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A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02097745
First Posted: March 27, 2014
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biogen
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: October 8, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: methotrexate
Drug: rituximab [MabThera/Rituxan]

  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 Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.

Participant Flow:   Overall Study
    Rituximab
STARTED   335 [1] 
COMPLETED   157 
NOT COMPLETED   178 
Adverse Event                25 
Death                16 
Failure to Return                14 
Administrative/Other                27 
Reason Not Specified                96 
[1] Six participants did not receive any treatment and were not included in any analyses.



  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.
Safety population: All participants who received any part of an infusion of study medication.

Reporting Groups
  Description
Rituximab Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.

Baseline Measures
   Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 335 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.1  (11.81) 
Gender 
[Units: Participants]
 
Female   273 
Male   62 


  Outcome Measures
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1.  Primary:   Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

2.  Secondary:   Change From Baseline in the Disease Activity Score 28 (DAS28)   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

3.  Secondary:   Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

4.  Secondary:   Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

5.  Secondary:   Change From Baseline in the American College of Rheumatology n (ACRn) Response   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

6.  Secondary:   Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

7.  Secondary:   Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

8.  Secondary:   Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score   [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

9.  Secondary:   Percentage of Participants With no Radiographic Progression From Baseline to Year 5   [ Time Frame: Baseline to Year 5 ]

10.  Secondary:   Change From Baseline in the Total Genant-modified Sharp Score at Year 5   [ Time Frame: Baseline to Year 5 ]

11.  Secondary:   Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5   [ Time Frame: Baseline to Year 5 ]

12.  Secondary:   Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5   [ Time Frame: Baseline to Year 5 ]

13.  Secondary:   Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5   [ Time Frame: Baseline to Year 5 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02097745     History of Changes
Obsolete Identifiers: NCT00468377
Other Study ID Numbers: WA17531
First Submitted: March 20, 2014
First Posted: March 27, 2014
Results First Submitted: October 8, 2014
Results First Posted: November 7, 2014
Last Update Posted: November 3, 2016