NCT00493077

Brief Summary

This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_4 multiple-sclerosis

Timeline
Completed

Started May 2004

Geographic Reach
1 country

5 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, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

Enrollment Period

2 years

First QC Date

June 25, 2007

Last Update Submit

January 28, 2008

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisNeutralizing antibodiesSafetyLow immunogenicityinterferoninterferon-beta-1a

Outcome Measures

Primary Outcomes (1)

  • neutralizing antibody levels will be followed

    12 months

Secondary Outcomes (4)

  • Proportion of patients with NAb positive titre > 20.

    12 months

  • Relative change from baseline (screening) of NAb titre

    12 months

  • Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients

    12 months and as needed for relapses

  • The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.

    12 months

Study Arms (1)

1

EXPERIMENTAL
Drug: low immunogenic interferon-beta-1a

Interventions

low immunogenic interferon-beta-1aDRUG

dosage and frequency as per Biogen Idec protocol

Also known as: Avonex
1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria
  • Disability equivalent to an EDSS of 6.0 or less at screening
  • Neutralizing antibody titre \> 20 and \<500 in two consecutive NAb tests. One must be from before screening
  • previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment
  • A priori has been decided to be treated with AVONEX

You may not qualify if:

  • Is NAb positive on AVONEX
  • History of major depression
  • Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP \> 180/110 mmHg)
  • Renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit
  • Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
  • Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Gothenburg, 416 85, Sweden

Location

Coordinating Research Site

Huddinge, Sweden

Location

Research Site

Jönköping, 551 85, Sweden

Location

Research Site

Karlstad, 651 85, Sweden

Location

Research Site

Stockholm, 141 86, Sweden

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

  • Biogen-Idec Investigator

    neurologyclinicaltrials@biogenidec.com

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

May 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

SE(5)