Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif

NCT ID: NCT00317941

Last Updated: 2013-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-04-30

Brief Summary

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.

Detailed Description

Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de sclérose en plaques.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; RRMS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IFNB-1b 250 mcg (Betaseron) via Betaject

Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject

Group Type: EXPERIMENTAL

Betaferon/Betaseron

Intervention Type: DRUG

250ug administrated with Betaject

IFNB-1b 250 mcg (Betaseron) via Betaject light

Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light

Group Type: EXPERIMENTAL

Betaferon/Betaseron

Intervention Type: DRUG

250ug administrated with Betaject light

IFNB-1a 44 mcg (Rebif) via Rebiject II

Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II

Group Type: ACTIVE_COMPARATOR

Rebif

Intervention Type: DRUG

44ug administered with Rebiject II

Interventions

Betaferon/Betaseron

250ug administrated with Betaject

Intervention Type: DRUG

Rebif

44ug administered with Rebiject II

Intervention Type: DRUG

Betaferon/Betaseron

250ug administrated with Betaject light

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Aix-en-Provence, , France

Alkirch, , France

Annecy, , France

Aurillac, , France

Belfort, , France

Blaye, , France

Bordeaux, , France

Boulogne-sur-Mer, , France

Brest, , France

Brive-la-Gaillarde, , France

Carcassonne, , France

Castelnau-le-Lez, , France

Chamaliÿres, , France

Champigny-sur-Marne, , France

Colmar, , France

Corbeil Essones Cedex, , France

Créteil, , France

Dijon, , France

Dreux, , France

Dunkirk, , France

Elbeuf, , France

Évreux, , France

Évry, , France

La Seyne-sur-Mer, , France

Le Mans, , France

Le Mans, , France

Libourne, , France

Lille, , France

Lomme, , France

Lyon, , France

Marseille, , France

Montpellier, , France

Nancy, , France

Nancy, , France

Nantes, , France

Nice, , France

Nîmes, , France

Paris, , France

Pau, , France

Perpignan, , France

Poissy, , France

Quimper, , France

Quimper, , France

Reims, , France

Rennes, , France

Rouen, , France

Rueil-Malmaison, , France

Saint Lÿ, , France

Saint-Etienne, , France

Saint-Herblain, , France

Saint-Omer, , France

Saint-Quentin, , France

Strasbourg, , France

Toulouse, , France

Tourcoing, , France

Trélazé, , France

Vendôme, , France

Vesoul, , France

Vichy, , France

Countries

France

Other Identifiers

2005-005583-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

308084

Identifier Type: OTHER

Identifier Source: secondary_id

Avantage

Identifier Type: OTHER

Identifier Source: secondary_id

91489

Identifier Type: -

Identifier Source: org_study_id