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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/NCT00095147
Registration number
NCT00095147
Ethics application status
Date submitted
1/11/2004
Date registered
2/11/2004
Date last updated
24/03/2015
Titles & IDs
Public title
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
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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
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Secondary ID [1]
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IM101-043
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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:
Rheumatoid Arthritis
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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 (ABA) + Methotrexate (MTX), double-blind (DB)
Treatment: Drugs - Infliximab (INF) + MTX, DB
Treatment: Drugs - Placebo (PLA) + MTX, DB
Treatment: Drugs - PLA + MTX switched to ABA+ MTX, DB
Treatment: Drugs - ABA, open-label (OL)
Active Comparator: Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB]) - Days 1-365
Active Comparator: Infliximab + MTX (DB) - Days 1-365
Placebo Comparator: Placebo + MTX (DB) - Days 1-197
Experimental: Placebo + MTX switched to abatacept + MTX (DB) - Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365
Experimental: Abatacept (open-label) - Days 365 to 729 All participants receive Active Drug
Treatment: Drugs: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.
Treatment: Drugs: Infliximab (INF) + MTX, DB
Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.
Treatment: Drugs: Placebo (PLA) + MTX, DB
Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.
Treatment: Drugs: PLA + MTX switched to ABA+ MTX, DB
Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months
Treatment: Drugs: ABA, open-label (OL)
Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
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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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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)
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Assessment method [1]
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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 DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.
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Timepoint [1]
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Baseline (Day 1), 6 months (Day 197)
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Primary outcome [2]
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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
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Assessment method [2]
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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, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
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Timepoint [2]
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From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)
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Primary outcome [3]
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OL; Number of Participants With AEs of Special Interest
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Assessment method [3]
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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 immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).
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Timepoint [3]
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From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)
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Primary outcome [4]
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OL; Number of Participants With Select Hematologic Laboratory Abnormalities
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Assessment method [4]
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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; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; monocytes: >2000 mm3; eosinophils: >0.750 x 10^3 c/uL;
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Timepoint [4]
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From Day 366 through end of OL (range from 1.9 months to 42.3 months)
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Primary outcome [5]
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OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities
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Assessment method [5]
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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; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL
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Timepoint [5]
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From Day 366 through end of OL (range from 1.9 months to 42.3 months)
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Primary outcome [6]
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OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin
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Assessment method [6]
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Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
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Timepoint [6]
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Baseline (Day 1), Day 365
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Primary outcome [7]
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OL; Mean Change From Baseline to Day 365 in Platelets
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Assessment method [7]
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Platelets (PLT): <0.67 x LLN, >1.5 x ULN
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Timepoint [7]
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Baseline (Day 1), Day 365
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Primary outcome [8]
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OL; Mean Change From Baseline to Day 365 in Hematocrit
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Assessment method [8]
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Hematocrit: <0.75 x BL
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Timepoint [8]
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Baseline (Day 1), Day 365
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Primary outcome [9]
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OL; Mean Change From Baseline to Day 365 in White Blood Cells
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline (Day 1), Day 365
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Primary outcome [10]
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OL; Mean Change From Baseline to Day 365 in Erythrocytes
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Assessment method [10]
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Erythrocytes: <0.75 x BL
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Timepoint [10]
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Baseline (Day 1), Day 365
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Primary outcome [11]
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OL; Mean Change From Baseline to Day 365 in Electrolytes
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Assessment method [11]
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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
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Timepoint [11]
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Baseline (Day 1), Day 365
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Primary outcome [12]
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OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
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Assessment method [12]
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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: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;
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Timepoint [12]
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Baseline (Day 1), Day 365
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Primary outcome [13]
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OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
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Assessment method [13]
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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
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Timepoint [13]
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Baseline (Day 1), Day 365
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Primary outcome [14]
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OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin
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Assessment method [14]
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Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
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Timepoint [14]
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Baseline (Day 1), Day 729
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Primary outcome [15]
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OL; Mean Change From Baseline to Day 729 in Platelets
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Assessment method [15]
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Platelets (PLT): <0.67 x LLN, >1.5 x ULN
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Timepoint [15]
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Baseline (Day 1), Day 729
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Primary outcome [16]
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OL; Mean Change From Baseline to Day 729 in Hematocrit
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Assessment method [16]
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Hematocrit: <0.75 x BL
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Timepoint [16]
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Baseline (Day 1), Day 729
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Primary outcome [17]
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OL; Mean Change From Baseline to Day 729 in White Blood Cells
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline (Day 1), Day 729
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Primary outcome [18]
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OL; Mean Change From Baseline to Day 729 in Erythrocytes
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Assessment method [18]
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Erythrocytes: <0.75 x BL
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Timepoint [18]
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Baseline (Day 1), Day 729
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Primary outcome [19]
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OL; Mean Change From Baseline to Day 729 in Electrolytes
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Assessment method [19]
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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
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Timepoint [19]
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Baseline (Day 1), Day 729
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Primary outcome [20]
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OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
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Assessment method [20]
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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: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;
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Timepoint [20]
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Baseline (Day 1), Day 729
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Primary outcome [21]
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OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
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Assessment method [21]
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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
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Timepoint [21]
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Baseline (Day 1), Day 729
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Primary outcome [22]
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OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin
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Assessment method [22]
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Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
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Timepoint [22]
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Baseline (Day 1), Day 1121
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Primary outcome [23]
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OL; Mean Change From Baseline to Day 1121 in Platelets
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Assessment method [23]
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Platelets (PLT): <0.67 x LLN, >1.5 x ULN
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Timepoint [23]
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Baseline (Day 1), Day 1121
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Primary outcome [24]
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OL; Mean Change From Baseline to Day 1121 in Hematocrit
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Assessment method [24]
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Hematocrit: <0.75 x BL
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Timepoint [24]
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Baseline (Day 1), Day 1121
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Primary outcome [25]
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OL; Mean Change From Baseline to Day 1121 in White Blood Cells
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Assessment method [25]
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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.
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Timepoint [25]
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Baseline (Day 1), Day 1121
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Primary outcome [26]
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OL; Mean Change From Baseline to Day 1121 in Erythrocytes
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Assessment method [26]
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Erythrocytes: <0.75 x BL
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Timepoint [26]
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Baseline (Day 1), Day 1121
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Primary outcome [27]
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OL; Mean Change From Baseline to Day 1121 in Electrolytes
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Assessment method [27]
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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
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Timepoint [27]
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Baseline (Day 1), Day 1121
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Primary outcome [28]
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OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
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Assessment method [28]
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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: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;
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Timepoint [28]
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Baseline (Day 1), Day 1121
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Primary outcome [29]
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OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
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Assessment method [29]
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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
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Timepoint [29]
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Baseline (Day 1), Day 1121
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Primary outcome [30]
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OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin
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Assessment method [30]
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Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN
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Timepoint [30]
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Baseline (Day 1), Day 1513
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Primary outcome [31]
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OL; Mean Change From Baseline to Day 1513 in Platelets
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Assessment method [31]
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Platelets (PLT): <0.67 x LLN, >1.5 x ULN
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Timepoint [31]
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Baseline (Day 1), Day 1513
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Primary outcome [32]
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OL; Mean Change From Baseline to Day 1513 in Hematocrit
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Assessment method [32]
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Hematocrit: <0.75 x BL
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Timepoint [32]
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Baseline (Day 1), Day 1513
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Primary outcome [33]
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OL; Mean Change From Baseline to Day 1513 in White Blood Cells
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Assessment method [33]
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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.
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Timepoint [33]
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Baseline (Day 1), Day 1513
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Primary outcome [34]
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OL; Mean Change From Baseline to Day 1513 in Erythrocytes
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Assessment method [34]
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Erythrocytes: <0.75 x BL
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Timepoint [34]
0
0
Baseline (Day 1), Day 1513
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Primary outcome [35]
0
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OL; Mean Change From Baseline to Day 1513 in Electrolytes
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Assessment method [35]
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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
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Timepoint [35]
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0
Baseline (Day 1), Day 1513
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Primary outcome [36]
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OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid
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Assessment method [36]
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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: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;
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Timepoint [36]
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Baseline (Day 1), Day 1513
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Primary outcome [37]
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OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase
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Assessment method [37]
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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
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Timepoint [37]
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Baseline (Day 1), Day 1513
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Primary outcome [38]
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OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period
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Assessment method [38]
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Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)
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Timepoint [38]
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Days 365, 729, 1121, and 1513
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Primary outcome [39]
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OL; Mean Heart Rate (HR) During Open Label Period
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Assessment method [39]
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Heart Rate (HR), units=beats per minute (bpm)
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Timepoint [39]
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Days 365, 729, 1121, and 1513
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Primary outcome [40]
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OL; Mean Temperature (T) During Open Label Period
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Assessment method [40]
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Temperature (T), units=degrees Celcius
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Timepoint [40]
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Days 365, 729, 1121, and 1513
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Secondary outcome [1]
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DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)
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Assessment method [1]
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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 thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.
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Timepoint [1]
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Baseline (Day 1), 6 months (Day 197)
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Secondary outcome [2]
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DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF
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Assessment method [2]
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0
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 thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Clinically significant response= decrease in DAS28 score of >1.2 from baseline. DAS28 AUC can be calculated from the DAS28 score versus time curve, which provides an assessment of changes in disease activity over time.
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Timepoint [2]
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From Day 1 through Day 365 (12 months)
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Secondary outcome [3]
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DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197
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Assessment method [3]
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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 difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
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Timepoint [3]
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0
DB Day 197
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Secondary outcome [4]
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0
DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365
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Assessment method [4]
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0
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 difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
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Timepoint [4]
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0
DB Day 365
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Secondary outcome [5]
0
0
DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)
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Assessment method [5]
0
0
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 difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Query!
Timepoint [5]
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0
Baseline (Day 1), 6 months (Day 197)
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Secondary outcome [6]
0
0
DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)
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Assessment method [6]
0
0
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 difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Query!
Timepoint [6]
0
0
Baseline (Day 1), 12 months (Day 365)
Query!
Secondary outcome [7]
0
0
DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)
Query!
Assessment method [7]
0
0
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, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Query!
Timepoint [7]
0
0
Baseline (Day 1), 6 months (Day 197)
Query!
Secondary outcome [8]
0
0
DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)
Query!
Assessment method [8]
0
0
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, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Query!
Timepoint [8]
0
0
Baseline (Day 1), 12 months (Day 365)
Query!
Secondary outcome [9]
0
0
DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365
Query!
Assessment method [9]
0
0
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 activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL)
Query!
Timepoint [9]
0
0
DB Day 365
Query!
Secondary outcome [10]
0
0
DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197
Query!
Assessment method [10]
0
0
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 global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.
Query!
Timepoint [10]
0
0
DB Day 197
Query!
Secondary outcome [11]
0
0
DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365
Query!
Assessment method [11]
0
0
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 global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.
Query!
Timepoint [11]
0
0
DB Day 365
Query!
Secondary outcome [12]
0
0
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
Query!
Assessment method [12]
0
0
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, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Query!
Timepoint [12]
0
0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [13]
0
0
DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197
Query!
Assessment method [13]
0
0
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 immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).
Query!
Timepoint [13]
0
0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [14]
0
0
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
Query!
Assessment method [14]
0
0
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, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Query!
Timepoint [14]
0
0
From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [15]
0
0
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
Query!
Assessment method [15]
0
0
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, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Query!
Timepoint [15]
0
0
From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [16]
0
0
DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365
Query!
Assessment method [16]
0
0
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 immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).
Query!
Timepoint [16]
0
0
From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [17]
0
0
DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept
Query!
Assessment method [17]
0
0
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 immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).
Query!
Timepoint [17]
0
0
From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [18]
0
0
DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
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
Query!
Secondary outcome [19]
0
0
DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365
Query!
Assessment method [19]
0
0
Heart Rate (HR) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.
Query!
Timepoint [19]
0
0
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
Query!
Secondary outcome [20]
0
0
DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365
Query!
Assessment method [20]
0
0
Temperature (T) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.
Query!
Timepoint [20]
0
0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [21]
0
0
DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197
Query!
Assessment method [21]
0
0
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/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL
Query!
Timepoint [21]
0
0
From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [22]
0
0
DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365
Query!
Assessment method [22]
0
0
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/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL
Query!
Timepoint [22]
0
0
From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study
Query!
Secondary outcome [23]
0
0
DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)
Query!
Assessment method [23]
0
0
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 CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
Query!
Timepoint [23]
0
0
Day 1 through day 365
Query!
Secondary outcome [24]
0
0
DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365
Query!
Assessment method [24]
0
0
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 anti-human IgG Fc(fragment, crystallizable region)-specific). The enzyme turns over the substrate O-phenlenediamine to a chromogenic product that is measured at 490 nm. The cut-off value was 1.40 ug/mL; this was based on the mean (+ 3 SD) value in serum samples from 40 participants who had never received infliximab.
Query!
Timepoint [24]
0
0
Day 1 through day 365
Query!
Secondary outcome [25]
0
0
OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score
Query!
Assessment method [25]
0
0
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 thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.
Query!
Timepoint [25]
0
0
Baseline (Day 1), Day 365, Day 533, Day 729
Query!
Secondary outcome [26]
0
0
OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time
Query!
Assessment method [26]
0
0
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 thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.
Query!
Timepoint [26]
0
0
Baseline (Day 1), Day 365, Day 533, Day 729
Query!
Secondary outcome [27]
0
0
OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time
Query!
Assessment method [27]
0
0
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 activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute >5.1 or <0.6 change from BL)
Query!
Timepoint [27]
0
0
DB Days 365, 533, and 729
Query!
Secondary outcome [28]
0
0
OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time
Query!
Assessment method [28]
0
0
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 global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.
Query!
Timepoint [28]
0
0
DB Day 197, Day 365, Day 533, Day 729
Query!
Secondary outcome [29]
0
0
OL; Percentage of Participants Who Achieved Major Clinical Response
Query!
Assessment method [29]
0
0
Major Clinical Response was defined as a continuous ACR 70 for six months.
Query!
Timepoint [29]
0
0
Defined from the date of achieving ACR 70 response to 6 months post response
Query!
Secondary outcome [30]
0
0
OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time
Query!
Assessment method [30]
0
0
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 difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Query!
Timepoint [30]
0
0
OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729
Query!
Secondary outcome [31]
0
0
OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI
Query!
Assessment method [31]
0
0
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 difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Query!
Timepoint [31]
0
0
Day 1 (Baseline), Day 729
Query!
Eligibility
Key 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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
431
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Cairns
Query!
Recruitment hospital [2]
0
0
Local Institution - Cotton Tree
Query!
Recruitment hospital [3]
0
0
Local Institution - Clayton
Query!
Recruitment hospital [4]
0
0
Local Institution - Heidelberg
Query!
Recruitment hospital [5]
0
0
Local Institution - Malvern
Query!
Recruitment hospital [6]
0
0
Local Institution - Parkville
Query!
Recruitment hospital [7]
0
0
Local Institution - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Cairns
Query!
Recruitment postcode(s) [2]
0
0
- Cotton Tree
Query!
Recruitment postcode(s) [3]
0
0
- Clayton
Query!
Recruitment postcode(s) [4]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
- Malvern
Query!
Recruitment postcode(s) [6]
0
0
- Parkville
Query!
Recruitment postcode(s) [7]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Cordoba
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Tucuman
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Parana
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Pernambuco
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Rio Grande Do Sul
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Rio De Janeiro
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Sao Paulo
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Alberta
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Manitoba
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Newfoundland and Labrador
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Quebec
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Saskatchewan
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Kitchener
Query!
Country [29]
0
0
Czech Republic
Query!
State/province [29]
0
0
Prague 2
Query!
Country [30]
0
0
Denmark
Query!
State/province [30]
0
0
Copenhagen
Query!
Country [31]
0
0
Korea, Republic of
Query!
State/province [31]
0
0
Seoul
Query!
Country [32]
0
0
Mexico
Query!
State/province [32]
0
0
Baja California
Query!
Country [33]
0
0
Mexico
Query!
State/province [33]
0
0
Distrito Federal
Query!
Country [34]
0
0
Mexico
Query!
State/province [34]
0
0
Guanajuato
Query!
Country [35]
0
0
Mexico
Query!
State/province [35]
0
0
Jalisco
Query!
Country [36]
0
0
Mexico
Query!
State/province [36]
0
0
Nuevo Leon
Query!
Country [37]
0
0
Mexico
Query!
State/province [37]
0
0
San Luis Potosi
Query!
Country [38]
0
0
Peru
Query!
State/province [38]
0
0
Lima
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Poznan
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Sopot
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Warszawa
Query!
Country [42]
0
0
Puerto Rico
Query!
State/province [42]
0
0
Rio Piedras
Query!
Country [43]
0
0
Russian Federation
Query!
State/province [43]
0
0
Moscow
Query!
Country [44]
0
0
South Africa
Query!
State/province [44]
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Gauteng
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South Africa
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Kwa Zulu Natal
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South Africa
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Western Cape
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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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Cordoba
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Spain
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Madrid
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Sweden
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Falun
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Sweden
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Linkoping
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Uppsala
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Switzerland
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Bern
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Switzerland
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St. Gallen
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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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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00095147
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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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/NCT00095147
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