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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00317941
Recruitment Status : Completed
First Posted : April 25, 2006
Results First Posted : October 21, 2013
Last Update Posted : October 21, 2013
Sponsor:
Information provided by:
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: Betaferon/Betaseron Drug: Rebif Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IFNB-1b 250 mcg (Betaseron) via Betaject
Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
 Drug: Betaferon/Betaseron
250ug administrated with Betaject
Experimental: IFNB-1b 250 mcg (Betaseron) via Betaject light
Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
 Drug: Betaferon/Betaseron
250ug administrated with Betaject light
Active Comparator: IFNB-1a 44 mcg (Rebif) via Rebiject II
Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
 Drug: Rebif
44ug administered with Rebiject II


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection [ Time Frame: 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

  2. Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection [ Time Frame: 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

  3. Mean Scores of Reaction After Injection Reported by Participants [ Time Frame: 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 :
  1. Percentage of Injection Sites With Pain Reported by Physicians [ Time Frame: Up to 3 months ]
  2. Percentage of Injection Sites Per Participant With Reaction Reported by Physicians [ Time Frame: Up to 3 months ]
  3. Percentage of Participants Without ISR Reported by Participants [ Time Frame: Up to 3 months assessed every 24 hours after each injection ]
  4. Percentage of Sites Developing a Severe Reaction 24 Hours After Injection [ Time Frame: 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

  5. Percentage of Sites Developing a Severe Reaction 48 Hours After Injection [ Time Frame: 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

  6. Percentage of Participants Without Pain Reported by Participants [ Time Frame: Up to 3 months assessed 24 hours after each injection ]
  7. Percentage of Injection Sites Without Pain Reported by Physicians [ Time Frame: Up to 3 months ]
  8. Percentage of Injection Sites Without Pain Reported by Participants [ Time Frame: Up to 3 months assessed 24 hours after each injection ]
  9. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection [ Time Frame: Immediately after injection ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  10. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection [ Time Frame: 30 min after injection ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  11. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection [ Time Frame: 1h after injection ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  12. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection [ Time Frame: 24h after injection ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  13. 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 ]
  14. Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants [ Time Frame: 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.



Other Outcome Measures:
  1. Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors [ Time Frame: Up to 3 months ]
    Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317941


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00317941    
Other Study ID Numbers: 91489
2005-005583-91 ( EudraCT Number )
308084 ( Other Identifier: company internal )
Avantage ( Other Identifier: company internal )
First Posted: April 25, 2006    Key Record Dates
Results First Posted: October 21, 2013
Last Update Posted: October 21, 2013
Last Verified: August 2013
Keywords provided by Bayer:
Multiple Sclerosis
RRMS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs