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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:  NCT00095147
Date of registration: 01/11/2004
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Scientific title: A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate
Date of first enrolment: February 2005
Target sample size: 431
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00095147
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Argentina Australia Brazil Canada Czech Republic Denmark Korea, Republic of Mexico
Peru Poland Puerto Rico Russian Federation South Africa Spain Sweden Switzerland
United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of Rheumatoid Arthritis

- At least 3 months prior treatment with Methotrexate (MTX)

- At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1
mg/dl

- Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion Criteria:

- participants who have failed more than 3 DMARDs

- participants previously treated with an approved biologic drug

- History of cancer in the last 5 years

- Severe or recurrent bacterial infection

- Any previous or current medical conditions that are contraindications to the use of
TNF blocking agents

- Women of Child Bearing Potential



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: ABA, open-label (OL)
Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
Drug: Infliximab (INF) + MTX, DB
Drug: PLA + MTX switched to ABA+ MTX, DB
Drug: Placebo (PLA) + MTX, DB
Primary Outcome(s)
DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis) [Time Frame: Baseline (Day 1), 6 months (Day 197)]
OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1121 in Electrolytes [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1121 in Erythrocytes [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1121 in Hematocrit [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1121 in Platelets [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1121 in White Blood Cells [Time Frame: Baseline (Day 1), Day 1121]
OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 1513 in Electrolytes [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 1513 in Erythrocytes [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 1513 in Hematocrit [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 1513 in Platelets [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 1513 in White Blood Cells [Time Frame: Baseline (Day 1), Day 1513]
OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 365 in Electrolytes [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 365 in Erythrocytes [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 365 in Hematocrit [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 365 in Platelets [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 365 in White Blood Cells [Time Frame: Baseline (Day 1), Day 365]
OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Change From Baseline to Day 729 in Electrolytes [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Change From Baseline to Day 729 in Erythrocytes [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Change From Baseline to Day 729 in Hematocrit [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Change From Baseline to Day 729 in Platelets [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Change From Baseline to Day 729 in White Blood Cells [Time Frame: Baseline (Day 1), Day 729]
OL; Mean Heart Rate (HR) During Open Label Period [Time Frame: Days 365, 729, 1121, and 1513]
OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period [Time Frame: Days 365, 729, 1121, and 1513]
OL; Mean Temperature (T) During Open Label Period [Time Frame: Days 365, 729, 1121, and 1513]
OL; Number of Participants With AEs of Special Interest [Time Frame: From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)]
OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation [Time Frame: From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)]
OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities [Time Frame: From Day 366 through end of OL (range from 1.9 months to 42.3 months)]
OL; Number of Participants With Select Hematologic Laboratory Abnormalities [Time Frame: From Day 366 through end of OL (range from 1.9 months to 42.3 months)]
Secondary Outcome(s)
DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis) [Time Frame: Baseline (Day 1), 6 months (Day 197)]
DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis) [Time Frame: Baseline (Day 1), 6 months (Day 197)]
DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) [Time Frame: Baseline (Day 1), 6 months (Day 197)]
DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis) [Time Frame: Baseline (Day 1), 12 months (Day 365)]
DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) [Time Frame: Baseline (Day 1), 12 months (Day 365)]
DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF [Time Frame: From Day 1 through Day 365 (12 months)]
DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197 [Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365 [Time Frame: From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept [Time Frame: From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay) [Time Frame: Day 1 through day 365]
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 197 [Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 365 [Time Frame: From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept [Time Frame: From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197 [Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365 [Time Frame: From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365 [Time Frame: From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365 [Time Frame: From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study]
DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365 [Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study]
DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197 [Time Frame: DB Day 197]
DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365 [Time Frame: DB Day 365]
DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365 [Time Frame: Day 1 through day 365]
DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197 [Time Frame: DB Day 197]
DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365 [Time Frame: DB Day 365]
DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365 [Time Frame: DB Day 365]
OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI [Time Frame: Day 1 (Baseline), Day 729]
OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score [Time Frame: Baseline (Day 1), Day 365, Day 533, Day 729]
OL; Percentage of Participants Who Achieved Major Clinical Response [Time Frame: Defined from the date of achieving ACR 70 response to 6 months post response]
OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time [Time Frame: DB Day 197, Day 365, Day 533, Day 729]
OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time [Time Frame: OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729]
OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time [Time Frame: Baseline (Day 1), Day 365, Day 533, Day 729]
OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time [Time Frame: DB Days 365, 533, and 729]
Secondary ID(s)
IM101-043
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 21/01/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00095147
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