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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
250ug administrated with Betaject
44ug administered with Rebiject II
250ug administrated with Betaject light
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
Time frame: Up to 3 months assessed every 24 hours after each injection
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
Time frame: Up to 3 months assessed every 48 hours after each injection
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
Time frame: Up to 3 months assessed every 24 and 48 hours after injection
Percentage of Injection Sites With Pain Reported by Physicians
Time frame: Up to 3 months
Percentage of Injection Sites Per Participant With Reaction Reported by Physicians
Time frame: Up to 3 months
Percentage of Participants Without ISR Reported by Participants
Time frame: Up to 3 months assessed every 24 hours after each injection
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
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Unnamed facility
Aix-en-Provence, France
Unnamed facility
Alkirch, France
Unnamed facility
Annecy, France
Unnamed facility
Aurillac, France
Unnamed facility
Belfort, France
Unnamed facility
Blaye, France
Unnamed facility
Bordeaux, France
Unnamed facility
Boulogne-sur-Mer, France
Unnamed facility
Brest, France
Unnamed facility
Brive-la-Gaillarde, France
...and 49 more locations
Time frame: Up to 3 months assessed every 24 hours after each injection
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
Time frame: Up to 3 months assessed every 48 hours after each injection
Percentage of Participants Without Pain Reported by Participants
Time frame: Up to 3 months assessed 24 hours after each injection
Percentage of Injection Sites Without Pain Reported by Physicians
Time frame: Up to 3 months
Percentage of Injection Sites Without Pain Reported by Participants
Time frame: Up to 3 months assessed 24 hours after each injection
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).
Time frame: Immediately after injection
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).
Time frame: 30 min after injection
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).
Time frame: 1h after injection
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).
Time frame: 24h after injection
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
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.
Time frame: Up to 3 months assessed every 48 hours after each injection