NCT00097331

Brief Summary

The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis (MS), using data from magnetic resonance imaging (MRI) scans as the main measure.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Geographic Reach
5 countries

11 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

September 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

November 22, 2004

Last Update Submit

April 10, 2015

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

multiple sclerosisrelapsingremittingRelapsing-Remitting MS (RRMS)

Outcome Measures

Primary Outcomes (1)

  • Number of new gadolinium-enhancing lesions on monthly MRI scans

Secondary Outcomes (5)

  • Number of other lesion types on MRI

  • Number of relapses during treatment

  • Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)

  • Circulating lymphocyte and neutrophil counts

  • Health Outcomes: MSIS-29, Employment status

Interventions

SB683699DRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of multiple sclerosis (MS).
  • Expanded Disability Status Score 0 - 6.5.
  • One or more relapse of MS in previous 12 months.
  • Currently not taking any medications for MS (apart from those used to treat symptoms).

You may not qualify if:

  • Patients with significantly abnormal laboratory tests or electrocardiogram (ECG) results.
  • Subjects who cannot have MRI scans.
  • Women who are pregnant, breast feeding or planning to become pregnant during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Fraiture En Condroz, 4557, Belgium

Location

GSK Investigational Site

Hamburg, Hamburg, 20099, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 22087, Germany

Location

GSK Investigational Site

Polanki, 80-308, Poland

Location

GSK Investigational Site

Poznan, 60-479, Poland

Location

GSK Investigational Site

Warsaw, 02-957, Poland

Location

GSK Investigational Site

Moscow, 117049, Russia

Location

GSK Investigational Site

Moscow, 125367, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisRecurrence

Interventions

Firategrast

Condition Hierarchy (Ancestors)

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

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2004

First Posted

November 23, 2004

Study Start

September 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

RU(3)ES(1)BE(2)DE(2)PL(3)