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

18 mars 2015 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

56

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • Queensland
      • Cairns, Queensland, Australien
        • Local Institution
    • Victoria
      • Clayton, Victoria, Australien
        • Local Institution
      • Malvern, Victoria, Australien
        • Local Institution
    • Western Australia
      • Shenton Park, Western Australia, Australien
        • Local Institution
  • Belgien
      • Bruxelles, Belgien
        • Local Institution
      • Leuven, Belgien
        • Local Institution
  • Frankrike
      • Paris, Frankrike
        • Local Institution
      • Strasbourg Cedex, Frankrike
        • Local Institution
  • Förenta staterna
    • Alabama
      • Huntsville, Alabama, Förenta staterna
        • Local Institution
      • Mobile, Alabama, Förenta staterna
        • Local Institution
    • California
      • Huntington Beach, California, Förenta staterna
        • Local Institution
      • Los Angeles, California, Förenta staterna
        • Local Institution
    • Colorado
      • Boulder, Colorado, Förenta staterna
        • Local Institution
      • Colorado Springs, Colorado, Förenta staterna
        • Local Institution
    • Florida
      • Ft. Lauderdale, Florida, Förenta staterna
        • Local Institution
    • Illinois
      • Chicago, Illinois, Förenta staterna
        • Local Institution
    • Indiana
      • Evansville, Indiana, Förenta staterna
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna
        • Local Institution
    • Maryland
      • Cumberland, Maryland, Förenta staterna
        • Local Institution
      • Hagerstown, Maryland, Förenta staterna
        • Local Institution
    • Minnesota
      • Duluth, Minnesota, Förenta staterna
        • Local Institution
    • North Carolina
      • Durham, North Carolina, Förenta staterna
        • Local Institution
      • Wilmington, North Carolina, Förenta staterna
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna
        • Local Institution
    • Pennsylvania
      • Willow Grove, Pennsylvania, Förenta staterna
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, Förenta staterna
        • Local Institution
    • Texas
      • Austin, Texas, Förenta staterna
        • Local Institution
    • Virginia
      • Arlington, Virginia, Förenta staterna
        • Local Institution
  • Italien
      • Bari, Italien
        • Local Institution
      • Ferrara, Italien
        • Local Institution
      • Milano, Italien
        • Local Institution
  • Mexiko
    • Distrito Federal
      • Guadalajara, Distrito Federal, Mexiko
        • Local Institution
    • Guanajuato
      • Leon, Guanajuato, Mexiko
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexiko
        • Local Institution
    • Michioacan
      • Morelia, Michioacan, Mexiko
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico
        • Local Institution
  • Spanien
      • A Coruna, Spanien
        • Local Institution
      • Barcelona, Spanien
        • Local Institution
      • Madrid, Spanien
        • Local Institution
      • Oviedo, Spanien
        • Local Institution
      • Sevilla, Spanien
        • Local Institution
  • Storbritannien
    • Merseyside
      • Liverpool, Merseyside, Storbritannien
        • Local Institution
    • North Yorkshire
      • Leeds, North Yorkshire, Storbritannien
        • Local Institution
  • Tyskland
      • Berlin, Tyskland
        • Local Institution
      • Dresden, Tyskland
        • Local Institution
      • Hamburg, Tyskland
        • Local Institution
      • Hannover, Tyskland
        • Local Institution
      • Heidelberg, Tyskland
        • Local Institution

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: 2
Läkemedel: placebo
solution, intravenous injection, 0 mg, monthly, 169 days
Aktiv komparator: 1
Läkemedel: Abatacept

solution, intravenous injection, monthly, 169 days

weight based:

<60 kg = 500 mg

60 to 100 kg = 750 mg

>100 kg = 1 g

Andra namn:
  • Orencia

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2005

Primärt slutförande (Faktisk)

1 maj 2007

Avslutad studie (Faktisk)

1 april 2008

Studieregistreringsdatum

Först inskickad

30 juni 2005

Först inskickad som uppfyllde QC-kriterierna

27 juli 2005

Första postat (Uppskatta)

28 juli 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

7 april 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 mars 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IM101-046

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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