Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00110396
First received: May 6, 2005
Last updated: August 2, 2013
Last verified: June 2010
Results First Received: April 30, 2010  
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: Multiple Sclerosis
Intervention: Biological: Interferon-beta-1a FBS-free/HSA-free

  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
Participants were enrolled from 25 Jan 2005 and attended the last visit on 16 April 2007. Two hundred and eighty two participants were screened for enrollment and 260 were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening phase of up to 28 days before the start of interferon-beta-1a treatment. There were 47 centres in: Argentina (5), Australia (4),Canada (1), Denmark (1),Ireland (2), Israel (2), Lithuania(2), Russia (10), Spain (4), Sweden (1), UK (5) and US (10). 1 additional centre in Australia screened 1 participant who was not enrolled into the trial.

Reporting Groups
  Description
Rebif New Formulation (RNF) Cohort Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week

Participant Flow:   Overall Study
    Rebif New Formulation (RNF) Cohort  
STARTED     260  
COMPLETED     224 [1]
NOT COMPLETED     36  
Adverse Event                 15  
Lost to Follow-up                 1  
Administration of plasmapheresis                 1  
Initiated mitoxantrone therapy                 1  
Lack of efficacy                 1  
Decided not to continue treatment                 1  
Patient non-compliance                 1  
Patient refused to continue                 1  
Patient refused to participate                 1  
Patient will                 1  
Patient's decision                 1  
Participation in MS vaccine study                 1  
Pregnancy                 1  
Pregnancy (Protocol violation)                 2  
Protocol violation                 2  
Patient refused to come back                 1  
The patient has refused                 2  
The patient has refused to visit site                 1  
Patient is to be administered copaxone                 1  
[1] 260 participants included in the Safety Population.207 completed treatment. 224 completed the trial



  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.
No text entered.

Reporting Groups
  Description
Rebif New Formulation (RNF) Cohort Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week

Baseline Measures
    Rebif New Formulation (RNF) Cohort  
Number of Participants  
[units: participants]
  260  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     260  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.9  ± 9.5  
Gender  
[units: participants]
 
Female     186  
Male     74  
Region of Enrollment  
[units: participants]
 
Argentina     14  
Australia     10  
Canada     4  
Denmark     4  
Ireland     4  
Israel     4  
Lithuania     20  
Russian Federation     134  
Spain     13  
Sweden     5  
United Kingdom     23  
United States     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.   [ Time Frame: 96 weeks ]

2.  Secondary:   Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study   [ Time Frame: 96 weeks ]

3.  Secondary:   Number of Participants With Binding Antibodies (BAb) at Week 96   [ Time Frame: 96 weeks ]


  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: Bettina Stubinski/Medical Responsible
Organization: Merck Serono SA
phone: +41224143396


Publications of Results:

Responsible Party: Susan Fischer, EMD Serono Inc
ClinicalTrials.gov Identifier: NCT00110396     History of Changes
Other Study ID Numbers: 25632
Study First Received: May 6, 2005
Results First Received: April 30, 2010
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration