Multiple Sclerosis, Relapsing-RemittingPhase 4NCT00780455

Rehabilitation Study in MS Patients

A Phase 4 study testing Interferon beta-1b, FRP within 15 days after randomization and Interferon beta-1b, FRP about 6 weeks after randomization in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 10 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Sclerosis, Relapsing-Remitting
What is being tested?: Interferon beta-1b, FRP within 15 days after randomization and Interferon beta-1b, FRP about 6 weeks after randomization
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 10 sitesFrance
Study dates: Oct 2008to Sep 2009
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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));
No relapse of multiple sclerosis (MS) in the last two months before the inclusion;
Walking patients having an Expanded Disability Status Scale (EDSS) score between > 1 and </= 4 at the inclusion visit;
Female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;

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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.

Who cannot join

Any contraindication to Betaferon as described in the SmPC of the product;
Patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

France10 sites

Study site
Avignon, 84025
Study site
Lille, 59037
Study site
Lomme, 59160
Study site
Montpellier, 34295
Study site
Mulhouse, 68051
Study site
Nîmes, 30029
Study site
Quimper, 29000
Study site
Reims, 51091
Study site
Rennes, Brittany Region, 35038
Study site
Toulouse, 31059

Other trials in France

About this study

Official title: Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®

Conditions: Multiple Sclerosis, Relapsing-Remitting
Being tested: Interferon beta-1b, FRP within 15 days after randomization, Interferon beta-1b, FRP about 6 weeks after randomization
Keywords: KineSEP, Rehabilitation, Betaferon
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

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

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 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.

Study groups in NCT00780455
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Interferon beta-1b, FRP about 6 weeks after randomization

What is being measured

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

Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.
Measured: Up to 6 minutes
Time of Discomfort Appearance
Measured: Up to 6 minutes
Distance of Discomfort Appearance
Measured: Up to 6 minutes
Rhythm Change During 6 Minutes Walking Test
Measured: Up to 6 minutes

Secondary outcomes (6)

Covered Distance Gain Between MR2 Visit and MR3 Visit
Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group "Interferon beta-1b, FRP within 15 days after randomization".
Measured: 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
The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.
Measured: At baseline and 12 weeks after MR1 visit
Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit
Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.
Measured: At baseline and 12 weeks after MR1 visit
Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits
Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group "Interferon beta-1b, FRP within 15 days after randomization".
Measured: 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)
FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.
Measured: From baseline to 12 weeks after MR1 visit
Quality of Life Assessed by Use of Self-questionnaire (SEP-59)
SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.
Measured: From baseline to 12 weeks after MR1 visit

Timeline

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

Oct 2008Sep 2009

First posted27 Oct 2008 (estimated)
Study startOct 2008
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00780455
Sponsor's protocol ID: 13089
Other IDs: 2006-006673-24, 308083
Status last verified: May 2015
First submitted: 28 May 2008
Last updated: 29 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®
ClinicalTrials.gov ID: NCT00780455
Acronym / sponsor ID: 13089
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: KineSEP, Rehabilitation, Betaferon
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 4 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 27 Oct 2008 (estimated)
Results: Posted 26 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Interferon beta-1b, FRP within 15 days after randomization	Experimental	Drug: Interferon beta-1b, FRP within 15 days after randomizationInterferon 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
Interferon beta-1b, FRP about 6 weeks after randomization	Experimental	Drug: Interferon beta-1b, FRP about 6 weeks after randomizationInterferon 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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));
No relapse of multiple sclerosis (MS) in the last two months before the inclusion;
Walking patients having an Expanded Disability Status Scale (EDSS) score between > 1 and </= 4 at the inclusion visit;

Key exclusion criteria (6 listed)

Any contraindication to Betaferon as described in the SmPC of the product;
Patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interferon beta-1b, FRP within 15 days after randomizationTreatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization	Drug	Interferon beta-1b, FRP within 15 days after randomization
Interferon beta-1b, FRP about 6 weeks after randomizationTreatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.	Drug	Interferon beta-1b, FRP about 6 weeks after randomization

Primary outcome

Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.
Time frame: Up to 6 minutes
Time of Discomfort Appearance
Time frame: Up to 6 minutes
Distance of Discomfort Appearance
Time frame: Up to 6 minutes
Rhythm Change During 6 Minutes Walking Test
Time frame: Up to 6 minutes

6 secondary outcomes

Covered Distance Gain Between MR2 Visit and MR3 Visit
Time frame: 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
Time frame: At baseline and 12 weeks after MR1 visit
Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit
Time frame: At baseline and 12 weeks after MR1 visit
Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits
Time frame: 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)
Time frame: From baseline to 12 weeks after MR1 visit
Quality of Life Assessed by Use of Self-questionnaire (SEP-59)
Time frame: From baseline to 12 weeks after MR1 visit

Results and safety

Results posted to the registry on 26 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interferon Beta-1b, FRP Within 15 Days After Randomization	2	2
Interferon Beta-1b, FRP About 6 Weeks After Randomization	2	2

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

Time frame: Up to 6 minutes

Population analysed: Due to the very low number of patients enrolled in the study, no statistical report was done.

Primary outcome: Time of Discomfort Appearance

Time frame: Up to 6 minutes

Population analysed: Due to the very low number of patients enrolled in the study, no statistical report was done.

Primary outcome: Distance of Discomfort Appearance

Time frame: Up to 6 minutes

Population analysed: Due to the very low number of patients enrolled in the study, no statistical report was done.

Primary outcome: Rhythm Change During 6 Minutes Walking Test

Time frame: Up to 6 minutes

Population analysed: Due to the very low number of patients enrolled in the study, no statistical report was done.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interferon Beta-1b, FRP Within 15 Days After Randomization	0 of 2 (0%)	2 of 2 (100%)	Not reported
Interferon Beta-1b, FRP About 6 Weeks After Randomization	0 of 2 (0%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to the very low number of patients enrolled in the study, no statistical report was done. Study was early terminated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 26 Feb 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?

Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test. (time frame: Up to 6 minutes). The study lists 4 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 NCT00780455.

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 29 May 2015.