Trial Condition(s):

Relapsing-Remitting Multiple Sclerosis

Safety study in relapsing-remitting multiple sclerosis (RRMS) patients receiving Betaferon or Rebif

Bayer Identifier:

91489

ClinicalTrials.gov Identifier:

NCT00317941

EudraCT Number:

2005-005583-91

Study Completed

Trial Purpose

The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

Inclusion Criteria
- Males or females
 - Age >= 18 years old
 - Patients after a first demyelinating event suggestive of MS (only for Betaferon) as well as patients with a definite diagnosis of RRMS (Betaferon et Rebif)
 - First justified prescription of one interferon beta by subcutaneous route (as described in Summary of Product Characteristics [SmPC] of Betaferon or Rebif)
 - Females of child-bearing potential must agree to practice adequate contraceptive methods over the duration of the study (not applicable for men)
 - Patient can follow and comply with all study procedures of the trial protocol
 - Laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-GT, full blood count and differential white blood cell count [WBC]) must be available and the results must be normal.
 - Written informed consent
Exclusion Criteria
- Any contraindication to the prescription of Betaferon or Rebif, as described in the SmPC of products:
 -- Pregnancy or lactation
 -- Known hypersensitivity to natural or recombinant interferon beta, to mannitol, to human albumin or any other excipients used
 -- History of severe depression or suicide attempt or current suicidal ideation.
 -- Patient with decompensated liver disease
 -- Epilepsy not adequately controlled by treatment
 - Patient previously included in this study.
 - Patient previously treated by sub-cutaneous route with either Betaferon or Rebif.
 - Participation in any clinical trial within the past 30 days involving the investigational drug intake.
 - Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.

Trial Summary

Enrollment Goal
220
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Aix en Provence, France, 13616

Status
Completed
 
Locations

Investigative Site

Belfort, France

Status
Completed
 
Locations

Investigative Site

Blaye, France

Status
Completed
 
Locations

Investigative Site

Bordeaux, France, 33000

Status
Completed
 
Locations

Investigative Site

Brest Cedex, France

Status
Completed
 
Locations

Investigative Site

Brive La Gaillarde, France, 19100

Status
Completed
 
Locations

Investigative Site

Carcassonne, France

Status
Completed
 
Locations

Investigative Site

Champigny sur Marne, France

Status
Completed
 
Locations

Investigative Site

Colmar, France

Status
Completed
 
Locations

Investigative Site

Créteil, France, 94000

Status
Completed
 
Locations

Investigative Site

Dijon, France

Status
Completed
 
Locations

Investigative Site

Dunkerque, France, 59140

Status
Completed
 
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Investigative Site

Evry, France

Status
Completed
 
Locations

Investigative Site

Le Mans, France, 72000

Status
Completed
 
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Investigative Site

Lomme Cedex, France

Status
Completed
 
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Investigative Site

Montpellier Cedex 5, France

Status
Completed
 
Locations

Investigative Site

Nancy, France, 54000

Status
Completed
 
Locations

Investigative Site

Nancy Cedex, France

Status
Completed
 
Locations

Investigative Site

Nice, France

Status
Completed
 
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Investigative Site

Paris, France

Status
Completed
 
Locations

Investigative Site

Perpignan, France, 66000

Status
Completed
 
Locations

Investigative Site

Quimper, France, 29000

Status
Completed
 
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Investigative Site

Quimper Cedex, France

Status
Completed
 
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Investigative Site

Rennes, France

Status
Completed
 
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Investigative Site

Alkirch, France

Status
Completed
 
Locations

Investigative Site

Annecy Cedex, France, 74011

Status
Completed
 
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Investigative Site

Aurillac, France, 15000

Status
Completed
 
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Investigative Site

Boulogne sur Mer, France, 62321

Status
Completed
 
Locations

Investigative Site

Castelnau le Lez, France, 34170

Status
Completed
 
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Investigative Site

Chamaliÿres, France

Status
Completed
 
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Investigative Site

Corbeil Essones Cedex, France

Status
Completed
 
Locations

Investigative Site

Dreux, France

Status
Completed
 
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Investigative Site

Elbeuf, France

Status
Completed
 
Locations

Investigative Site

Evreux Cedex, France, 27023

Status
Completed
 
Locations

Investigative Site

La Seyne sur Mer, France, 83500

Status
Completed
 
Locations

Investigative Site

Le Mans Cedex, France

Status
Completed
 
Locations

Investigative Site

Libourne Cedex, France, 33505

Status
Completed
 
Locations

Investigative Site

Lille, France

Status
Completed
 
Locations

Investigative Site

Lyon, France

Status
Completed
 
Locations

Investigative Site

Marseille, France, 13006

Status
Completed
 
Locations

Investigative Site

Montpellier, France

Status
Completed
 
Locations

Investigative Site

Nantes, France, 44000

Status
Completed
 
Locations

Investigative Site

Nimes Cedex 9, France, 30900

Status
Completed
 
Locations

Investigative Site

Pau, France

Status
Completed
 
Locations

Investigative Site

Poissy, France

Status
Completed
 
Locations

Investigative Site

Quimper, France

Status
Completed
 
Locations

Investigative Site

Reims, France

Status
Completed
 
Locations

Investigative Site

Rouen, France

Status
Completed
 
Locations

Investigative Site

Rueil Malmaison, France

Status
Completed
 
Locations

Investigative Site

Saint Quentin, France

Status
Completed
 
Locations

Investigative Site

St Lÿ, France, 50000

Status
Completed
 
Locations

Investigative Site

St Omer, France, 62505

Status
Completed
 
Locations

Investigative Site

Toulouse, France, 31400

Status
Completed
 
Locations

Investigative Site

Tourcoing, France

Status
Completed
 
Locations

Investigative Site

Vesoul, France, 70000

Status
Completed
 
Locations

Investigative Site

Saint Herblain, France, 44800

Status
Completed
 
Locations

Investigative Site

St Etienne, France

Status
Completed
 
Locations

Investigative Site

Strasbourg, France

Status
Completed
 
Locations

Investigative Site

Trelaze, France

Status
Completed
 
Locations

Investigative Site

Vendome, France

Status
Completed
 
Locations

Investigative Site

Vichy, France

Status
Completed
 

Trial Design