NCT00859482

Brief Summary

Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene 4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also with central nervous system (CNS) immune surveillance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Shorter than P25 for all trials

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, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
Last Updated

March 11, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

March 10, 2009

Last Update Submit

March 10, 2009

Conditions

Multiple Sclerosis, Relapsing Remitting

Keywords

natalizumabmultiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • Function of T regulatory cells

    at month 3

Secondary Outcomes (1)

  • Change in distinct immune cell lines

    month 3

Eligibility Criteria

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

Patients initiating natalizumab for treatment of relapsing remitting MS

You may qualify if:

  • relapsing remitting MS
  • indication for natalizumab treatment

You may not qualify if:

  • other disease modifying agents within 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

full blodd

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Norman Putzki, MD

    KSSG, 9007 St. Gallen, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

July 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 11, 2009

Record last verified: 2009-03