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

The AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).

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.

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.

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.