NCT00037102

Brief Summary

The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4 multiple-sclerosis

Timeline
Completed

Started Jul 2001

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

July 1, 2001

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

2.4 years

First QC Date

May 15, 2002

Last Update Submit

April 10, 2018

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisRelapsingMethotrexateAVONEXinterferon beta 1ademyelinatingautoimmune

Interventions

interferon beta 1aDRUG
methotrexateDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment: * Between the ages of 18 and 60 years, inclusive. * Diagnosis of clinically definite relapsing MS. * Must have been on AVONEX® therapy for at least six months. * Brain MRI scans demonstrating lesions consistent with MS. * Subject must have had at least one clinical exacerbation in the last year, and this must have occurred after having been on AVONEX® therapy for at least six to twelve (6-12) months. A clinical exacerbation is defined as a decrease of 0.1 in the MSFC composite or any of the subset domains scores administered 3 months apart. * Give written informed consent prior to any testing under this protocol, including screening tests and evaluation that are not considered part of the subject's routine care. To be eligible for treatment with methotrexate, subjects must have evidence for MS disease activity on their baseline screening MRI.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisRecurrence

Interventions

Interferon beta-1aMethotrexate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Vernon D ROWE, MD

    MidAmerica Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vernon D. Rowe III, MD

Study Record Dates

First Submitted

May 15, 2002

First Posted

May 17, 2002

Study Start

July 1, 2001

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

April 12, 2018

Record last verified: 2018-04