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Relapsing-remitting Multiple SclerosisPhase 4NCT00317941

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

A Phase 4 study testing Betaferon/Betaseron and Rebif in people with Relapsing-remitting Multiple Sclerosis, run by Bayer at 59 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing-remitting Multiple Sclerosis
What is being tested?
Betaferon/Betaseron and Rebif
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
59 sitesFrance
Study dates
Mar 2006to Apr 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

France59 sites

  • Study site

    Aix-en-Provence, 13616

  • Study site

    Alkirch

  • Study site

    Annecy, 74011

  • Study site

    Aurillac, 15000

  • Study site

    Belfort

  • Study site

    Blaye

  • Study site

    Bordeaux, 33000

  • Study site

    Boulogne-sur-Mer, 62321

  • Study site

    Brest

  • Study site

    Brive-la-Gaillarde, 19100

  • Study site

    Carcassonne

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Chamaliÿres

  • Study site

    Champigny-sur-Marne

  • Study site

    Colmar

  • Study site

    Corbeil Essones Cedex

  • Study site

    Créteil, 94000

  • Study site

    Dijon

  • Study site

    Dreux

  • Study site

    Dunkirk, 59140

  • Study site

    Elbeuf

  • Study site

    Évreux, 27023

  • Study site

    Évry

  • Study site

    La Seyne-sur-Mer, 83500

  • Study site

    Le Mans, 72000

  • Study site

    Le Mans

  • Study site

    Libourne, 33505

  • Study site

    Lille

  • Study site

    Lomme

  • Study site

    Lyon

  • Study site

    Marseille, 13006

  • Study site

    Montpellier

  • Study site

    Nancy, 54000

  • Study site

    Nancy

  • Study site

    Nantes, 44000

  • Study site

    Nice

  • Study site

    Nîmes, 30900

  • Study site

    Paris

  • Study site

    Pau

  • Study site

    Perpignan, 66000

  • Study site

    Poissy

  • Study site

    Quimper, 29000

  • Study site

    Quimper

  • Study site

    Reims

  • Study site

    Rennes

  • Study site

    Rouen

  • Study site

    Rueil-Malmaison

  • Study site

    Saint Lÿ, 50000

  • Study site

    Saint-Etienne

  • Study site

    Saint-Herblain, 44800

  • Study site

    Saint-Omer, 62505

  • Study site

    Saint-Quentin

  • Study site

    Strasbourg

  • Study site

    Toulouse, 31400

  • Study site

    Tourcoing

  • Study site

    Trélazé

  • Study site

    Vendôme

  • Study site

    Vesoul, 70000

  • Study site

    Vichy

Other trials in France

About this study

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®).

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.

Read the 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.

Being tested
Betaferon/Betaseron, Rebif
Keywords
Multiple Sclerosis, RRMS
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Betaferon/BetaseronDrug

    250ug administrated with Betaject

  • RebifDrug

    44ug administered with Rebiject II

  • Betaferon/BetaseronDrug

    250ug administrated with Betaject light

Study groups in NCT00317941
Study groupRoleWhat they receive
IFNB-1b 250 mcg (Betaseron) via BetajectExperimentalInterferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
Receives: Drug: Betaferon/Betaseron
IFNB-1b 250 mcg (Betaseron) via Betaject lightExperimentalInterferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
Receives: Drug: Betaferon/Betaseron
IFNB-1a 44 mcg (Rebif) via Rebiject IIActive comparatorInterferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
Receives: Drug: Rebif

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 3 months assessed every 24 hours after each injection

  2. 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

    Measured: Up to 3 months assessed every 48 hours after each injection

  3. 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

    Measured: Up to 3 months assessed every 24 and 48 hours after injection

Secondary outcomes (14)

  1. Percentage of Injection Sites With Pain Reported by Physicians

    Measured: Up to 3 months

  2. Percentage of Injection Sites Per Participant With Reaction Reported by Physicians

    Measured: Up to 3 months

  3. Percentage of Participants Without ISR Reported by Participants

    Measured: Up to 3 months assessed every 24 hours after each injection

  4. 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

    Measured: Up to 3 months assessed every 24 hours after each injection

  5. 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

    Measured: Up to 3 months assessed every 48 hours after each injection

  6. Percentage of Participants Without Pain Reported by Participants

    Measured: Up to 3 months assessed 24 hours after each injection

  7. Percentage of Injection Sites Without Pain Reported by Physicians

    Measured: Up to 3 months

  8. Percentage of Injection Sites Without Pain Reported by Participants

    Measured: 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

    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

    Measured: Immediately after injection

  10. 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).

    Measured: 30 min after injection

  11. 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).

    Measured: 1h after injection

  12. 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).

    Measured: 24h after injection

  13. Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants

    Measured: Up to 3 months assessed every 24 hours after each injection

  14. 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.

    Measured: Up to 3 months assessed every 48 hours after each injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317941
Sponsor's protocol ID
91489
Other IDs
2005-005583-91, 308084, Avantage, 2005
Status last verified
Aug 2013
First submitted
24 Apr 2006
Last updated
21 Oct 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Betaferon/Betaseron and Rebif in people with Relapsing-remitting Multiple Sclerosis, run by Bayer at 59 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2013.

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