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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00124449
Date of registration: 30/06/2005
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
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
Date of first enrolment: February 2005
Target sample size: 56
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00124449
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Australia Belgium France Germany Italy Mexico Puerto Rico Spain
United Kingdom United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Drug: Abatacept
Drug: placebo
Primary Outcome(s)
Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy [Time Frame: 12 months]
Secondary Outcome(s)
Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months [Time Frame: Baseline, 6 Months, 12 months, 24 months]
Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months [Time Frame: Baseline, 6 months, 12 months, 24 months]
Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months [Time Frame: Baseline, 6 months, 12 months, 24 months]
DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline [Time Frame: 6 months, 12 months, 24 months]
Frequency of Human Leukocyte Antigen (HLA) Typing [Time Frame: Day 1]
Number of Participants With a DAS 28 (CRP) Score of =3.2 (Low Disease Activity) or <2.6 (in Remission) [Time Frame: 6 months, 12 months, 24 months]
Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy [Time Frame: 24 months]
Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time [Time Frame: Day 1, 6 months, 12 months, 24 months]
Number of Participants With Persistent Symptomatic Clinical Synovitis [Time Frame: 6, 12, and 24 months]
Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies [Time Frame: Up to 12 months]
Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease [Time Frame: 12 months, 24 months]
Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response [Time Frame: 6 months, 12 months, 24 months]
Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths [Time Frame: Throughout the treatment period (6 months)]
Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline [Time Frame: 6 months, 12 months, 24 months]
Secondary ID(s)
IM101-046
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/11/2009
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00124449
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