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

Phase 4

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: Betaferon/Betaseron; Drug: Rebif

• Registration Number: NCT00317941
• Lead Sponsor: Bayer

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-24
• Study First Submitted QC: 2006-04-24
• Study First Posted: 2006-04-25
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2013-05-24
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-15
• Last Update Submitted: 2013-08-15
• Results First Posted: 2013-10-21
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IFNB-1b 250 mcg (Betaseron) via Betaject light	Betaferon/Betaseron	Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
IFNB-1a 44 mcg (Rebif) via Rebiject II	Rebif	Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
IFNB-1b 250 mcg (Betaseron) via Betaject	Betaferon/Betaseron	Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject

Primary Outcome Measures

Name	Time	Method
Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection	Up to 3 months assessed every 24 hours after each injection	An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed
Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection	Up to 3 months assessed every 48 hours after each injection	An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed
Mean Scores of Reaction After Injection Reported by Participants	Up to 3 months assessed every 24 and 48 hours after injection	Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Without Pain Reported by Participants	Up to 3 months assessed 24 hours after each injection
Percentage of Injection Sites Without Pain Reported by Physicians	Up to 3 months
Percentage of Injection Sites Without Pain Reported by Participants	Up to 3 months assessed 24 hours after each injection
Percentage of Sites Developing a Severe Reaction 24 Hours After Injection	Up to 3 months assessed every 24 hours after each injection	An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis
Percentage of Sites Developing a Severe Reaction 48 Hours After Injection	Up to 3 months assessed every 48 hours after each injection	An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection	Immediately after injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection	30 min after injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection	1h after injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection	24h after injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants	Up to 3 months assessed every 24 hours after each injection
Percentage of Injection Sites With Pain Reported by Physicians	Up to 3 months
Percentage of Injection Sites Per Participant With Reaction Reported by Physicians	Up to 3 months
Percentage of Participants Without ISR Reported by Participants	Up to 3 months assessed every 24 hours after each injection
Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants	Up to 3 months assessed every 48 hours after each injection	if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction.; An injection site is seen as developing no reaction if the patient's score for this site is of a reaction intensity = 0.