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

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Betaferon/Betaseron
Rebif
Betaferon/Betaseron
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, RRMS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

IFNB-1b 250 mcg (Betaseron) via Betaject

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

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 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
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
Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis

Secondary Outcome Measures

Percentage of Injection Sites With Pain Reported by Physicians
Percentage of Injection Sites Per Participant With Reaction Reported by Physicians
Percentage of Participants Without ISR Reported by Participants
Percentage of Sites Developing a Severe Reaction 24 Hours After 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
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 Participants Without Pain Reported by Participants
Percentage of Injection Sites Without Pain Reported by Physicians
Percentage of Injection Sites Without Pain Reported by Participants
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 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
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
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
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
Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants
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.

Full Information

First Posted
April 24, 2006
Last Updated
August 15, 2013
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00317941
Brief Title
Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
Official Title
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®).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, RRMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IFNB-1b 250 mcg (Betaseron) via Betaject
Arm Type
Experimental
Arm Description
Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
Arm Title
IFNB-1b 250 mcg (Betaseron) via Betaject light
Arm Type
Experimental
Arm Description
Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
Arm Title
IFNB-1a 44 mcg (Rebif) via Rebiject II
Arm Type
Active Comparator
Arm Description
Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
Intervention Type
Drug
Intervention Name(s)
Betaferon/Betaseron
Intervention Description
250ug administrated with Betaject
Intervention Type
Drug
Intervention Name(s)
Rebif
Intervention Description
44ug administered with Rebiject II
Intervention Type
Drug
Intervention Name(s)
Betaferon/Betaseron
Intervention Description
250ug administrated with Betaject light
Primary Outcome Measure Information:
Title
Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection
Description
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
Time Frame
Up to 3 months assessed every 24 hours after each injection
Title
Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection
Description
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
Time Frame
Up to 3 months assessed every 48 hours after each injection
Title
Mean Scores of Reaction After Injection Reported by Participants
Description
Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis
Time Frame
Up to 3 months assessed every 24 and 48 hours after injection
Secondary Outcome Measure Information:
Title
Percentage of Injection Sites With Pain Reported by Physicians
Time Frame
Up to 3 months
Title
Percentage of Injection Sites Per Participant With Reaction Reported by Physicians
Time Frame
Up to 3 months
Title
Percentage of Participants Without ISR Reported by Participants
Time Frame
Up to 3 months assessed every 24 hours after each injection
Title
Percentage of Sites Developing a Severe Reaction 24 Hours After Injection
Description
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
Time Frame
Up to 3 months assessed every 24 hours after each injection
Title
Percentage of Sites Developing a Severe Reaction 48 Hours After Injection
Description
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
Time Frame
Up to 3 months assessed every 48 hours after each injection
Title
Percentage of Participants Without Pain Reported by Participants
Time Frame
Up to 3 months assessed 24 hours after each injection
Title
Percentage of Injection Sites Without Pain Reported by Physicians
Time Frame
Up to 3 months
Title
Percentage of Injection Sites Without Pain Reported by Participants
Time Frame
Up to 3 months assessed 24 hours after each injection
Title
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection
Description
Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Time Frame
Immediately after injection
Title
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection
Description
Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Time Frame
30 min after injection
Title
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection
Description
Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Time Frame
1h after injection
Title
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection
Description
Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Time Frame
24h after injection
Title
Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants
Time Frame
Up to 3 months assessed every 24 hours after each injection
Title
Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants
Description
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.
Time Frame
Up to 3 months assessed every 48 hours after each injection
Other Pre-specified Outcome Measures:
Title
Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors
Description
Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
City
Alkirch
Country
France
City
Annecy Cedex
ZIP/Postal Code
74011
Country
France
City
Aurillac
ZIP/Postal Code
15000
Country
France
City
Belfort
Country
France
City
Blaye
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Boulogne sur Mer
ZIP/Postal Code
62321
Country
France
City
Brest Cedex
Country
France
City
Brive La Gaillarde
ZIP/Postal Code
19100
Country
France
City
Carcassonne
Country
France
City
Castelnau le Lez
ZIP/Postal Code
34170
Country
France
City
Chamaliÿres
Country
France
City
Champigny sur Marne
Country
France
City
Colmar
Country
France
City
Corbeil Essones Cedex
Country
France
City
Créteil
ZIP/Postal Code
94000
Country
France
City
Dijon
Country
France
City
Dreux
Country
France
City
Dunkerque
ZIP/Postal Code
59140
Country
France
City
Elbeuf
Country
France
City
Evreux Cedex
ZIP/Postal Code
27023
Country
France
City
Evry
Country
France
City
La Seyne sur Mer
ZIP/Postal Code
83500
Country
France
City
Le Mans Cedex
Country
France
City
Le Mans
ZIP/Postal Code
72000
Country
France
City
Libourne Cedex
ZIP/Postal Code
33505
Country
France
City
Lille
Country
France
City
Lomme Cedex
Country
France
City
Lyon
Country
France
City
Marseille
ZIP/Postal Code
13006
Country
France
City
Montpellier Cedex 5
Country
France
City
Montpellier
Country
France
City
Nancy Cedex
Country
France
City
Nancy
ZIP/Postal Code
54000
Country
France
City
Nantes
ZIP/Postal Code
44000
Country
France
City
Nice
Country
France
City
Nimes Cedex 9
ZIP/Postal Code
30900
Country
France
City
Paris
Country
France
City
Pau
Country
France
City
Perpignan
ZIP/Postal Code
66000
Country
France
City
Poissy
Country
France
City
Quimper Cedex
Country
France
City
Quimper
ZIP/Postal Code
29000
Country
France
City
Quimper
Country
France
City
Reims
Country
France
City
Rennes
Country
France
City
Rouen
Country
France
City
Rueil Malmaison
Country
France
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
City
Saint Quentin
Country
France
City
St Etienne
Country
France
City
St Lÿ
ZIP/Postal Code
50000
Country
France
City
St Omer
ZIP/Postal Code
62505
Country
France
City
Strasbourg
Country
France
City
Toulouse
ZIP/Postal Code
31400
Country
France
City
Tourcoing
Country
France
City
Trelaze
Country
France
City
Vendome
Country
France
City
Vesoul
ZIP/Postal Code
70000
Country
France
City
Vichy
Country
France

12. IPD Sharing Statement

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

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