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Largo, Florida

  • Rheumatoid Arthritis

Purpose:

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.


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


Study is Available At:


Original ID:

IM101-043


NCT ID:

NCT00095147


Secondary ID:


Study Acronym:


Brief Title:

Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis


Official 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 Resp


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

431


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Study Dates

Start Date:February 2005
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:July 2009
Primary Completion Type:Actual
Verification Date:December 2010
Last Changed Date:December 21, 2010
First Received Date:November 1, 2004
First Results Date:October 26, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI
Time Frame:Day 1 (Baseline), Day 729
Safety Issues:False
Description:The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficult
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficult
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:Major Clinical Response was defined as a continuous ACR 70 for six months.
Outcome Type:Secondary Outcome
Measure:OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time
Time Frame:DB Day 197, Day 365, Day 533, Day 729
Safety Issues:False
Description:The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant glo
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thre
Outcome Type:Secondary Outcome
Measure:OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score
Time Frame:Baseline (Day 1), Day 365, Day 533, Day 729
Safety Issues:False
Description:The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thre
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:Infliximab levels were measured using a microplate enzyme-linked immunosorbant assay (ELISA) with infliximab bound to immobilized recombinant tumor necrosis factor (TNF)-alpha. Bound infliximab is detected utilizing a horseradish peroxidase-conjugated ant
Outcome Type:Secondary Outcome
Measure:DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)
Time Frame:Day 1 through day 365
Safety Issues:False
Description:ECL screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTL
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ &
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ &
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:Temperature (T) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.
Outcome Type:Secondary Outcome
Measure: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 i
Safety Issues:True
Description:Heart Rate (HR) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.
Outcome Type:Secondary Outcome
Measure: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 i
Safety Issues:True
Description:Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulator
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulator
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening,
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening,
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulator
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening,
Outcome Type:Secondary Outcome
Measure:DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365
Time Frame:DB Day 365
Safety Issues:False
Description:The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant glo
Outcome Type:Secondary Outcome
Measure:DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197
Time Frame:DB Day 197
Safety Issues:False
Description:The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant glo
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, a
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, a
Outcome Type:Secondary Outcome
Measure:DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)
Time Frame:Baseline (Day 1), 12 months (Day 365)
Safety Issues:False
Description:The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficult
Outcome Type:Secondary Outcome
Measure:DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)
Time Frame:Baseline (Day 1), 6 months (Day 197)
Safety Issues:False
Description:The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficult
Outcome Type:Secondary Outcome
Measure:DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365
Time Frame:DB Day 365
Safety Issues:False
Description:The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficult
Outcome Type:Secondary Outcome
Measure:DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197
Time Frame:DB Day 197
Safety Issues:False
Description:The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficult
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thre
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thre
Outcome Type:Primary Outcome
Measure:OL; Mean Temperature (T) During Open Label Period
Time Frame:Days 365, 729, 1121, and 1513
Safety Issues:True
Description:Temperature (T), units=degrees Celcius
Outcome Type:Primary Outcome
Measure:OL; Mean Heart Rate (HR) During Open Label Period
Time Frame:Days 365, 729, 1121, and 1513
Safety Issues:True
Description:Heart Rate (HR), units=beats per minute (bpm)
Outcome Type:Primary Outcome
Measure:OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period
Time Frame:Days 365, 729, 1121, and 1513
Safety Issues:True
Description:Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1513 in Electrolytes
Time Frame:Baseline (Day 1), Day 1513
Safety Issues:True
Description:Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1513 in Erythrocytes
Time Frame:Baseline (Day 1), Day 1513
Safety Issues:True
Description:Erythrocytes: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1513 in White Blood Cells
Time Frame:Baseline (Day 1), Day 1513
Safety Issues:True
Description:Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1513 in Hematocrit
Time Frame:Baseline (Day 1), Day 1513
Safety Issues:True
Description:Hematocrit: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1513 in Platelets
Time Frame:Baseline (Day 1), Day 1513
Safety Issues:True
Description:Platelets (PLT): <0.67 x LLN, >1.5 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin
Time Frame:Baseline (Day 1), Day 1513
Safety Issues:True
Description:Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1121 in Electrolytes
Time Frame:Baseline (Day 1), Day 1121
Safety Issues:True
Description:Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1121 in Erythrocytes
Time Frame:Baseline (Day 1), Day 1121
Safety Issues:True
Description:Erythrocytes: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1121 in White Blood Cells
Time Frame:Baseline (Day 1), Day 1121
Safety Issues:True
Description:Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1121 in Hematocrit
Time Frame:Baseline (Day 1), Day 1121
Safety Issues:True
Description:Hematocrit: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1121 in Platelets
Time Frame:Baseline (Day 1), Day 1121
Safety Issues:True
Description:Platelets (PLT): <0.67 x LLN, >1.5 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin
Time Frame:Baseline (Day 1), Day 1121
Safety Issues:True
Description:Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 729 in Electrolytes
Time Frame:Baseline (Day 1), Day 729
Safety Issues:True
Description:Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 729 in Erythrocytes
Time Frame:Baseline (Day 1), Day 729
Safety Issues:True
Description:Erythrocytes: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 729 in White Blood Cells
Time Frame:Baseline (Day 1), Day 729
Safety Issues:True
Description:Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 729 in Hematocrit
Time Frame:Baseline (Day 1), Day 729
Safety Issues:True
Description:Hematocrit: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 729 in Platelets
Time Frame:Baseline (Day 1), Day 729
Safety Issues:True
Description:Platelets (PLT): <0.67 x LLN, >1.5 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin
Time Frame:Baseline (Day 1), Day 729
Safety Issues:True
Description:Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Description:Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 365 in Electrolytes
Time Frame:Baseline (Day 1), Day 365
Safety Issues:True
Description:Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 365 in Erythrocytes
Time Frame:Baseline (Day 1), Day 365
Safety Issues:True
Description:Erythrocytes: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 365 in White Blood Cells
Time Frame:Baseline (Day 1), Day 365
Safety Issues:True
Description:Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 365 in Hematocrit
Time Frame:Baseline (Day 1), Day 365
Safety Issues:True
Description:Hematocrit: <0.75 x BL
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 365 in Platelets
Time Frame:Baseline (Day 1), Day 365
Safety Issues:True
Description:Platelets (PLT): <0.67 x LLN, >1.5 x ULN
Outcome Type:Primary Outcome
Measure:OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin
Time Frame:Baseline (Day 1), Day 365
Safety Issues:True
Description:Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:True
Description:Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blo
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:True
Description:High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN;
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulator
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:True
Description:AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening,
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:False
Description:The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The D

Study Interventions

Intervention Type:Drug
Name:Abatacept (ABA) + Methotrexate (MTX), double-blind
Description:Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.
Arm Name:Abatacept (ABA) + Methotrexate (MTX) (double-blind
Other Name:Orencia
Intervention Type:Drug
Name:Infliximab (INF) + MTX, DB
Description:Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.
Arm Name:Infliximab + MTX (DB)
Intervention Type:Drug
Name:Placebo (PLA) + MTX, DB
Description:Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.
Arm Name:Placebo + MTX (DB)
Intervention Type:Drug
Name:PLA + MTX switched to ABA+ MTX, DB
Description:Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months
Arm Name:Placebo + MTX switched to abatacept + MTX (DB)
Other Name:Orencia
Intervention Type:Drug
Name:ABA, open-label (OL)
Description:Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
Arm Name:Abatacept (open-label)
Other Name:Orencia

Study Arms

Study Arm Type:Active Comparator
Arm Name:Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB])
Description:Days 1-365
Study Arm Type:Active Comparator
Arm Name:Infliximab + MTX (DB)
Description:Days 1-365
Study Arm Type:Placebo Comparator
Arm Name:Placebo + MTX (DB)
Description:Days 1-197
Study Arm Type:Experimental
Arm Name:Placebo + MTX switched to abatacept + MTX (DB)
Description:Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365
Study Arm Type:Experimental
Arm Name:Abatacept (open-label)
Description:Days 365 to 729 All participants receive Active Drug

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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