Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis (OLYMPUS)

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00087529
First received: July 9, 2004
Last updated: August 10, 2015
Last verified: August 2015
Results First Received: August 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Drug: placebo
Drug: rituximab

  Participant Flow
  Hide Participant Flow

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
Placebo Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
Rituximab Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.

Participant Flow:   Overall Study
    Placebo   Rituximab
STARTED   147   292 
COMPLETED   116   224 
NOT COMPLETED   31   68 
Death                1                0 
Adverse Event                0                8 
Pregnancy                0                1 
Lost to Follow-up                2                3 
Participant Decision                14                37 
Physician Decision                4                8 
Initiation of Excluded Therapy                0                1 
Participant Noncompliance                0                1 
Disease Progression                5                4 
Did Not Continue to Safety Follow-Up                5                5 



  Baseline Characteristics
  Hide Baseline Characteristics

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 randomized participants, with groups defined by treatment assigned at randomization.

Reporting Groups
  Description
Placebo Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
Rituximab Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Rituximab   Total 
Overall Participants Analyzed 
[Units: Participants]
 147   292   439 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.6  (8.69)   50.1  (9.02)   49.9  (8.90) 
Gender 
[Units: Participants]
     
Female   81   140   221 
Male   66   152   218 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Confirmed Disease Progression (CDP)   [ Time Frame: 96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression) ]

2.  Primary:   Percentage of Participants With CDP   [ Time Frame: 96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression) ]

3.  Secondary:   Change From Baseline to Week 96 in Total Volume of Transverse Relaxation Time (T2) Brain Lesions on Magnetic Resonance Imaging (MRI) Scan   [ Time Frame: At Baseline and Week 96 ]

4.  Secondary:   Change From Baseline to Week 96 in Brain Volume on MRI Scan   [ Time Frame: At Baseline and Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


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

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00087529     History of Changes
Other Study ID Numbers: U2786g
Study First Received: July 9, 2004
Results First Received: August 10, 2015
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration