NCT00086671

Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)

A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis With a 24-Week Double-Blind, Active Extension Phase

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of the trial is to study the safety and effectiveness of ABT-874 administered weekly or every other week in patients with relapsing remitting and secondary progressive multiple sclerosis as compared to placebo. Effectiveness will be measured based on MRI scans done periodically throughout the study.

Detailed description

This study was done in subjects with relapsing remitting MS or secondary progressive MS with the objective of assessing the safety and efficacy of 200 mg of ABT-874 weekly or QOW versus placebo. There were 3 phases to the study, 24 week double blind followed by 24 weeks of an active extension, followed by 48 weeks of double blind active extension. The trial was discontinued by Abbott in Aug 2006.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ABT-874/Human monoclonal antibody against IL-12
DRUG	Placebo

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2004-07-09
• Last updated: 2013-01-04

Locations

44 sites across 5 countries: United States, Canada, Germany, Netherlands, United Kingdom