Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients
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®).
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFNB-1b 250 Mcg (Betaseron) | 31 Percentage of sites | 16 | |
| IFNB-1a 44 Mcg (Rebif) Via Rebiject II | 37 Percentage of sites | 16 |
IFNB-1b 250 Mcg (Betaseron)
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFNB-1b 250 Mcg (Betaseron) | 27 Percentage of sites | 16 | |
| IFNB-1a 44 Mcg (Rebif) Via Rebiject II | 41 Percentage of sites | 16 |
IFNB-1b 250 Mcg (Betaseron)
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Mean Scores of Reaction After Injection Reported by Participants
Up to 3 months assessed every 24 and 48 hours after injection
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| IFNB-1b 250 Mcg (Betaseron) | 0.368 Scores on a scale | 3.11 (Standard Deviation) | 16 |
| IFNB-1a 44 Mcg (Rebif) Via Rebiject II | 0.500 Scores on a scale | 3.45 (Standard Deviation) | 16 |
IFNB-1b 250 Mcg (Betaseron)
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| IFNB-1b 250 Mcg (Betaseron) | 150 | 2 (1.3%) | |
| IFNB-1a 44 Mcg (Rebif) Via Rebiject II | 65 | 1 (1.5%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
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
SafetyPercentage 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
SafetyMean Scores of Reaction After Injection Reported by Participants
Up to 3 months assessed every 24 and 48 hours after injection
Other measures (14)
Percentage of Injection Sites With Pain Reported by Physicians
Up to 3 months
PainSafetyPercentage of Injection Sites Per Participant With Reaction Reported by Physicians
Up to 3 months
SafetyPercentage of Participants Without ISR Reported by Participants
Up to 3 months assessed every 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
Percentage of Sites Developing a Severe Reaction 48 Hours After Injection
Up to 3 months assessed every 48 hours after each injection
Percentage of Participants Without Pain Reported by Participants
Up to 3 months assessed 24 hours after each injection
PainPercentage of Injection Sites Without Pain Reported by Physicians
Up to 3 months
PainSafetyPercentage of Injection Sites Without Pain Reported by Participants
Up to 3 months assessed 24 hours after each injection
PainSafetyMean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection
Immediately after injection
PainMean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection
30 min after injection
Pain
Who could take part
Relapsing MS · 18 to 55
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2006
Main results due
Apr 2008
Finished
Apr 2008
Results posted
Oct 2013