A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00462345
First received: April 18, 2007
Last updated: October 30, 2014
Last verified: October 2014
Results First Received: May 8, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: rituximab
Drug: Methotrexate
Drug: Corticosteroid or NSAID
Dietary Supplement: Folate

  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
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Reporting Groups
  Description
Rituximab, Methotrexate Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.

Participant Flow:   Overall Study
    Rituximab, Methotrexate  
STARTED     40  
Completed First Course     38  
COMPLETED     37  
NOT COMPLETED     3  
Withdrawal by Subject                 2  
Did not complete second course                 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.
Intent to treat (ITT) population included all enrolled participants who received the investigational treatment.

Reporting Groups
  Description
Rituximab, Methotrexate Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.

Baseline Measures
    Rituximab, Methotrexate  
Number of Participants  
[units: participants]
  40  
Age  
[units: years]
Mean ± Standard Deviation
  49.9  ± 11.4  
Gender  
[units: participants]
 
Female     34  
Male     6  



  Outcome Measures
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1.  Primary:   Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Disease Activity Score Based on 28-Joint Count (DAS-28)   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:   Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:   Swollen Join Count (SJC)   [ Time Frame: Baseline, Weeks 24 and 48 ]

8.  Secondary:   Tender Joint Count (TJC)   [ Time Frame: Baseline, Weeks 24 and 48 ]

9.  Secondary:   Patient Global Assessment of Disease Activity (VAS)   [ Time Frame: Baseline, Weeks 24 and 48 ]

10.  Secondary:   Physician Global Assessment of Disease Activity (VAS)   [ Time Frame: Baseline, Weeks 24 and 48 ]

11.  Secondary:   Patient Assessment of Pain (VAS)   [ Time Frame: Baseline, Weeks 24 and 48 ]

12.  Secondary:   C-reactive Protein (CRP) Level   [ Time Frame: Baseline, Weeks 24 and 48 ]

13.  Secondary:   Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Baseline, Weeks 24 and 48 ]

14.  Secondary:   HAQ-DI Score   [ Time Frame: Baseline, Weeks 24 and 48 ]

15.  Secondary:   Physical Function as Assessed by Short Form 36 (SF-36)   [ Time Frame: Screening, Weeks 24 and 48 ]

16.  Secondary:   SF-36 Mental Component Scores   [ Time Frame: Screening, Weeks 24 and 48 ]

17.  Secondary:   Modified Total Sharp-Genant Score (mTSS)   [ Time Frame: Screening and Weeks 24 and 48 ]

18.  Secondary:   Modified Sharp Radiographic Erosion Score (ES)   [ Time Frame: Screening, Weeks 24 and 48 ]

19.  Secondary:   Modified Sharp Radiographic Joint Space Narrowing Score (JSN)   [ Time Frame: Screening, Weeks 24 and 48 ]


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


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00462345     History of Changes
Other Study ID Numbers: ML20934
Study First Received: April 18, 2007
Results First Received: May 8, 2014
Last Updated: October 30, 2014
Health Authority: Korea: Food and Drug Administration