NCT00780455

Brief Summary

Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

February 26, 2013

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

May 28, 2008

Results QC Date

January 22, 2013

Last Update Submit

May 8, 2015

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

KineSEPRehabilitationBetaferon

Outcome Measures

Primary Outcomes (4)

  • Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.

    Up to 6 minutes

  • Time of Discomfort Appearance

    Up to 6 minutes

  • Distance of Discomfort Appearance

    Up to 6 minutes

  • Rhythm Change During 6 Minutes Walking Test

    Up to 6 minutes

Secondary Outcomes (6)

  • Covered Distance Gain Between MR2 Visit and MR3 Visit

    At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)

  • Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit

    At baseline and 12 weeks after MR1 visit

  • Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit

    At baseline and 12 weeks after MR1 visit

  • Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits

    At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)

  • Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)

    From baseline to 12 weeks after MR1 visit

  • +1 more secondary outcomes

Study Arms (2)

Interferon beta-1b, FRP within 15 days after randomization

EXPERIMENTAL

Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization

Drug: Interferon beta-1b, FRP within 15 days after randomization

Interferon beta-1b, FRP about 6 weeks after randomization

EXPERIMENTAL

Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization

Drug: Interferon beta-1b, FRP about 6 weeks after randomization

Interventions

Interferon beta-1b, FRP within 15 days after randomizationDRUG

Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization

Interferon beta-1b, FRP within 15 days after randomization
Interferon beta-1b, FRP about 6 weeks after randomizationDRUG

Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.

Interferon beta-1b, FRP about 6 weeks after randomization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and Male patients aged 18 and more;
  • Confirmed diagnosis of RRMS according to the MacDonald or Poser criteria;
  • First indication for Betaferon treatment (as described in Summary of Product Characteristics (SmPC));
  • Female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
  • Patient can follow all the study and comply with all procedures of the trial protocol
  • Laboratory evaluations (i.e. evaluation of hepatic enzymes gammaGT, full blood count and differential white blood cell \[WBC\]) must be available and the results must be normal;
  • Written informed consent.

You may not qualify if:

  • Any contraindication to Betaferon as described in the SmPC of the product;
  • Patient previously included in this study;
  • Patient previously treated within the past 3 months with Rebif, Avonex or Copaxone;
  • Patient previously treated within the past 12 months with Betaferon;
  • Participation in any clinical trial within the past 30 days involving the investigational drug intake.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Rennes, Brittany Region, 35038, France

Location

Unknown Facility

Avignon, 84025, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Lomme, 59160, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Mulhouse, 68051, France

Location

Unknown Facility

Nîmes, 30029, France

Location

Unknown Facility

Quimper, 29000, France

Location

Unknown Facility

Reims, 51091, France

Location

Unknown Facility

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Limitations and Caveats

Due to the very low number of patients enrolled in the study, no statistical report was done. Study was early terminated.

Results Point of Contact

Title
Medical Affiars Therapeutic Area Head
Organization
Bayer Healthcare AG
clinical-trials-contact@bayerhealthcare.com

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2008

First Posted

October 27, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 29, 2015

Results First Posted

February 26, 2013

Record last verified: 2015-05

Locations

FR(10)