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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00124449
Registration number
NCT00124449
Ethics application status
Date submitted
30/06/2005
Date registered
28/07/2005
Date last updated
7/04/2015
Titles & IDs
Public title
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
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Scientific 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
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Secondary ID [1]
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IM101-046
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - placebo
Active Comparator: 1 -
Placebo Comparator: 2 -
Treatment: Drugs: Abatacept
solution, intravenous injection, monthly, 169 days
weight based:
<60 kg = 500 mg
60 to 100 kg = 750 mg
>100 kg = 1 g
Treatment: Drugs: placebo
solution, intravenous injection, 0 mg, monthly, 169 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy
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Assessment method [1]
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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.
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease
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Assessment method [2]
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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.
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Timepoint [2]
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12 months, 24 months
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Secondary outcome [3]
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Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, 6 months, 12 months, 24 months
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Secondary outcome [4]
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Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, 6 months, 12 months, 24 months
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Secondary outcome [5]
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Number of Participants With Persistent Symptomatic Clinical Synovitis
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Assessment method [5]
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Synovitis, assessed by clinical signs and symptoms
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Timepoint [5]
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6, 12, and 24 months
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Secondary outcome [6]
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Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline
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Assessment method [6]
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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.
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Timepoint [6]
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6 months, 12 months, 24 months
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Secondary outcome [7]
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Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, 6 Months, 12 months, 24 months
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Secondary outcome [8]
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Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time
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Assessment method [8]
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To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive
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Timepoint [8]
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Day 1, 6 months, 12 months, 24 months
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Secondary outcome [9]
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Frequency of Human Leukocyte Antigen (HLA) Typing
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Assessment method [9]
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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).
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Timepoint [9]
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Day 1
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Secondary outcome [10]
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DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline
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Assessment method [10]
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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.
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Timepoint [10]
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6 months, 12 months, 24 months
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Secondary outcome [11]
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Number of Participants With a DAS 28 (CRP) Score of =3.2 (Low Disease Activity) or <2.6 (in Remission)
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Assessment method [11]
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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).
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Timepoint [11]
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6 months, 12 months, 24 months
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Secondary outcome [12]
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Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response
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Assessment method [12]
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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.
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Timepoint [12]
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6 months, 12 months, 24 months
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Secondary outcome [13]
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Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths
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Assessment method [13]
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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
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Timepoint [13]
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Throughout the treatment period (6 months)
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Secondary outcome [14]
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Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies
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Assessment method [14]
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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.
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Timepoint [14]
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Up to 12 months
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2008
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Sample size
Target
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Accrual to date
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Final
56
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - Cairns
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Recruitment hospital [2]
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Local Institution - Clayton
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Recruitment hospital [3]
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Local Institution - Malvern
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Recruitment hospital [4]
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Local Institution - Shenton Park
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Recruitment postcode(s) [1]
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- Cairns
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Recruitment postcode(s) [2]
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- Clayton
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Recruitment postcode(s) [3]
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- Malvern
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Recruitment postcode(s) [4]
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- Shenton Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Louisiana
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United States of America
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Maryland
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Minnesota
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North Carolina
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Oklahoma
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Belgium
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Bruxelles
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Belgium
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Leuven
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France
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Paris
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France
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Strasbourg Cedex
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Italy
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Bari
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Italy
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Ferrara
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Italy
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Milano
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Michioacan
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Puerto Rico
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Ponce
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Spain
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A Coruna
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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Sevilla
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United Kingdom
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Merseyside
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United Kingdom
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State/province [39]
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North Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00124449
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Trial related presentations / publications
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. Erratum In: Ann Rheum Dis. 2011 Aug;70(8):1519.
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00124449
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