Remission and Joint Damage Progression in Early Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00122382
First received: July 19, 2005
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Abatacept
Drug: placebo
Drug: methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.

  • Mean Change From Baseline in Radiographic Total Score to Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

  • Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period [ Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first. ] [ Designated as safety issue: Yes ]
    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

  • Number of Participants With Serious Adverse Events Reported During the Open-Label Period [ Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first. ] [ Designated as safety issue: Yes ]
    SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

  • Number of Participants With SAEs With an Outcome of Death During the Open-label Period [ Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first. ] [ Designated as safety issue: Yes ]
    Any untoward medical occurrence (SAE) that resulted in death

  • Incidence Rates of Autoimmune Disorders in ABA-Treated Participants [ Time Frame: Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first). ] [ Designated as safety issue: Yes ]
    The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.

  • Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants [ Time Frame: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first). ] [ Designated as safety issue: Yes ]
    The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.

  • Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants [ Time Frame: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first). ] [ Designated as safety issue: Yes ]
    The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.

  • Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period [ Time Frame: Open-Label Period (Month 12 to Month 24) ] [ Designated as safety issue: Yes ]
    There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.

  • Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period [ Time Frame: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first. ] [ Designated as safety issue: Yes ]
    Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.

  • Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period [ Time Frame: Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first. ] [ Designated as safety issue: Yes ]
    Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL


Secondary Outcome Measures:
  • Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].

  • Number of Participants With Major Clinical Response (MCR) at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).

  • Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.

  • Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function 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; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.

  • Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.

  • Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value

  • Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA) [ Time Frame: includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first. ] [ Designated as safety issue: No ]
    Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).

  • Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA [ Time Frame: Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first. ] [ Designated as safety issue: No ]
    Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).

  • Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function 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; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.

  • Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.

  • Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

  • Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12 [ Time Frame: Month 12, Month 24 ] [ Designated as safety issue: No ]
    Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

  • Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score) [ Time Frame: Baseline, Month 12, Month 24 ] [ Designated as safety issue: No ]
    Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period [ Time Frame: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first. ] [ Designated as safety issue: Yes ]
    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

  • Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period [ Time Frame: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first. ] [ Designated as safety issue: Yes ]
    Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria


Enrollment: 1052
Study Start Date: July 2005
Study Completion Date: February 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ABA + MTX
abatacept 10 mg/kg intravenous (IV) + methotrexate
Drug: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
Drug: methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Active Comparator: Placebo (PLA) + MTX
placebo IV + methotrexate
Drug: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
Drug: placebo
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months
Drug: methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent.
  • C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)
  • Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
  • Tender joints >=12 and swollen joints >=10

Exclusion Criteria:

  • Women and men who are not willing to use birth control
  • Diagnosed with other rheumatic disease
  • History of cancer within 5 years
  • Active tuberculosis
  • Treatment with another investigation drug within 28 days
  • Active bacterial or viral infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122382

  Hide Study Locations
Locations
United States, Alabama
Rheumatology Associates Of North Alabama
Huntsville, Alabama, United States, 35801
United States, California
Talbert Medical Group
Huntington Beach, California, United States, 92646
United States, Colorado
Arthritis Assoc And Osteo Ctr Of Col Sprgs
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
New England Research Associates, Llc
Trumbull, Connecticut, United States, 06611
United States, Indiana
Diagnostic Rheumatology And Research
Indianapolis, Indiana, United States, 46227
United States, Maryland
Osteoporosis And Clinical Trials Center
Cumberland, Maryland, United States, 21502
Malamet & Klein, Md, Pa
Hagerstown, Maryland, United States, 21740
United States, Nebraska
Arthritis Center Of Nebraska
Lincoln, Nebraska, United States, 68516
United States, New York
Regional Rheumatology Associates
Binghamton, New York, United States, 13905
United States, North Carolina
Carolina Bone & Joint
Charlotte, North Carolina, United States, 28210
Physicians East, Pa
Greenville, North Carolina, United States, 27834
Carolina Pharmaceutical Research
Statesville, North Carolina, United States, 28625
United States, Oklahoma
Lion Research
Norman, Oklahoma, United States, 73071
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Low Country Research Center
Charleston, South Carolina, United States, 29406
United States, Texas
Walter F Chase Md Pa
Austin, Texas, United States, 78705
United States, Virginia
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States, 22205
Australia, Victoria
Local Institution
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Local Institution
Shenton Park, Western Australia, Australia, 6008
Belgium
Local Institution
Antwerpen, Belgium, 2020
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Bruxelles, Belgium, 1200
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Bruxelles, Belgium, 1070
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Hasselt, Belgium, 3500
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Leuven, Belgium, 3000
Brazil
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Goiania, Goias, Brazil, 74043
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Curitiba, Parana, Brazil, 80060
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Rio De Janeiro - Rj, Rio De Janeiro, Brazil, 20551
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Porto Alegre, Rio Grande Do Sul, Brazil, 91610
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Sao Paulo, Brazil, 04039
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Sao Paulo, Brazil, 04230
Canada, Newfoundland and Labrador
Local Institution
St. John'S, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Ontario
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Kitchener, Ontario, Canada, N2M 5N6
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Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
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Montreal, Quebec, Canada, H2L 1S6
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Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Local Institution
Quebec, Canada, G1V 3M7
Czech Republic
Local Institution
Prague 2, Czech Republic, 128 50
France
Local Institution
Dijon, France, 21000
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Montpellier Cedex 5, France, 34295
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Nice Cedex 03, France, 06202
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Strasbourg Cedex, France, 67098
Germany
Local Institution
Berlin, Germany, 14059
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Hamburg, Germany, 22081
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Leipzig, Germany, 04103
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Leipzig, Germany, 04229
Italy
Local Institution
Jesi(Ancona), Italy, 60055
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Milano, Italy, 20157
Korea, Republic of
Local Institution
Anyang, Korea, Republic of, 431-070
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Daegu, Korea, Republic of, 705-718
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Daejeon, Korea, Republic of, 302-799
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 137-040
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Seoul, Korea, Republic of, 133-792
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Seoul, Korea, Republic of, 110-744
Mexico
Local Institution
D.f., Distrito Federal, Mexico, 06700
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Metepec, Estado De Mexico, Mexico, 52140
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Leon, Guanajuato, Mexico, 37000
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Guadalajara, Jalisco, Mexico, 44340
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Guadalajara, Jalisco, Mexico, 44690
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Guadalajara, Jalisco, Mexico, 42650
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Morelia, Michioacan, Mexico, 58000
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Cuernavaca, Morelos, Mexico, 62270
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Monterrey, Nuevo Leon, Mexico, 64020
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Chihuahua, Mexico, 31000
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San Luis Potosi, Mexico, 78240
Netherlands
Local Institution
Amsterdam, Netherlands, 1081 HV
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Leiden, Netherlands, 2300 RC
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Nijmegen, Netherlands, 6500 HB
Poland
Local Institution
Poznan, Poland, 60773
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Poznan, Poland, 61-545
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Warszawa, Poland, 02-637
Puerto Rico
Local Institution
Ponce, Puerto Rico, 00716
Russian Federation
Local Institution
Moscow, Russian Federation, 115522
Local Institution
Moscow, Russian Federation, 119049
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9317
Local Institution
Muckleneuk, Gauteng, South Africa, 0002
Local Institution
Pretoria, Gauteng, South Africa, 0084
Local Institution
Berea, Kwa Zulu Natal, South Africa, 4001
Local Institution
Panorama, Western Cape, South Africa, 7506
Spain
Local Institution
A Coruna, Spain, 15706
Local Institution
Santander, Spain, 39008
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Sevilla, Spain, 41071
United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom, M13 9WL
Local Institution
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Local Institution
Leeds, North Yorkshire, United Kingdom, LS7 4SA
Local Institution
Newcastle, Northumberland, United Kingdom, NE1 4LP
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00122382     History of Changes
Other Study ID Numbers: IM101-023
Study First Received: July 19, 2005
Results First Received: May 3, 2010
Last Updated: November 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
abatacept, methotrexate, erosive RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abatacept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on April 15, 2014