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Trial record 35 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Methotrexate-Inadequate Response Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00559585
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : July 6, 2011
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: Subcutaneous (SC) Abatacept Drug: Intravenous (IV) Abatacept Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
Study Start Date : January 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Subcutaneous (SC) Abatacept
Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
Drug: Subcutaneous (SC) Abatacept
Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
Other Names:
  • Orencia
  • BMS-188667

Active Comparator: Intravenous (IV) Abatacept
Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
Drug: Intravenous (IV) Abatacept

Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).

500mg (for body weight up to 60 kg)

750 mg (body weight between 61 and 100 kg)

1g (body weight above 100 kg)infusions

Other Names:
  • Orencia
  • BMS-188667




Primary Outcome Measures :
  1. Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 [ Time Frame: Day 169 ]
    The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, 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).

  2. Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population [ Time Frame: Days 85, and 169 and postvisits on Days 28, 56, and 85 ]
    Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized.


Secondary Outcome Measures :
  1. Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 [ Time Frame: Day 169 ]
    The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% 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). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.

  2. Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 [ Time Frame: Day 169 ]
    The disability section of the full HAQ-DI 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.

  3. Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI [ Time Frame: Baseline to Day 169 ]
    The HAQ-DI includes 20 questions to assess physical function 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, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0.

  4. Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169 [ Time Frame: Day 169 ]
    The disability section of the full HAQ-DI 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-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.

  5. Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation [ Time Frame: Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. ]
    AE=any new untoward medical event or worsening of a preexisting medical condition that 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. Treatment-related SAE=possibly, probably, or certainly related to study drug

  6. Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died [ Time Frame: Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. ]
    AE=any new untoward medical event or worsening of a preexisting medical condition that 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.

  7. Double-blind Period: Number of Participants With AEs of Special Interest [ Time Frame: Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first. ]
    AE=any new untoward medical occurrence or worsening of a preexisting medical condition that 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: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions

  8. Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements [ Time Frame: Day 1 through end of short-term period (Day 169) ]
    Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.

  9. Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality [ Time Frame: Day 1 through end of short-term period (Day 169) ]
    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 and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <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.

  10. Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality [ Time Frame: Day 1 through end of short-term period (Day 169) ]
    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: >2* BL; creatinine: >1.5*BL

  11. Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality [ Time Frame: Day 1 through end of short-term period (Day 169) ]
    Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or <LLN

  12. Double-blind Period: Minimum Observed Serum Concentration of Abatacept [ Time Frame: Days 57, 85, 113, 120, 127, 134, 141, and 169 ]
  13. Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept [ Time Frame: Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period) ]
    Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169.

  14. Double-blind Period: Maximum Observed Serum Concentration of Abatacept [ Time Frame: End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous ]
  15. Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept [ Time Frame: End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous ]
    Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL).

  16. Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept [ Time Frame: Dosing interval between Days 113 and 141 (TAU=28 days) ]
  17. Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept [ Time Frame: Dosing Interval between Days 113 and 141 (TAU=28 days) ]
    Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.

  18. Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA) [ Time Frame: Days 85, and 169 and postvisits on Days 28, 56, and 85 ]
    Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4).

  19. Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period [ Time Frame: Baseline to Days 15, 29, 57, 85, 113, 141, and 169 ]
    C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit.

  20. Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized [ Time Frame: Days 85, and 169 and postvisits on Days 28, 56, and 85 ]
    An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment.

  21. Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline [ Time Frame: Baseline to Day 169 ]
    Rheumatoid factor (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.

  22. Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821 [ Time Frame: Days 169, 729, 1261, 1821 ]
    The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, 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).

  23. Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821 [ Time Frame: Days 169, 729, 1261, 1821 ]
    The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% 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). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.

  24. Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821 [ Time Frame: Days 169, 729, 1261, 1821 ]
    The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline.

  25. Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821 [ Time Frame: Days 169, 729, 1261, 1821 ]
    The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6.

  26. Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821 [ Time Frame: Days 169, 729, 1261, 1821 ]
    The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6.

  27. Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821 [ Time Frame: Days 169, 729, 1261, 1821 ]
    The disability section of the full HAQ includes 20 questions to assess physical function 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, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score.

  28. Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation [ Time Frame: End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014) ]
    AE=any new untoward medical event or worsening of a preexisting medical condition that 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. Treatment-related SAE=possibly, probably, or certainly related to study drug

  29. Open-Label LT Period: Number of Participants With AEs of Special Interest [ Time Frame: End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014) ]
    AE=any new untoward medical occurrence or worsening of a preexisting medical condition that 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: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.

  30. Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements [ Time Frame: End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014) ]
    Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.

  31. Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014) ]
    Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects who are considered methotrexate inadequate responders
  • 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

Exclusion Criteria:

  • Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
  • Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
  • Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
  • Subjects with severe chronic or recurrent bacterial infections
  • Subjects who have received treatment with rituximab

An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559585


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Locations
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United States, Alabama
Rheumatology Associates, Pc
Birmingham, Alabama, United States, 35205
Coastal Clinical Research, Inc
Mobile, Alabama, United States, 36608
United States, Arizona
Advanced Arthritis Care & Research
Scottsdale, Arizona, United States, 85258
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, United States, 85704
United States, Arkansas
St. Joseph'S Mercy Clinic
Hot Springs, Arkansas, United States, 71913
United States, California
Talbert Medical Group
Huntington Beach, California, United States, 92646
Allergy & Rheumatology Medical Clinic, Inc.
La Jolla, California, United States, 92037
Valerius Medical Group &Research Ctr. Of Greater Long Beach
Long Beach, California, United States, 90806
Stanford University School Of Medicine
Palo Alto, California, United States, 94304
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108
United States, Colorado
Boulder Medical Center
Boulder, Colorado, United States, 80304
Arthritis Assoc And Osteo Ctr Of Col Sprgs
Colorado Springs, Colorado, United States, 80910
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
Arthritis Center Of The Rockies, Pc
Loveland, Colorado, United States, 80538
United States, Connecticut
Guadagnoli, Germano
Bridgeport, Connecticut, United States, 06606
Joao Nascimento
Bridgeport, Connecticut, United States, 06606
Clinical Research Center Of Ct/Ny
Danbury, Connecticut, United States, 06810
United States, Florida
Arthritis And Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Arthritis & Osteoporosis Treatment Center, Pa
Orange Park, Florida, United States, 32073
Rheumatology Associates Of Central Florida
Orlando, Florida, United States, 32806
The Arthritis Center
Palm Harbor, Florida, United States, 34684
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239
United States, Georgia
Arthritis & Rheumatology Of Georgia,Pc
Atlanta, Georgia, United States, 30342
United States, Idaho
Boise Rheumatology/ Intermountain Research Center, Inc
Boise, Idaho, United States, 83702
Coeur D'Alene Arthrit Clin
Coeur D Alene, Idaho, United States, 83814
United States, Illinois
Quincy Medical Group
Quincy, Illinois, United States, 62301
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, United States, 61107
The Arthritis Center
Springfield, Illinois, United States, 62704
United States, Maryland
Klein And Associates, M.D., Pa
Cumberland, Maryland, United States, 21502
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Michigan
Shores Rheumatology, P. C.
St. Clair Shores, Michigan, United States, 48081
United States, Mississippi
Arthritis Assoicates Of Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Kansas City Internal Medicine
Lee'S Summit, Missouri, United States, 64086
United States, Nebraska
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Allergy And Arthritis Associates
Dover, New Jersey, United States, 07801
United States, New Mexico
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
Albuquerque Rehabilitation & Rheumatology Pc
Albuquerque, New Mexico, United States, 87102
United States, New York
The Center For Rheumatology, Llp
Albany, New York, United States, 12206
Southern Tier Arthritis & Rheumatism
Olean, New York, United States, 14760
Arthritis Health Associates
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville Rheumatology & Osteoporosis Research Asso P. A.
Asheville, North Carolina, United States, 28801
The Arthritis Clinic & Carolina Bone & Joint
Charlotte, North Carolina, United States, 28210
Rheumatology
Durham, North Carolina, United States, 27704
Physicians East, Pa
Greenville, North Carolina, United States, 27834
Carolina Pharmaceutical Research
Statesville, North Carolina, United States, 28625
Carolina Arthritis Associates
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma Center For Arthritis Therapy And Research
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Pro Research
Eugene, Oregon, United States, 97401
Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States, 18015
United States, Rhode Island
Rheumatology Associates
Providence, Rhode Island, United States, 02906
United States, South Carolina
Low Country Rheumatology, Pa
Charleston, South Carolina, United States, 29406
Columbia Arthritis Center
Columbia, South Carolina, United States, 29204
Carolina Health Specialists
Myrtle Beach, South Carolina, United States, 29572
Acme Research, Llc
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Arthritis Clinic
Jackson, Tennessee, United States, 38305
Rheumatology Consultants Pllc
Knoxville, Tennessee, United States, 37909
The Arthritis Group, Pc
Memphis, Tennessee, United States, 38104
St. Thomas Hospital Tower East
Nashville, Tennessee, United States, 37205
United States, Texas
Walter F. Chase
Austin, Texas, United States, 78705
Rheumatic Disease Clinical Research Center, Llc
Houston, Texas, United States, 77004
Accurate Clinical Research
Houston, Texas, United States, 77034
Texas Research Center
Sugarland, Texas, United States, 77479
United States, Virginia
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States, 22205
Center For Arthritis & Rheumatic Diseases, Pc
Chesapeake, Virginia, United States, 23320
United States, Washington
South Puget Sound Clinincal Research Center
Olympia, Washington, United States, 98502
Tacoma Center For Arthritis Research Ps
Tacoma, Washington, United States, 98405
Argentina
Local Institution
Ciudad Autonoma, Buenos Aires, Argentina, CP1425A WC
Local Institution
Rosario, Santa Fe, Santa Fe, Argentina, 2000
Local Institution
Buenos Aires, Argentina, 1015
Local Institution
Buenos Aires, Argentina, 1426
Local Institution
Buenos Aires, Argentina, C1428DQG
Local Institution
Cordoba, Argentina, 5000
Local Institution
Cordoba, Argentina, 5016
Local Institution
Santa Fe, Argentina, 3000
Local Institution
Tucuman, Argentina, 4000
Australia, New South Wales
Local Institution
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Local Institution
Cairns, Queensland, Australia, QLD 4870
Local Institution
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Local Institution
Woodville, South Australia, Australia, 5011
Australia, Victoria
Local Institution
Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
Local Institution
Shenton Park, Western Australia, Australia, 6008
Belgium
Local Institution
Bruxelles, Belgium, 1020
Local Institution
Bruxelles, Belgium, 1200
Local Institution
Hasselt, Belgium, 3500
Local Institution
Leuven, Belgium, 3000
Local Institution
Wilrijk, Belgium, 2610
Local Institution
Yvoir, Belgium, 5530
Brazil
Local Institution
Goiania, Goias, Brazil, 74110
Local Institution
Goiania, Goias, Brazil, 74605
Local Institution
Juiz De Fora, Minas Gerais, Brazil, 36010
Local Institution
Curitiba, Parana, Brazil, 80060240
Local Institution
Curitiba, Parana, Brazil, 80440
Local Institution
Recife, Pernambuco, Brazil, 50670
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 91610
Local Institution
Campinas, Sao Paulo, Brazil, 13059
Local Institution
Campinas, Sao Paulo, Brazil, 13083
Local Institution
Rio De Janeiro, Brazil, 20551
Local Institution
Sao Paulo, Brazil, 04027
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
Local Institution
St. John'S, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8N 1Y2
Local Institution
Hamilton, Ontario, Canada, L8N 2B6
Local Institution
Mississauga, Ontario, Canada, L5M 2V8
Local Institution
Ottawa, Ontario, Canada, K1H 1A2
Canada, Quebec
Local Institution
Ste-Foy, Quebec, Canada, G1V 3M7
Local Institution
Ste-Foy, Quebec, Canada, G1W 4R4
Local Institution
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7N 0W8
Chile
Local Institution
Santiago De Chile, Metropolitana, Chile, 0
Local Institution
Santiago De Chile, Metropolitana, Chile
Local Institution
Santiago, Metropolitana, Chile, 7500995
Local Institution
Santiago, Metropolitana, Chile
France
Local Institution
Bordeaux Cedex, France, 33076
Local Institution
Brest Cedex, France, 29609
Local Institution
Chambray Les Tours, France, 37170
Local Institution
Le Mans, France, 72037
Local Institution
Lille Cedex, France, 59037
Local Institution
Marseille, France, 13008
Local Institution
Nice Cedex 3, France, 06202
Local Institution
Paris Cedex 13, France, 75651
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Poitiers, France, 86021
Local Institution
Strasbourg Cedex, France, 67098
Germany
Local Institution
Berlin, Germany, 14059
Local Institution
Leipzig, Germany, 04103
Local Institution
Muenchen, Germany, 81541
Local Institution
Munchen, Germany, 80639
Greece
Local Institution
Heraklion Crete, Greece, 71110
Hungary
Local Institution
Budapest, Hungary, 1023
Local Institution
Debrecen, Hungary, 4012
India
Local Institution
Secunderabad, Andhra Pradesh, India, 500003
Local Institution
Navrangpura, Ahmedabad, Gujarat, India, 380009
Local Institution
Bangalore, Karnataka, India, 560 034
Local Institution
Bangalore, India, 560003
Local Institution
Hyderabad, India, 500004
Local Institution
Lucknow, India, 226014
Local Institution
New Delhi, India, 110029
Ireland
Local Institution
Dublin, Ireland, 4
Italy
Local Institution
Napoli, Italy, 80131
Local Institution
Padova, Italy, 35128
Local Institution
Pavia, Italy, 27100
Local Institution
Roma, Italy, 00168
Local Institution
Siena, Italy, 53100
Korea, Republic of
Local Institution
Seoul, Sungdong-Gu, Korea, Republic of, 133-792
Local Institution
Daegu, Korea, Republic of, 705-718
Local Institution
Daejeon, Korea, Republic of, 302-799
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of, 137-040
Mexico
Local Institution
Tijuana, Baja California, Mexico, 22320
Local Institution
Mexico City, Distrito Federal, Mexico, 06726
Local Institution
Guadalajara, Jalisco, Mexico, 0
Local Institution
Guadalajara, Jalisco, Mexico, 44100
Local Institution
Guadalajara, Jalisco, Mexico, 44620
Local Institution
Guadalajara, Jalisco, Mexico, 44690
Local Institution
Morelia, Michioacan, Mexico, 58270
Local Institution
Merida, Yucatan, Mexico, 97000
Local Institution
Aguascalientes, Mexico, 20230
Local Institution
Chihuahua, Mexico, 31000
Local Institution
Nuevo Leon, Mexico, 64020
Local Institution
Queretaro, Mexico, 76178
Local Institution
San Luis Potosi, Mexico, 78240
Netherlands
Local Institution
Leeuwarden, Netherlands, 8934 AD
Peru
Local Institution
Callao, Peru, CALLAO 2
Local Institution
Lima, Peru, 11
Local Institution
Lima, Peru, LIMA 13
Local Institution
Lima, Peru, LIMA 27
Local Institution
Lima, Peru, LIMA 33
Poland
Local Institution
Bialystok, Poland, 15-337
Local Institution
Bialystok, Poland, 15-461
Local Institution
Bydgoszcz, Poland, 85-168
Local Institution
Konskie, Poland, 26-200
Local Institution
Krakow, Poland, 30-510
Local Institution
Poznan, Poland, 60-218
Local Institution
Poznan, Poland, 60773
Local Institution
Torun, Poland, 87-100
Local Institution
Warszawa, Poland, 02-777
Russian Federation
Local Institution
Ekaterinburg, Russian Federation, 620102
Local Institution
Moscow, Russian Federation, 115522
Local Institution
Moscow, Russian Federation, 119049
Local Institution
Moscow, Russian Federation, 129327
Local Institution
Yaroslavl, Russian Federation, 150003
South Africa
Local Institution
Kempton Park, Gauteng, South Africa, 1619
Local Institution
Muckleneuk, Gauteng, South Africa, 0002
Local Institution
Muckleneuk, Gauteng, South Africa, 0132
Local Institution
Pretoria, Gauteng, South Africa, 0083
Local Institution
Durban, Kwa Zulu Natal, South Africa, 4001
Local Institution
Panorama, Western Cape, South Africa, 7500
Taiwan
Local Institution
Kaohsiung, Taiwan, 833
Local Institution
Taichung, Taiwan, 402
Local Institution
Taichung, Taiwan, 404
Local Institution
Taichung, Taiwan, 407
Turkey
Local Institution
Denizli, Turkey, 20070
Local Institution
Edirne, Turkey, 22030
Local Institution
Gaziantep, Turkey, 27310
United Kingdom
Local Institution
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Local Institution
Bridgend, Glamorgan, United Kingdom, CF31 1RQ
Local Institution
London, Greater London, United Kingdom, E11 1NR
Local Institution
Southampton, Hampshire, United Kingdom, SO16 6YD
Local Institution
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00559585     History of Changes
Other Study ID Numbers: IM101-174
EUDRACT # 2007-005434-37
First Posted: November 16, 2007    Key Record Dates
Results First Posted: July 6, 2011
Last Update Posted: November 9, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors