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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00122382
Registration number
NCT00122382
Ethics application status
Date submitted
19/07/2005
Date registered
22/07/2005
Date last updated
16/11/2010
Titles & IDs
Public title
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
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Scientific 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
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Secondary ID [1]
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IM101-023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - placebo
Treatment: Drugs - methotrexate
Active Comparator: ABA + MTX - abatacept 10 mg/kg intravenous (IV) + methotrexate
Active Comparator: Placebo (PLA) + MTX - placebo IV + methotrexate
Treatment: Drugs: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
Treatment: Drugs: placebo
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12
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Assessment method [1]
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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.
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Timepoint [1]
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Month 12
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Primary outcome [2]
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Mean Change From Baseline in Radiographic Total Score to Month 12
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Month 12
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Primary outcome [3]
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Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period
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Assessment method [3]
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AE=any new untoward medical occurrence or worsening of a pre-existing medical condition 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.
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Timepoint [3]
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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.
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Primary outcome [4]
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Number of Participants With Serious Adverse Events Reported During the Open-Label Period
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Assessment method [4]
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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.
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Timepoint [4]
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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.
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Primary outcome [5]
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Number of Participants With SAEs With an Outcome of Death During the Open-label Period
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Assessment method [5]
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Any untoward medical occurrence (SAE) that resulted in death
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Timepoint [5]
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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.
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Primary outcome [6]
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Incidence Rates of Autoimmune Disorders in ABA-Treated Participants
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Assessment method [6]
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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.
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Timepoint [6]
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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).
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Primary outcome [7]
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Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants
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Assessment method [7]
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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.
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Timepoint [7]
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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).
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Primary outcome [8]
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Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants
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Assessment method [8]
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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.
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Timepoint [8]
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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).
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Primary outcome [9]
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Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period
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Assessment method [9]
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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.
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Timepoint [9]
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Open-Label Period (Month 12 to Month 24)
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Primary outcome [10]
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Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
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Assessment method [10]
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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.
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Timepoint [10]
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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.
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Primary outcome [11]
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Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
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Assessment method [11]
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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
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Timepoint [11]
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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.
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Secondary outcome [1]
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Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12
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Assessment method [1]
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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].
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Timepoint [1]
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Month 12
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Secondary outcome [2]
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Number of Participants With Major Clinical Response (MCR) at Month 12
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Assessment method [2]
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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]).
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Timepoint [2]
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Month 12
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Secondary outcome [3]
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Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Month 12
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Secondary outcome [4]
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Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12
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Assessment method [4]
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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.
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Timepoint [4]
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Month 12
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Secondary outcome [5]
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Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Month 12
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Secondary outcome [6]
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Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12
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Assessment method [6]
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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
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Timepoint [6]
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Baseline, Month 12
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Secondary outcome [7]
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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)
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Assessment method [7]
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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).
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Timepoint [7]
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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.
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Secondary outcome [8]
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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
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Assessment method [8]
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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).
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Timepoint [8]
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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.
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Secondary outcome [9]
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Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Month 24
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Secondary outcome [10]
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Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, Month 24
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Secondary outcome [11]
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Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, Month 24
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Secondary outcome [12]
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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
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Assessment method [12]
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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.
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Timepoint [12]
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Month 12, Month 24
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Secondary outcome [13]
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Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, Month 12, Month 24
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Secondary outcome [14]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period
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Assessment method [14]
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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.
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Timepoint [14]
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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.
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Secondary outcome [15]
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Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period
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Assessment method [15]
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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
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Timepoint [15]
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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.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2009
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Sample size
Target
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Accrual to date
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Final
1052
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Local Institution - Malvern
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Recruitment hospital [2]
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Local Institution - Shenton Park
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Recruitment postcode(s) [1]
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3144 - Malvern
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Recruitment postcode(s) [2]
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6008 - Shenton Park
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Alabama
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0
0
United States of America
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State/province [2]
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California
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Country [3]
0
0
United States of America
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State/province [3]
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Colorado
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0
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United States of America
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State/province [4]
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Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
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0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Maryland
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Nebraska
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Country [8]
0
0
United States of America
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State/province [8]
0
0
New York
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Country [9]
0
0
United States of America
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State/province [9]
0
0
North Carolina
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Oklahoma
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Pennsylvania
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Country [12]
0
0
United States of America
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State/province [12]
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0
South Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Texas
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Virginia
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Country [15]
0
0
Belgium
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State/province [15]
0
0
Antwerpen
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Country [16]
0
0
Belgium
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State/province [16]
0
0
Bruxelles
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Country [17]
0
0
Belgium
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State/province [17]
0
0
Hasselt
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Country [18]
0
0
Belgium
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State/province [18]
0
0
Leuven
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Goias
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Parana
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Rio De Janeiro
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Country [22]
0
0
Brazil
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State/province [22]
0
0
Rio Grande Do Sul
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Country [23]
0
0
Brazil
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State/province [23]
0
0
Sao Paulo
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Country [24]
0
0
Canada
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State/province [24]
0
0
Newfoundland and Labrador
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Country [25]
0
0
Canada
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State/province [25]
0
0
Ontario
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Country [26]
0
0
Canada
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State/province [26]
0
0
Quebec
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Country [27]
0
0
Canada
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State/province [27]
0
0
Saskatchewan
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Country [28]
0
0
Czech Republic
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State/province [28]
0
0
Prague 2
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France
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France
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Anyang
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Distrito Federal
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United Kingdom
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00122382
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00122382
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