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Multiple SclerosisPhase 2NCT00086671

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

A Phase 2 study testing ABT-874/Human monoclonal antibody against IL-12 in people with Multiple Sclerosis, run by AbbVie (prior sponsor, Abbott) at 44 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
ABT-874/Human monoclonal antibody against IL-12
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
215 participants
Where
44 sitesin 5 countries
Study dates
Apr 2004to Nov 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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.

Trial locations and contacts

44 sites in 5 countries.

44 sites in 5 countries

United States27 sites

  • Site Reference ID/Investigator# 110

    Albany, New York, 12205

  • Site Reference ID/Investigator# 114

    Allentown, Pennsylvania, 18103

  • Site Reference ID/Investigator# 108

    Atlanta, Georgia, 30309

  • Site Reference ID/Investigator# 109

    Atlanta, Georgia, 30327

  • Site Reference ID/Investigator# 155

    Bennington, Vermont, 05201

  • Site Reference ID/Investigator# 119

    Boulder, Colorado, 80304

  • Site Reference ID/Investigator# 117

    Charlotte, North Carolina, 28207

  • Site Reference ID/Investigator# 113

    Columbus, Ohio, 43210

  • Site Reference ID/Investigator# 157

    Dayton, Ohio, 45409

  • Site Reference ID/Investigator# 116

    Detroit, Michigan, 48201

  • Site Reference ID/Investigator# 259

    Henderson, Nevada, 89052

  • Site Reference ID/Investigator# 128

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 152

    Indianapolis, Indiana, 46260

  • Site Reference ID/Investigator# 154

    Irvine, California, 92618

  • Site Reference ID/Investigator# 161

    Laguna Hills, California, 92653

  • Site Reference ID/Investigator# 153

    Lebanon, New Hampshire, 03766

  • Site Reference ID/Investigator# 258

    Lenexa, Kansas, 66214

  • Site Reference ID/Investigator# 261

    Lexington, Kentucky, 40503

  • Site Reference ID/Investigator# 156

    Little Rock, Arkansas, 72205

  • Site Reference ID/Investigator# 111

    Miami, Florida, 33136

  • Site Reference ID/Investigator# 105

    Northbrook, Illinois, 60062

  • Site Reference ID/Investigator# 107

    Phoenix, Arizona, 85013

  • Site Reference ID/Investigator# 84

    Sacramento, California, 95817

  • Site Reference ID/Investigator# 124

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator# 163

    Sun City, Arizona, 85351

  • Site Reference ID/Investigator# 151

    Tallahassee, Florida, 32308

  • Site Reference ID/Investigator# 158

    Traverse City, Michigan, 49684

Other trials in United States

United Kingdom7 sites

  • Site Reference ID/Investigator# 159

    Liverpool, L97LJ

  • Site Reference ID/Investigator# 140

    London, SE1 1UL

  • Site Reference ID/Investigator# 142

    Newcastle upon Tyne, NE1 4LP

  • Site Reference ID/Investigator# 141

    Nottingham, NG7 2UH

  • Site Reference ID/Investigator# 144

    Oxford, OX2 6HE

  • Site Reference ID/Investigator# 143

    Stoke-on-Trent, ST4 7LN

  • Site Reference ID/Investigator# 160

    Whitechapel, E1 1 BB

Other trials in United Kingdom

Canada5 sites

  • Site Reference ID/Investigator# 132

    Greenfield Park, J4V 2H1

  • Site Reference ID/Investigator# 130

    Halifax, B3H 3A7

  • Site Reference ID/Investigator# 82

    Ottawa, K1H 8L6

  • Site Reference ID/Investigator# 169

    Sherbrooke, J1H 5N4

  • Site Reference ID/Investigator# 134

    Vancouver, V6T 2B5

Other trials in Canada

Netherlands4 sites

  • Site Reference ID/Investigator# 137

    Breda, 4818 CK

  • Site Reference ID/Investigator# 148

    Nieuwegein, 3435 CM

  • Site Reference ID/Investigator# 138

    Nijmwegen, 6533 PA

  • Site Reference ID/Investigator# 139

    Sittard, 6131 BK

Other trials in Netherlands

Germany1 site

  • Site Reference ID/Investigator# 149

    Frankfurt, 60528

Other trials in Germany

About this 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

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.

Read the 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.

Being tested
ABT-874/Human monoclonal antibody against IL-12, Placebo
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  • PlaceboDrug

Study groups in NCT00086671
Study groupRoleWhat they receive
ABT-874 200 mg weeklyExperimentalNot described
Receives: Drug: ABT-874/Human monoclonal antibody against IL-12
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
ABT 874 QOWExperimentalNot described
Receives: Drug: ABT-874/Human monoclonal antibody against IL-12

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 weeks

  2. Safety and clinical laboratory parameters

    Measured: monthly

  3. vital signs

    Measured: monthly

Secondary outcomes (5)

  1. Magnetic Resonance Imaging endpoints

    Measured: Screening

  2. Magnetic Resonance Imaging endpoints

    Measured: Baseline (Week 0)

  3. Magnetic Resonance Imaging endpoints

    Measured: Every 4 weeks after baseline through Week 24

  4. Magnetic Resonance Imaging endpoints

    Measured: Every 12 weeks from Week 26 to Week 120

  5. Magnetic Resonance Imaging endpoints

    Measured: Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionNov 2006
  4. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086671
Sponsor's protocol ID
M03-654
Status last verified
Jan 2013
First submitted
7 Jul 2004
Last updated
4 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21135022

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-874/Human monoclonal antibody against IL-12 in people with Multiple Sclerosis, run by AbbVie (prior sponsor, Abbott) at 44 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, United Kingdom, Canada, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the cumulative number of Gd enhanced (T1 weighted) lesions during the treatment phase (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00086671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.

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