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

2 gennaio 2013 aggiornato da: AbbVie (prior sponsor, Abbott)

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

215

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Sperimentale: ABT-874 200 mg weekly
Droga: ABT-874/Human monoclonal antibody against IL-12
Sperimentale: ABT 874 QOW
Droga: ABT-874/Human monoclonal antibody against IL-12

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Comparison of the cumulative number of Gd enhanced (T1 weighted) lesions during the treatment phase
Lasso di tempo: 24 weeks
24 weeks
Safety and clinical laboratory parameters
Lasso di tempo: monthly
monthly
vital signs
Lasso di tempo: monthly
monthly

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Magnetic Resonance Imaging endpoints
Lasso di tempo: Screening
Screening
Magnetic Resonance Imaging endpoints
Lasso di tempo: Baseline (Week 0)
Baseline (Week 0)
Magnetic Resonance Imaging endpoints
Lasso di tempo: Every 4 weeks after baseline through Week 24
Every 4 weeks after baseline through Week 24
Magnetic Resonance Imaging endpoints
Lasso di tempo: Every 12 weeks from Week 26 to Week 120
Every 12 weeks from Week 26 to Week 120
Magnetic Resonance Imaging endpoints
Lasso di tempo: Early Termination
Early Termination

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigatori

  • Cattedra di studio: Martin Kaul, MD, AbbVie

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2004

Completamento primario (Effettivo)

1 novembre 2006

Completamento dello studio (Effettivo)

1 novembre 2006

Date di iscrizione allo studio

Primo inviato

7 luglio 2004

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2004

Primo Inserito (Stima)

9 luglio 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 gennaio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 gennaio 2013

Ultimo verificato

1 gennaio 2013

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • M03-654

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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