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Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

18 mars 2015 mis à jour par: Bristol-Myers Squibb

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

56

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne
        • Local Institution
      • Dresden, Allemagne
        • Local Institution
      • Hamburg, Allemagne
        • Local Institution
      • Hannover, Allemagne
        • Local Institution
      • Heidelberg, Allemagne
        • Local Institution
  • Australie
    • Queensland
      • Cairns, Queensland, Australie
        • Local Institution
    • Victoria
      • Clayton, Victoria, Australie
        • Local Institution
      • Malvern, Victoria, Australie
        • Local Institution
    • Western Australia
      • Shenton Park, Western Australia, Australie
        • Local Institution
  • Belgique
      • Bruxelles, Belgique
        • Local Institution
      • Leuven, Belgique
        • Local Institution
  • Espagne
      • A Coruna, Espagne
        • Local Institution
      • Barcelona, Espagne
        • Local Institution
      • Madrid, Espagne
        • Local Institution
      • Oviedo, Espagne
        • Local Institution
      • Sevilla, Espagne
        • Local Institution
  • France
      • Paris, France
        • Local Institution
      • Strasbourg Cedex, France
        • Local Institution
  • Italie
      • Bari, Italie
        • Local Institution
      • Ferrara, Italie
        • Local Institution
      • Milano, Italie
        • Local Institution
  • Mexique
    • Distrito Federal
      • Guadalajara, Distrito Federal, Mexique
        • Local Institution
    • Guanajuato
      • Leon, Guanajuato, Mexique
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexique
        • Local Institution
    • Michioacan
      • Morelia, Michioacan, Mexique
        • Local Institution
  • Porto Rico
      • Ponce, Porto Rico
        • Local Institution
  • Royaume-Uni
    • Merseyside
      • Liverpool, Merseyside, Royaume-Uni
        • Local Institution
    • North Yorkshire
      • Leeds, North Yorkshire, Royaume-Uni
        • Local Institution
  • États-Unis
    • Alabama
      • Huntsville, Alabama, États-Unis
        • Local Institution
      • Mobile, Alabama, États-Unis
        • Local Institution
    • California
      • Huntington Beach, California, États-Unis
        • Local Institution
      • Los Angeles, California, États-Unis
        • Local Institution
    • Colorado
      • Boulder, Colorado, États-Unis
        • Local Institution
      • Colorado Springs, Colorado, États-Unis
        • Local Institution
    • Florida
      • Ft. Lauderdale, Florida, États-Unis
        • Local Institution
    • Illinois
      • Chicago, Illinois, États-Unis
        • Local Institution
    • Indiana
      • Evansville, Indiana, États-Unis
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, États-Unis
        • Local Institution
    • Maryland
      • Cumberland, Maryland, États-Unis
        • Local Institution
      • Hagerstown, Maryland, États-Unis
        • Local Institution
    • Minnesota
      • Duluth, Minnesota, États-Unis
        • Local Institution
    • North Carolina
      • Durham, North Carolina, États-Unis
        • Local Institution
      • Wilmington, North Carolina, États-Unis
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis
        • Local Institution
    • Pennsylvania
      • Willow Grove, Pennsylvania, États-Unis
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, États-Unis
        • Local Institution
    • Texas
      • Austin, Texas, États-Unis
        • Local Institution
    • Virginia
      • Arlington, Virginia, États-Unis
        • Local Institution

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Diagnosis of undifferentiated arthritis
  • Clinical synovitis of two or more joints
  • At least one but not more than three of the criteria for diagnosis of RA (1987).
  • No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
  • Duration of disease must be 18 months or less.
  • Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria:

  • Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
  • Active vasculitis of a major organ system.
  • Severe or recurrent bacterial infection.
  • History of cancer in the last five years except certain skin cancers.
  • Herpes zoster that resolved less than 2 months prior to enrollment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 2
Médicament: placebo
solution, intravenous injection, 0 mg, monthly, 169 days
Comparateur actif: 1
Médicament: Abatacept

solution, intravenous injection, monthly, 169 days

weight based:

<60 kg = 500 mg

60 to 100 kg = 750 mg

>100 kg = 1 g

Autres noms:
  • Orencia

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
Délai: 12 months
ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy
Délai: 24 months
ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
24 months
Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease
Délai: 12 months, 24 months
Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
12 months, 24 months
Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months
Délai: Baseline, 6 months, 12 months, 24 months
Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.
Baseline, 6 months, 12 months, 24 months
Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months
Délai: Baseline, 6 months, 12 months, 24 months
Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.
Baseline, 6 months, 12 months, 24 months
Number of Participants With Persistent Symptomatic Clinical Synovitis
Délai: 6, 12, and 24 months
Synovitis, assessed by clinical signs and symptoms
6, 12, and 24 months
Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline
Délai: 6 months, 12 months, 24 months
SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.
6 months, 12 months, 24 months
Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months
Délai: Baseline, 6 Months, 12 months, 24 months
To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], tumor necrosis factor Alpha [TNF-Alpha], Matrix Metalloproteinase 3T [MMP3T], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.
Baseline, 6 Months, 12 months, 24 months
Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time
Délai: Day 1, 6 months, 12 months, 24 months
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive
Day 1, 6 months, 12 months, 24 months
Frequency of Human Leukocyte Antigen (HLA) Typing
Délai: Day 1
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).
Day 1
DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline
Délai: 6 months, 12 months, 24 months
The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.
6 months, 12 months, 24 months
Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)
Délai: 6 months, 12 months, 24 months
The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (< 2.6).
6 months, 12 months, 24 months
Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response
Délai: 6 months, 12 months, 24 months
This questionnaire includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. Higher scores indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.
6 months, 12 months, 24 months
Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths
Délai: Throughout the treatment period (6 months)
AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely
Throughout the treatment period (6 months)
Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies
Délai: Up to 12 months
Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of > 400 and for tip assessment was ≥25.
Up to 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bristol-Myers Squibb

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2005

Achèvement primaire (Réel)

1 mai 2007

Achèvement de l'étude (Réel)

1 avril 2008

Dates d'inscription aux études

Première soumission

30 juin 2005

Première soumission répondant aux critères de contrôle qualité

27 juillet 2005

Première publication (Estimation)

28 juillet 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

7 avril 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mars 2015

Dernière vérification

1 mars 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IM101-046

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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