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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00086671
Recruitment Status : Completed
First Posted : July 9, 2004
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: ABT-874/Human monoclonal antibody against IL-12 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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
Study Start Date : April 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-874 200 mg weekly Drug: ABT-874/Human monoclonal antibody against IL-12
Placebo Comparator: Placebo Drug: Placebo
Experimental: ABT 874 QOW Drug: ABT-874/Human monoclonal antibody against IL-12



Primary Outcome Measures :
  1. Comparison of the cumulative number of Gd enhanced (T1 weighted) lesions during the treatment phase [ Time Frame: 24 weeks ]
  2. Safety and clinical laboratory parameters [ Time Frame: monthly ]
  3. vital signs [ Time Frame: monthly ]

Secondary Outcome Measures :
  1. Magnetic Resonance Imaging endpoints [ Time Frame: Screening ]
  2. Magnetic Resonance Imaging endpoints [ Time Frame: Baseline (Week 0) ]
  3. Magnetic Resonance Imaging endpoints [ Time Frame: Every 4 weeks after baseline through Week 24 ]
  4. Magnetic Resonance Imaging endpoints [ Time Frame: Every 12 weeks from Week 26 to Week 120 ]
  5. Magnetic Resonance Imaging endpoints [ Time Frame: Early Termination ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Any of the following risk factors for development of malignancy:

    • History of lymphoma or leukemia
    • Cutaneous squamous-cell or basal cell carcinoma (EXCEPT if treated more that two years prior to Screening with evidence of recurrence or residual disease)
    • Other malignancy (EXCEPT if treated more than five years prior to Screening without evidence of recurrence or residual disease) or
    • Disease associated with an increased risk of malignancy (such as familial polyposis).
  • History of major immunologic reaction (such as serum sickness or anaphylactoid reaction) to an Immunoglobulin G (IgG) containing agent (such as intravenous (IV) gamma globulin, a fusion protein, or monoclonal antibody)
  • Confounders of the assessment of neurologic response including other diseases that produce chronic neurologic manifestations (such as amyotrophic lateral sclerosis, Guillain-Barre syndrome, Lyme disease, myasthenia gravis, etc.)
  • Prior exposure to anti-IL-12 antibodies
  • Confounders of safety assessment, such as an unstable medical condition not related to MS (including those requiring an adjustment of treatment in the four weeks prior to Screening)
  • Exacerbation of asthma requiring hospitalization in the ten years prior to Screening (subjects with asthma not requiring hospitalization should be discussed with the medical monitor prior to Screening)
  • Pregnant or lactating females
  • The following exclusionary laboratory values at screening or baseline:

    • Hemoglobin (Hgb) <10 g/dL in females or <12 g/dL in males;
    • White blood cell (WBC) count <3 x 109/L;
    • Platelet count <100 x 109/L
    • Serum aspartate transaminase (AST) or alanine transaminase (ALT) x 3 upper limits of normal (ULN);
    • Serum total bilirubin >/= 3 mg/dL (>/= 51 x mol/L)
    • Serum creatinine >1.6 mg/dL (> 141 x mol/L)
  • Subject has a recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol
  • In the eight weeks prior to study drug administration, the subject has received a transfusion of any blood product, or has had 500 mL or more of blood removed by repetitive or one-time blood donation, plasmapheresis, or plasma exchange, or has lost 550 mL or more blood because of hemorrhage; or
  • For any reason, subject is considered by the investigator to be an unsuitable candidate to receive ABT-874.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086671


  Hide Study Locations
Locations
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United States, Arizona
Site Reference ID/Investigator# 107
Phoenix, Arizona, United States, 85013
Site Reference ID/Investigator# 163
Sun City, Arizona, United States, 85351
United States, Arkansas
Site Reference ID/Investigator# 156
Little Rock, Arkansas, United States, 72205
United States, California
Site Reference ID/Investigator# 154
Irvine, California, United States, 92618
Site Reference ID/Investigator# 161
Laguna Hills, California, United States, 92653
Site Reference ID/Investigator# 84
Sacramento, California, United States, 95817
United States, Colorado
Site Reference ID/Investigator# 119
Boulder, Colorado, United States, 80304
United States, Florida
Site Reference ID/Investigator# 111
Miami, Florida, United States, 33136
Site Reference ID/Investigator# 151
Tallahassee, Florida, United States, 32308
United States, Georgia
Site Reference ID/Investigator# 108
Atlanta, Georgia, United States, 30309
Site Reference ID/Investigator# 109
Atlanta, Georgia, United States, 30327
United States, Illinois
Site Reference ID/Investigator# 105
Northbrook, Illinois, United States, 60062
United States, Indiana
Site Reference ID/Investigator# 152
Indianapolis, Indiana, United States, 46260
United States, Kansas
Site Reference ID/Investigator# 258
Lenexa, Kansas, United States, 66214
United States, Kentucky
Site Reference ID/Investigator# 261
Lexington, Kentucky, United States, 40503
United States, Michigan
Site Reference ID/Investigator# 116
Detroit, Michigan, United States, 48201
Site Reference ID/Investigator# 158
Traverse City, Michigan, United States, 49684
United States, Missouri
Site Reference ID/Investigator# 124
St. Louis, Missouri, United States, 63110
United States, Nevada
Site Reference ID/Investigator# 259
Henderson, Nevada, United States, 89052
United States, New Hampshire
Site Reference ID/Investigator# 153
Lebanon, New Hampshire, United States, 03766
United States, New York
Site Reference ID/Investigator# 110
Albany, New York, United States, 12205
United States, North Carolina
Site Reference ID/Investigator# 117
Charlotte, North Carolina, United States, 28207
United States, Ohio
Site Reference ID/Investigator# 113
Columbus, Ohio, United States, 43210
Site Reference ID/Investigator# 157
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Site Reference ID/Investigator# 114
Allentown, Pennsylvania, United States, 18103
United States, Texas
Site Reference ID/Investigator# 128
Houston, Texas, United States, 77030
United States, Vermont
Site Reference ID/Investigator# 155
Bennington, Vermont, United States, 05201
Canada
Site Reference ID/Investigator# 132
Greenfield Park, Canada, J4V 2H1
Site Reference ID/Investigator# 130
Halifax, Canada, B3H 3A7
Site Reference ID/Investigator# 82
Ottawa, Canada, K1H 8L6
Site Reference ID/Investigator# 169
Sherbrooke, Canada, J1H 5N4
Site Reference ID/Investigator# 134
Vancouver, Canada, V6T 2B5
Germany
Site Reference ID/Investigator# 149
Frankfurt, Germany, 60528
Netherlands
Site Reference ID/Investigator# 137
Breda, Netherlands, 4818 CK
Site Reference ID/Investigator# 148
Nieuwegein, Netherlands, 3435 CM
Site Reference ID/Investigator# 138
Nijmwegen, Netherlands, 6533 PA
Site Reference ID/Investigator# 139
Sittard, Netherlands, 6131 BK
United Kingdom
Site Reference ID/Investigator# 159
Liverpool, United Kingdom, L97LJ
Site Reference ID/Investigator# 140
London, United Kingdom, SE1 1UL
Site Reference ID/Investigator# 142
Newcastle upon Tyne, United Kingdom, NE1 4LP
Site Reference ID/Investigator# 141
Nottingham, United Kingdom, NG7 2UH
Site Reference ID/Investigator# 144
Oxford, United Kingdom, OX2 6HE
Site Reference ID/Investigator# 143
Stoke on Trent, United Kingdom, ST4 7LN
Site Reference ID/Investigator# 160
Whitechapel, United Kingdom, E1 1 BB
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Chair: Martin Kaul, MD AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00086671     History of Changes
Other Study ID Numbers: M03-654
First Posted: July 9, 2004    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs