NCT00534261

Brief Summary

This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a

Trial Health

90
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_4

Geographic Reach
3 countries

3 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

November 1, 1999

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

September 21, 2007

Last Update Submit

December 11, 2007

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple SclerosisAvonexInterferon beta-1a

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®).

    screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24

Secondary Outcomes (3)

  • Reproducibility of Quality of Life scales per language version

    months 18 and 24

  • Reliability of the Quality of Life scales per language version

    months 18 and 24

  • EDSS score throughout the study

    screening, Day -1, Months 12 and 24

Study Arms (1)

1

EXPERIMENTAL

patients received Avonex IM injections and be evaluated for quality of life criteria

Drug: Interferon beta-1a

Interventions

Interferon beta-1aDRUG

IM injection

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsing Remitting Multiple Sclerosis
  • Interferon naïve
  • Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics:
  • Subject has had relapsing MS for \> 1 year
  • Subject has had experienced 2 exacerbations in the last 2 years
  • Subject had an EDSS \[5\] score of \< 5.5
  • Subject was ambulant

You may not qualify if:

  • Diagnosis of MS defined as progressive
  • History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta
  • History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin
  • History of seizures within the 3 months prior to starting this study
  • History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the study
  • History of intolerance to interferons
  • Previous use of interferon beta
  • Female subjects who were pregnant or breast-feeding
  • For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Coordinating Research Site

Sijsele-Damme, 8340, Belgium

Location

Coordinating Research Site

Esch-sur-Alzette, 4011, Luxembourg

Location

Coordinating Research Site

Glasgow, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple 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

  • Biogen-Idec Investigator

    neurologyclinicaltrials@biogenidec.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 24, 2007

Study Start

November 1, 1999

Study Completion

February 1, 2004

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

LU(1)BE(1)GB(1)