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

Bayer

Status and phase: Completed; Phase 4

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: Rebif; Drug: Betaferon/Betaseron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00317941

2005-005583-91 (EudraCT Number)

308084 (Other Identifier)

91489

Avantage (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

IFNB-1b 250 mcg (Betaseron) via Betaject

Experimental group

Description:

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

Treatment:

Drug: Betaferon/Betaseron

Drug: Betaferon/Betaseron

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

Experimental group

Description:

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

Treatment:

Drug: Betaferon/Betaseron

Drug: Betaferon/Betaseron

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

Active Comparator group

Description:

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

Treatment:

Drug: Rebif