Rehabilitation Study in MS Patients

Bayer

Status and phase: Terminated; Phase 4

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Interferon beta-1b, FRP about 6 weeks after randomization; Drug: Interferon beta-1b, FRP within 15 days after randomization

Study type: Interventional

Funder types: Industry

Identifiers

NCT00780455

308083 (Other Identifier)

2006-006673-24 (EudraCT Number)

13089

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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