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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00086671

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive	Drug: ABT-874/Human monoclonal antibody against IL-12	Phase II

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Immunoglobulins Globulin, Immune Interleukin-12

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Abbott:

Primary Outcome Measures:

Comparison of the cumulative number of Gd enhanced (T1 weighted) lesions during the 24 week treatment phase. [ Time Frame: 24 week ]

Secondary Outcome Measures:

MRI endpoints
Safety and clinical laboratory parameters
Vital signs

Enrollment:	215
Study Start Date:	May 2004
Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18-55 years
Diagnosis of active relapsing remitting or secondary progressive multiple sclerosis
At least one relapse within 12 months of screening.
Must be able to walk at least 65 feet with or without assistance
Off Copaxone or interferon therapy for two months prior to screening
Able and willing to learn to self administer weekly injections, or have a designee who will administer study medication
Female participants must use contraceptives while on study drug

Exclusion Criteria:

Patients with the following conditions are not eligible to participate in the study:

Primary progressive multiple sclerosis
Active TB, HIV, Lyme disease, syphilis, Hepatitis B or C, or other active infections
Pregnant or lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086671

Show 42 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Beverly Paperiello

Abbott

More Information

Study ID Numbers:	M03-654
Study First Received:	July 7, 2004
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00086671
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Interleukin-12
Demyelinating Diseases
Sclerosis
Demyelinating diseases
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Antibodies, Monoclonal

Signs and Symptoms
Antibodies
Multiple Sclerosis
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases

Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009