Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00124982
First received: June 30, 2005
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Abatacept
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Drug: Anti-Tumor Necrosing Factor (TNF) Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations [ Time Frame: Days 1-169 ] [ Designated as safety issue: Yes ]
    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with 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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug

  • Short-term Period: Number of Participants With AEs of Special Interest [ Time Frame: Days 1-169 ] [ Designated as safety issue: Yes ]
    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, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).

  • Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria [ Time Frame: Days 1-169 ] [ Designated as safety issue: Yes ]
    Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.

  • Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria [ Time Frame: Days 1-169 ] [ Designated as safety issue: Yes ]
    Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL

  • Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria [ Time Frame: Days 1-169 ] [ Designated as safety issue: Yes ]
    Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN

  • Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria [ Time Frame: Days 1-169 ] [ Designated as safety issue: Yes ]
    Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3

  • Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure [ Time Frame: Day 1 (Baseline) -Day 169 ] [ Designated as safety issue: Yes ]
  • Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) [ Time Frame: Days 1-169 ] [ Designated as safety issue: Yes ]
    Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.

  • Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with 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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug

  • Long-term Period: Number of Participants With AEs of Special Interest [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    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, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).

  • Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes:<0.75*BL; Platelets: <0.67*LLN/>1.5 * ULN, or if BL<LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN,use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.

  • Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase (GGT): >2*ULN, or if BL>ULN, use >3*BL; bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen (BUN): >2*BL; creatinine: >1.5*BL

  • Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN

  • Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3

  • Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL

  • Long-term Period: Change From Baseline in Hematocrit Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).

  • Long-term Period: Change From Baseline in Erythrocytes Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL

  • Long-term Period: Change From Baseline in Platelets (PLT) Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL

  • Long-term Period: Change From Baseline in White Blood Cells Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    Leukocytes NR=4.1 - 12.3*10^3 c/uL, MA is <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN. Neutrophils+bands MA is <1.0 * 10^3 c/uL. Eosinophils MA is >0.750 * 10^3 c/uL. Basophils MA is > 400 mm^3. Monocytes MA is >2000 mm^3. Lymphocytes MA is <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL

  • Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL

  • Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    Bilirubin NR=0.2-1.2 mg/dL, MA: >2* ULN, or if BL>ULN then use >4* BL. BUN NR=4.0-24.0 mg/dL, MA: >2*BL. Creatinine NR=0.4-1.2 mg/dL, MA: >1.5*BL. Ca NR=8.8-10.2 mg/dL, MA: <0.8*LLN/>1.2*ULN, or if BL<LLN then use 0.75*BL or >ULN, or if BL>ULN then use>1.25*BL or <LLN. P NR=2.8-4.0 mg/dL, MA: <0.75*LLN/ >1.25*ULN, or if BL<LLN then use 0.67*BL or >ULN, or if BL>ULN then use>1.33*BL or <LLN. Glu MA: <65 mg/dL/ >220 mg/dL. Uric acid MA: >1.5*ULN, or if BL>ULN then use >2*BL.

  • LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time [ Time Frame: BL, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
    Na NR=132 - 147 mEq/L, MA is 95* LLN/ >1.05* ULN, or if BL<LLN then use 0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN. K NR=3.3 - 5.5 mEq/L, MA is <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN. Cl NR=94 - 111 mEq/L, MA is <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN

  • Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    Measurements were taken in a seated position before and after abatacept infusion.

  • Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
    Measurements were taken in a seated position before and after abatacept infusion.

  • Long-term Period: Mean Heart Rate (HR) Over Time [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]
  • Long-term Period: Mean Temperature (T) Over Time [ Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169 [ Time Frame: BL, Day 169 ] [ Designated as safety issue: No ]
    The DAS 28 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= decrease in DAS28 score of >1.2 from baseline.

  • Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label [ Time Frame: BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ] [ Designated as safety issue: No ]
    The DAS 28 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). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

  • Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label [ Time Frame: BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ] [ Designated as safety issue: No ]
    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). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.

  • Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP) [ Time Frame: BL, Day 169 ] [ Designated as safety issue: No ]
    hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.

  • Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) [ Time Frame: BL, Day 169 ] [ Designated as safety issue: No ]
    RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.

  • Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: BL, Day 169 ] [ Designated as safety issue: No ]
    The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain 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. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).

  • Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response [ Time Frame: BL, Day 169 ] [ Designated as safety issue: No ]
    HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain 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. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.

  • Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores [ Time Frame: BL ] [ Designated as safety issue: No ]
    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.

  • Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores [ Time Frame: BL, Day 169 ] [ Designated as safety issue: No ]
    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.

  • Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS) [ Time Frame: BL ] [ Designated as safety issue: No ]
    The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.

  • Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS) [ Time Frame: BL, Day 169 ] [ Designated as safety issue: No ]
    The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.

  • Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time [ Time Frame: BL, Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    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= decrease in DAS28 score of >1.2 from baseline.

  • Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    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). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    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). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.

  • Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

  • Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.

  • Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [ Time Frame: BL (Day 0) ] [ Designated as safety issue: No ]
    HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain 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. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.

  • Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term [ Time Frame: Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain 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. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.

  • Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [ Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.

  • Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time [ Time Frame: BL, Days 365, 449, 533, 617, 729, 813 ] [ Designated as safety issue: No ]
    HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain 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. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.

  • Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [ Time Frame: BL (Day 0) ] [ Designated as safety issue: No ]
    SF-36 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 and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit

  • Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term [ Time Frame: Days 365 and 729 ] [ Designated as safety issue: No ]
    SF-36 measures health-related quality of life and 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 and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.

  • Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [ Time Frame: BL (Day 0), Days 365, 729 ] [ Designated as safety issue: No ]
    SF-36 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 and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.

  • LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA [ Time Frame: Days 1-813 ] [ Designated as safety issue: Yes ]
    Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.


Enrollment: 1286
Study Start Date: April 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label Abatacept (ABA)-Previous User
In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Drug: Abatacept
IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
Other Name: Orencia
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).
Experimental: Open-label ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Drug: Abatacept
IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
Other Name: Orencia
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).
Drug: Anti-Tumor Necrosing Factor (TNF) Therapy
Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months
Experimental: Long-term ABA
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Drug: Abatacept
IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.
Other Name: Orencia
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed double-blind portion of the IM101064 study.
  • Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
  • American College of Rheumatology (ACR) functional class I, II, III
  • Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months

Exclusion Criteria:

  • Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
  • History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124982

  Hide Study Locations
Locations
United States, Alabama
Local Institution
Birmingham, Alabama, United States
Local Institution
Huntsville, Alabama, United States
United States, Arizona
Local Institution
Paradise Valley, Arizona, United States
Local Institution
Peoria, Arizona, United States
Local Institution
Tucson, Arizona, United States
United States, California
Local Institution
Long Beach, California, United States
Local Institution
Palm Springs, California, United States
Local Institution
Palo Alto, California, United States
Local Institution
San Diego, California, United States
Local Institution
Santa Monica, California, United States
United States, Colorado
Local Institution
Colorado Springs, Colorado, United States
Local Institution
Denver, Colorado, United States
United States, Connecticut
Local Institution
Danbury, Connecticut, United States
Local Institution
Hamden, Connecticut, United States
Local Institution
Trumbull, Connecticut, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Aventura, Florida, United States
Local Institution
Clearwater, Florida, United States
Local Institution
Ft. Lauderdale, Florida, United States
Local Institution
Jupiter, Florida, United States
Local Institution
Largo, Florida, United States
Local Institution
Sarasota, Florida, United States
United States, Georgia
Local Institution
Atlanta, Georgia, United States
Local Institution
Blue Ridge, Georgia, United States
Local Institution
Macon, Georgia, United States
United States, Illinois
Local Institution
Morton Grove, Illinois, United States
United States, Indiana
Local Institution
Evansville, Indiana, United States
Local Institution
Indianapolis, Indiana, United States
United States, Iowa
Local Institution
Des Moines, Iowa, United States
United States, Kansas
Local Institution
Kansas City, Kansas, United States
Local Institution
Prairie Village, Kansas, United States
United States, Kentucky
Local Institution
Bowling Green, Kentucky, United States
Local Institution
Louisville, Kentucky, United States
United States, Louisiana
Local Institution
New Orleans, Louisiana, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
Local Institution
Peabody, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
Local Institution
Worcester, Massachusetts, United States
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States
Local Institution
East Lansing, Michigan, United States
Local Institution
Grand Rapids, Michigan, United States
Local Institution
Lansing, Michigan, United States
Local Institution
Petockey, Michigan, United States
United States, Minnesota
Local Institution
Minneapolis, Minnesota, United States
Local Institution
St. Paul, Minnesota, United States
United States, Nebraska
Local Institution
Omaha, Nebraska, United States
United States, Nevada
Local Institution
Las Vegas, Nevada, United States
United States, New Hampshire
Local Institution
Lebanon, New Hampshire, United States
Local Institution
Nashua, New Hampshire, United States
United States, New Jersey
Local Institution
Cherry Hill, New Jersey, United States
Local Institution
Dover, New Jersey, United States
Local Institution
Manalapan, New Jersey, United States
Local Institution
New Brunswick, New Jersey, United States
Local Institution
Somerset, New Jersey, United States
Local Institution
Teaneck, New Jersey, United States
Local Institution
Voorhees, New Jersey, United States
United States, New York
Local Institution
Albany, New York, United States
Local Institution
Brooklyn, New York, United States
Local Institution
Hewlett, New York, United States
Local Institution
Lake Success, New York, United States
Local Institution
Mineola, New York, United States
Local Institution
New York, New York, United States
Local Institution
Olean, New York, United States
Local Institution
Orchard Park, New York, United States
Local Institution
Rochester, New York, United States
Local Institution
Schenectady, New York, United States
Local Institution
Smithtown, New York, United States
Local Institution
Syracuse, New York, United States
United States, North Carolina
Local Institution
Asheville, North Carolina, United States
Local Institution
Charlotte, North Carolina, United States
Local Institution
Hickory, North Carolina, United States
Local Institution
Wilmington, North Carolina, United States
United States, North Dakota
Local Institution
Bismark, North Dakota, United States
United States, Ohio
Local Institution
Akron, Ohio, United States
Local Institution
Beachwood, Ohio, United States
Local Institution
Cleveland, Ohio, United States
Local Institution
Columbus, Ohio, United States
Local Institution
Mayfield Village, Ohio, United States
Local Institution
Youngstown, Ohio, United States
United States, Oregon
Local Institution
Portland, Oregon, United States
United States, Pennsylvania
Local Institution
Bala Cynwyd, Pennsylvania, United States
Local Institution
Bethlehem, Pennsylvania, United States
Local Institution
Camp Hill, Pennsylvania, United States
Local Institution
Duncansville, Pennsylvania, United States
Local Institution
Erie, Pennsylvania, United States
Local Institution
Meadville, Pennsylvania, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Local Institution
West Reading, Pennsylvania, United States
Local Institution
Wexford, Pennsylvania, United States
Local Institution
Willow Grove, Pennsylvania, United States
United States, Rhode Island
Local Institution
Providence, Rhode Island, United States
United States, South Carolina
Local Institution
Myrtle Beach, South Carolina, United States
Local Institution
Simpsonville, South Carolina, United States
United States, South Dakota
Local Institution
Sioux Falls, South Dakota, United States
United States, Tennessee
Local Institution
Hixson, Tennessee, United States
Local Institution
Knoxville, Tennessee, United States
United States, Texas
Local Institution
Austin, Texas, United States
Local Institution
Corpus Christi, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Galveston, Texas, United States
Local Institution
Houston, Texas, United States
Local Institution
Lubbock, Texas, United States
Local Institution
San Antonio, Texas, United States
Local Institution
Sugarland, Texas, United States
United States, Virginia
Local Institution
Burke, Virginia, United States
Local Institution
Chesapeake, Virginia, United States
Local Institution
Fairfax, Virginia, United States
Local Institution
Salem, Virginia, United States
United States, Washington
Local Institution
Seattle, Washington, United States
Local Institution
Vancouver, Washington, United States
United States, Wisconsin
Local Institution
Glendale, Wisconsin, United States
Local Institution
La Crosse, Wisconsin, United States
Local Institution
Madison, Wisconsin, United States
Belgium
Local Institution
Bruxelles, Belgium
Local Institution
Leuven, Belgium
Czech Republic
Local Institution
Prague 2, Czech Republic
France
Local Institution
Boisguillaume, France
Local Institution
Bordeaux Cedex, France
Local Institution
Brest Cedex, France
Local Institution
Chambray Les Tours, France
Local Institution
Montpellier, France
Local Institution
Nice Cedex 03, France
Local Institution
Paris, France
Local Institution
Rennes Cedex 9, France
Local Institution
Strasbourg Cedex, France
Local Institution
Toulouse, France
Germany
Local Institution
Freiburg, Germany
Local Institution
Hamburg, Germany
Local Institution
Kiel, Germany
Local Institution
Leipzig, Germany
Local Institution
Tuebingen, Germany
Ireland
Local Institution
Cork, Ireland
Italy
Local Institution
Genova, Italy
Local Institution
Milano, Italy
Local Institution
Torino, Italy
Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Distrito Federal, Mexico
Spain
Local Institution
Alicante, Spain
Local Institution
Barcelona, Spain
Local Institution
Guipuzcoa, Spain
Local Institution
Madrid, Spain
Local Institution
Santander, Spain
Local Institution
Valencia, Spain
United Kingdom
Local Institution
Cambridge, Cambridgeshire, United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom
Local Institution
Maidstone, Kent, United Kingdom
Local Institution
Leeds, North Yorkshire, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00124982     History of Changes
Other Study ID Numbers: IM101-064
Study First Received: June 30, 2005
Results First Received: February 18, 2011
Last Updated: February 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014