Clinical trial NCT00124449: Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy
timeFrame: 24 months
measure: Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease
timeFrame: 12 months, 24 months
measure: Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Number of Participants With Persistent Symptomatic Clinical Synovitis
timeFrame: 6, 12, and 24 months
measure: Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline
timeFrame: 6 months, 12 months, 24 months
measure: Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months
timeFrame: Baseline, 6 Months, 12 months, 24 months
measure: Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time
timeFrame: Day 1, 6 months, 12 months, 24 months
measure: Frequency of Human Leukocyte Antigen (HLA) Typing
timeFrame: Day 1
measure: DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline
timeFrame: 6 months, 12 months, 24 months
measure: Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)
timeFrame: 6 months, 12 months, 24 months
measure: Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response
timeFrame: 6 months, 12 months, 24 months
measure: Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths
timeFrame: Throughout the treatment period (6 months)
measure: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Local Institution
state: Alabama
city: Mobile
country: United States
facility: Local Institution
state: Alabama
city: Huntington Beach
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Boulder
country: United States
facility: Local Institution
state: Colorado
city: Colorado Springs
country: United States
facility: Local Institution
state: Colorado
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Evansville
country: United States
facility: Local Institution
state: Indiana
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Cumberland
country: United States
facility: Local Institution
state: Maryland
city: Hagerstown
country: United States
facility: Local Institution
state: Maryland
city: Duluth
country: United States
facility: Local Institution
state: Minnesota
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Wilmington
country: United States
facility: Local Institution
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Willow Grove
country: United States
facility: Local Institution
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Arlington
country: United States
facility: Local Institution
state: Virginia
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Clayton
country: Australia
facility: Local Institution
state: Victoria
city: Malvern
country: Australia
facility: Local Institution
state: Victoria
city: Shenton Park
country: Australia
facility: Local Institution
state: Western Australia
city: Bruxelles
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Ferrara
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Leon
country: Mexico
facility: Local Institution
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution
state: Michioacan
city: Ponce
country: Puerto Rico
facility: Local Institution
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Oviedo
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Liverpool
country: United Kingdom
facility: Local Institution
state: Merseyside
city: Leeds
country: United Kingdom
facility: Local Institution
state: North Yorkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Emery P, Durez P, Dougados M, Legerton CW, Becker JC, Vratsanos G, Genant HK, Peterfy C, Mitra P, Overfield S, Qi K, Westhovens R. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016. Epub 2009 Nov 23.