NCT01075880

Brief Summary

The study is planned to evaluate the cognitive functions in subjects with RRMS treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 6, 2013

Status Verified

September 1, 2013

Enrollment Period

4.1 years

First QC Date

February 24, 2010

Last Update Submit

September 5, 2013

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-RemittingRebifInterferon beta-1a

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with decreased/increased/stable cognition status (PASAT)

    Baseline vs Month 6 - 12 - 24

Secondary Outcomes (8)

  • Percentage of subjects with decreased/increased/stable fatigue (FDS)

    Baseline vs Month 6- 12 - 24

  • Relationship between the cognition status, the fatigue status and the EDSS status

    Baseline, Month 6- 12 - 24

  • Relationship between the Rebif dosage used with cognition and fatigue status

    Baseline, Month 6- 12 - 24

  • Proportion of relapse-free subjects

    Month 3 - 6 - 12 - 24

  • Proportion of subjects with defined EDSS changes (decrease; no change; increase of 0.5 - 1.0; 1.5 - 2.0; 2.5 - 3.0; 3.0 or more points, respectively)

    Month 6 - 12 - 24

  • +3 more secondary outcomes

Interventions

Rebif (Interferon beta-1a)DRUG

The treatment to be administered is interferon beta-1a on prescription, used as per SmPC, i.e. both doses 22 and 44 mcg s.c. tiw, and the titration pack 8.8 mcg and 22 mcg s.c. tiw when initiating the therapy.

Also known as: Rebif

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with RRMS prescribed with Rebif across 14 centres in Czech Republic.

You may qualify if:

  • Subjects diagnosed with RRMS
  • Subjects eligible for treatment with Rebif as per SmPC, the Czech local guidelines and the actual Health insurance policy.
  • Subjects 18-65 years of age
  • Subjects with EDSS score \< 4
  • Subjects who are willing and able to give informed consent

You may not qualify if:

  • Treatment with Rebif for more than 24 months prior the informed consent form has been obtained.
  • Subjects with history of hypersensitivity to natural or recombinant interferon-β, or to any excipients
  • Female subject who is pregnant or breast feeding and/or planning to become pregnant
  • Subjects with current severe depression and/or suicidal ideation
  • Any contraindication for Rebif therapy as per SmPC
  • Subjects with severe disability and/or any neurologic or psychiatric condition that may interfere with test performance
  • Prior treatment with interferon beta-1a i.m. or interferon beta-1b or glatiramer acetate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Neurologicka klinika FNBB

Brno, Czechia

Location

Neurologicka klinika, Fakultní nemocnice U Sv. Anny

Brno, Czechia

Location

Neurologicke oddeleni KN.

České Budějovice, Czechia

Location

Neurologicka klinika Fakultní nemocnice

Hradec Králové, Czechia

Location

Neurologicka klinika Fakultní nemocnice

Motol, Czechia

Location

Neurologicka klinika, Fakultní nemocnice

Olomouc, Czechia

Location

Neurologicka klinika Fakultní nemocnice

Ostrava, Czechia

Location

Neurologicke oddeleni KN

Pardubice, Czechia

Location

Neurologicka klinika Fakultní nemocnice

Pilsen, Czechia

Location

Neurologicka klinika FNKV

Prague, Czechia

Location

Neurologicka klinika, Fakultní Thomayerovy nemocnice

Prague, Czechia

Location

Neurologicke oddeleni NsP

Teplice, Czechia

Location

Neurologicke oddeleni, Baťova nemocnice

Zlín, Czechia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a

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

Study Officials

  • Medical Responsible

    Merck spol.s.r.o., Czech Republic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

May 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 6, 2013

Record last verified: 2013-09

Locations

CZ(13)