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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:  NCT00122382
Date of registration: 19/07/2005
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Remission and Joint Damage Progression in Early Rheumatoid Arthritis
Scientific title: A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate
Date of first enrolment: July 2005
Target sample size: 1052
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00122382
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Australia Austria Belgium Brazil Canada Czech Republic France Germany
Ireland Italy Korea, Republic of Mexico Netherlands Poland Puerto Rico Russian Federation
South Africa 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 rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3
weeks. No dose within 3 months prior to informed consent.

- C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)

- Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive

- Tender joints >=12 and swollen joints >=10

Exclusion Criteria:

- Women and men who are not willing to use birth control

- Diagnosed with other rheumatic disease

- History of cancer within 5 years

- Active tuberculosis

- Treatment with another investigation drug within 28 days

- Active bacterial or viral infection



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: methotrexate
Drug: placebo
Primary Outcome(s)
Incidence Rates of Autoimmune Disorders in ABA-Treated Participants [Time Frame: Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).]
Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants [Time Frame: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).]
Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants [Time Frame: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).]
Mean Change From Baseline in Radiographic Total Score to Month 12 [Time Frame: Baseline, Month 12]
Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12 [Time Frame: Month 12]
Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period [Time Frame: Open-Label Period (Month 12 to Month 24)]
Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period [Time Frame: Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.]
Number of Participants With SAEs With an Outcome of Death During the Open-label Period [Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.]
Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period [Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.]
Number of Participants With Serious Adverse Events Reported During the Open-Label Period [Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.]
Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period [Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.]
Secondary Outcome(s)
Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12 [Time Frame: Baseline, Month 12]
Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12 [Time Frame: Baseline, Month 12]
Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12 [Time Frame: Baseline, Month 12]
Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24 [Time Frame: Baseline, Month 24]
Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score) [Time Frame: Baseline, Month 12, Month 24]
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period [Time Frame: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.]
Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12 [Time Frame: Month 12]
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA [Time Frame: Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.]
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA) [Time Frame: includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.]
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12 [Time Frame: Month 12]
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24 [Time Frame: Baseline, Month 24]
Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period [Time Frame: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.]
Number of Participants With Major Clinical Response (MCR) at Month 12 [Time Frame: Month 12]
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12 [Time Frame: Month 12, Month 24]
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24 [Time Frame: Baseline, Month 24]
Secondary ID(s)
IM101-023
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 13/07/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00122382
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