Activity Score based on 28-Joint Count [DAS28] score of greater than or equal to [≥]2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg], given 14 days apart), at any time between Week 24 and 48.

Participant Flow for 2 periods

Period 1:   Initial Treatment Period
    Rituximab + Methotrexate (MTX)  
STARTED     120  
COMPLETED     112  
NOT COMPLETED     8  
Adverse Event                 1  
Lack of Efficacy                 5  
Protocol Violation                 1  
Withdrawal by Subject                 1  

Period 2:   Re-Treatment Period
    Rituximab + Methotrexate (MTX)  
STARTED     77 [1]
COMPLETED     71  
NOT COMPLETED     6  
Adverse Event                 2  
Lack of Efficacy                 3  
Withdrawal by Subject                 1  
[1] Only participants with active disease as characterized by DAS-28 score ≥2.6 were included.



  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.
Intent-to-Treat (ITT) Population: all participants who recieved any amount of infused medication whether or not they completed any further assessment.

Reporting Groups
  Description
Rituximab + MTX Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.

Baseline Measures
    Rituximab + MTX  
Number of Participants  
[units: participants]
  120  
Age  
[units: years]
Median ± Standard Deviation
  55.6  ± 10.20  
Gender  
[units: participants]
 
Female     87  
Male     33  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary   [ Time Frame: Days 1, 2, 15, and 16 and Week 48 of Initial treatment period ]

2.  Secondary:   Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary   [ Time Frame: Days 1, 2, 15, and 16 and Week 48 of Re-treatment period ]

3.  Secondary:   Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

4.  Secondary:   Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

5.  Secondary:   Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

6.  Secondary:   Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

7.  Secondary:   Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

8.  Secondary:   Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

9.  Secondary:   Change From Baseline in DAS28 During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

10.  Secondary:   Change From Baseline in DAS28 During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

11.  Secondary:   Change From Baseline in SJC During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

12.  Secondary:   Change From Baseline in SJC During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

13.  Secondary:   Change From Baseline in TJC During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

14.  Secondary:   Change From Baseline in TJC During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

15.  Secondary:   Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

16.  Secondary:   Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

17.  Secondary:   Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

18.  Secondary:   Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance ]

19.  Secondary:   Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

20.  Secondary:   Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

21.  Secondary:   Change From Baseline HAQ-DI Score During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

22.  Secondary:   Change From Baseline HAQ-DI Score During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

23.  Secondary:   Change From Baseline in ESR During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

24.  Secondary:   Change From Baseline in ESR During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

25.  Secondary:   Change From Baseline in CRP During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

26.  Secondary:   Change From Baseline CRP During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

27.  Secondary:   Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

28.  Secondary:   Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]

29.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period   [ Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period ]

30.  Secondary:   Change From Baseline in FACIT-F Total Score During the Re-Treatment Period   [ Time Frame: Weeks 12 and 24 of Re-treatment period ]


  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
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.


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


No publications provided


Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01272908     History of Changes
Other Study ID Numbers: ML20381
Study First Received: January 7, 2011
Results First Received: May 12, 2014
Last Updated: July 8, 2014
Health Authority: Canada: Health Canada