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

NCT00086671 | Completed Phase 2 DMC

• 1 other identifier: M03-654
• Study Type: interventional
• Target: 215
• Locations: 5 countries
• Sites: 44

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Comparison of the cumulative number of Gd enhanced (T1 weighted) lesions during the treatment phase

  24 weeks

• Safety and clinical laboratory parameters

  monthly

• vital signs

  monthly

Secondary Outcomes (5)

• Magnetic Resonance Imaging endpoints

  Screening

• Magnetic Resonance Imaging endpoints

  Baseline (Week 0)

• Magnetic Resonance Imaging endpoints

  Every 4 weeks after baseline through Week 24

• Magnetic Resonance Imaging endpoints

  Every 12 weeks from Week 26 to Week 120

• Magnetic Resonance Imaging endpoints

  Early Termination

Study Arms (3)

ABT-874 200 mg weekly

EXPERIMENTAL

Drug: ABT-874/Human monoclonal antibody against IL-12

Placebo

PLACEBO COMPARATOR

Drug: Placebo

ABT 874 QOW

EXPERIMENTAL

Drug: ABT-874/Human monoclonal antibody against IL-12

Interventions

ABT-874/Human monoclonal antibody against IL-12 DRUG

ABT 874 QOW; ABT-874 200 mg weekly

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 55 years
• Diagnosis of active relapse within 12 months of screening.
• 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

You may not qualify if:

• Primary progressive multiple sclerosis (PPMS)
• Immunosuppressive therapy (such as azathioprine, methotrexate (MTX), but excluding corticosteroids) within six months of randomization. Subjects with previous treatment with cyclophosphamide, total lymphoid irradiation, mitoxantrone, cladribine, or bone marrow transplantation, regardless of duration, will be excluded from participation in this study
• Systemic corticosteroid therapy within four weeks prior to the first screening Magnetic Resonance Imaging (MRI)
• Participation in any clinical study, whether or not it involves an investigational drug within three months prior to the screening visit
• Use of any investigational drug with disease-modifying potential for the treatment of multiple sclerosis (MS) within six months of randomization (prior use of investigational agents for the symptomatic treatment of MS, e.g., 4-aminopyridine (4-AP), may be allowed following discussion with medical monitor
• Concomitant statin use in doses exceeding the manufacturers' maximum recommended daily dosages for treatment of hypercholesterolemia or as part of an MS disease-modifying protocol
• Infection or risk factors for severe infections
• Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus (HIV) infection
• Severe, recurrent, or persistent infections \[such as Hepatitis B or C, or borreliosis or recurrent urinary tract infection (UTI) (\> 3 UTIs requiring antibiotic treatment per year) or recurrent pneumonia (\> 2 pneumonias requiring antibiotic treatment per year) or infected decubitus ulcers\]
• Evidence of current inactive tuberculosis (TB) infection; recent exposure to mycobacterium tuberculosis (converters to a positive purified protein derivative \[PPD\]). Subjects with a positive PPD or a chest X-ray suggestive of prior TB infection will be excluded
• Active tuberculosis disease
• Active chronic Lyme disease
• Active syphilis
• Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Screening; or
• Infection requiring treatment with antibiotics in the two weeks prior to Screening.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (44)

Site Reference ID/Investigator# 107

Phoenix, Arizona, 85013, United States

Location

Site Reference ID/Investigator# 163

Sun City, Arizona, 85351, United States

Location

Site Reference ID/Investigator# 156

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 154

Irvine, California, 92618, United States

Location

Site Reference ID/Investigator# 161

Laguna Hills, California, 92653, United States

Location

Site Reference ID/Investigator# 84

Sacramento, California, 95817, United States

Location

Site Reference ID/Investigator# 119

Boulder, Colorado, 80304, United States

Location

Site Reference ID/Investigator# 111

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 151

Tallahassee, Florida, 32308, United States

Location

Site Reference ID/Investigator# 108

Atlanta, Georgia, 30309, United States

Location

Site Reference ID/Investigator# 109

Atlanta, Georgia, 30327, United States

Location

Site Reference ID/Investigator# 105

Northbrook, Illinois, 60062, United States

Location

Site Reference ID/Investigator# 152

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 258

Lenexa, Kansas, 66214, United States

Location

Site Reference ID/Investigator# 261

Lexington, Kentucky, 40503, United States

Location

Site Reference ID/Investigator# 116

Detroit, Michigan, 48201, United States

Location

Site Reference ID/Investigator# 158

Traverse City, Michigan, 49684, United States

Location

Site Reference ID/Investigator# 124

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 259

Henderson, Nevada, 89052, United States

Location

Site Reference ID/Investigator# 153

Lebanon, New Hampshire, 03766, United States

Location

Site Reference ID/Investigator# 110

Albany, New York, 12205, United States

Location

Site Reference ID/Investigator# 117

Charlotte, North Carolina, 28207, United States

Location

Site Reference ID/Investigator# 113

Columbus, Ohio, 43210, United States

Location

Site Reference ID/Investigator# 157

Dayton, Ohio, 45409, United States

Location

Site Reference ID/Investigator# 114

Allentown, Pennsylvania, 18103, United States

Location

Site Reference ID/Investigator# 128

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 155

Bennington, Vermont, 05201, United States

Location

Site Reference ID/Investigator# 132

Greenfield Park, J4V 2H1, Canada

Location

Site Reference ID/Investigator# 130

Halifax, B3H 3A7, Canada

Location

Site Reference ID/Investigator# 82

Ottawa, K1H 8L6, Canada

Location

Site Reference ID/Investigator# 169

Sherbrooke, J1H 5N4, Canada

Location

Site Reference ID/Investigator# 134

Vancouver, V6T 2B5, Canada

Location

Site Reference ID/Investigator# 149

Frankfurt, 60528, Germany

Location

Site Reference ID/Investigator# 137

Breda, 4818 CK, Netherlands

Location

Site Reference ID/Investigator# 148

Nieuwegein, 3435 CM, Netherlands

Location

Site Reference ID/Investigator# 138

Nijmwegen, 6533 PA, Netherlands

Location

Site Reference ID/Investigator# 139

Sittard, 6131 BK, Netherlands

Location

Site Reference ID/Investigator# 159

Liverpool, L97LJ, United Kingdom

Location

Site Reference ID/Investigator# 140

London, SE1 1UL, United Kingdom

Location

Site Reference ID/Investigator# 142

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Site Reference ID/Investigator# 141

Nottingham, NG7 2UH, United Kingdom

Location

Site Reference ID/Investigator# 144

Oxford, OX2 6HE, United Kingdom

Location

Site Reference ID/Investigator# 143

Stoke-on-Trent, ST4 7LN, United Kingdom

Location

Site Reference ID/Investigator# 160

Whitechapel, E1 1 BB, United Kingdom

Location

Related Publications (1)

• Vollmer TL, Wynn DR, Alam MS, Valdes J. A phase 2, 24-week, randomized, placebo-controlled, double-blind study examining the efficacy and safety of an anti-interleukin-12 and -23 monoclonal antibody in patients with relapsing-remitting or secondary progressive multiple sclerosis. Mult Scler. 2011 Feb;17(2):181-91. doi: 10.1177/1352458510384496. Epub 2010 Dec 6.

  PMID: 21135022 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Martin Kaul, MD

  AbbVie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2004
• First Posted: July 9, 2004
• Study Start: April 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

DE (1); US (27); CA (5); NL (4); GB (7)