Safety Study in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00317941

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.

Condition	Intervention	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: Betaferon/Betaseron Drug: Rebif	Phase IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferons Interferon beta Interferon-beta Interferon beta 1a Interferon beta-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Etude de Phase IV, Multicentrique, randomisée, Ouverte, Comparant Les réactions et la Douleur Aux Sites d'Injection après Administration Sous-cutanée d'interféron bêta-1b (Betaferon) ou interféron bêta-1a (Rebif) Pendant la période de Trois Mois d'Initiation de la thérapie Chez Des Patients à Haut Risque de développer Une sclérose en Plaques ou Atteints d'Une Forme récurrente/rémittente de sclérose en Plaques AVANTAGE: Analyse Comparative Des réactions Aux Sites d'Injection surVenues après AdministratioN de BeTAferon250 µG ou REbif 44 µg.

Further study details as provided by Bayer:

Primary Outcome Measures:

To compare intensity and frequency of injection site reaction and injection site pain after subcutaneous administration of Betaferon or Rebif during the first three months after the initiation of treatment [ Time Frame: 24h and 48h after each injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Comparison between autoinjectors and products [ Time Frame: 24h and 48h after each injection ] [ Designated as safety issue: Yes ]

Enrollment:	220
Study Start Date:	March 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Betaferon/Betaseron 250ug administrated with Betaject
2: Active Comparator	Drug: Rebif 44ug administered with Rebiject II
3: Active Comparator	Drug: Betaferon/Betaseron 250ug administrated with Betaject light

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317941

Show 61 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91489, EudraCT 2005-005583-91, 308084, Avantage
Study First Received:	April 24, 2006
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00317941
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Bayer:

Multiple Sclerosis
RRMS

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta-1b
Interferon beta 1a

Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009