NCT01142557

Brief Summary

The aim of this case series was to document the effectiveness and compatibility of Rebif 44 or 22 µg in the therapy of the chronic multiple sclerosis (MS) under practical conditions on a large collection of subjects. In addition, the side effects possibly occurring in the initial phase of therapy and satisfaction of the subject as well as the treating doctor was also documented.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
522

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

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

June 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
Last Updated

July 11, 2014

Status Verified

June 1, 2010

Enrollment Period

1.4 years

First QC Date

June 10, 2010

Last Update Submit

July 9, 2014

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisRebifInterferon-beta

Outcome Measures

Primary Outcomes (1)

  • Assessment of the effectiveness and compatibility of Rebif 44 or 22 µg

    Baseline to 3 months

Secondary Outcomes (2)

  • Side effects occurring in the initial phase of therapy

    Baseline to 3 months

  • Satisfaction of the subject as well as the treating doctor

    Baseline to 3 months

Interventions

Interferon beta-1a (Rebif)DRUG

A dosage of 44 µg or 22 µg interferon beta-1a (Rebif) as subcutaneous self-injection three times a week was recommended for therapy of the included, suitable MS subjects after a creep-in phase of 4 weeks.

Also known as: Rebif

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with clinically safe diagnosis of a chronic MS and ability to walk were recorded in the case series.

You may qualify if:

  • Subjects with clinically safe diagnosis of a chronic MS and ability to walk (also with aids).

You may not qualify if:

  • Subjects with primary chronically progressive course of the MS
  • Pregnant or nursing female subjects
  • Subjects with severe depressions
  • Epilepsy subjects whose symptoms cannot be cured adequately with therapy
  • Subjects with existing systemic concurrent diseases (e.g. diabetes, heart, liver, kidney diseases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merck Serono GmbH

Darmstadt, 64289, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating 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

  • Norbert Zessack

    Merck Serono GmbH, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 11, 2010

Study Start

June 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

July 11, 2014

Record last verified: 2010-06

Locations

DE(1)