Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003195-39 | EudraCT Number |
Not provided
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The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short and Long Terms: Orencia | Experimental | Short Term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 4 months Long term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 20 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 | Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL. | Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30) | ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0007 | Birmingham | Alabama | 35233-1711 | United States | ||
| Local Institution - 0003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37453737 | Derived | Ruperto N, Lovell DJ, Berman A, Anton J, Viola DO, Lauwerys B, Rama ME, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Ally M, Rubio-Perez N, Gervais E, Van Zyl R, Wong R, Askelson M, Martini A, Brunner HI; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials. J Rheumatol. 2023 Nov;50(11):1471-1480. doi: 10.3899/jrheum.2022-1320. Epub 2023 Jul 15. | |
| 37221146 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
219 participants were treated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SC Abatacept Ages 6 to 17 | Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
| Day 113 |
| Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL). Here 'n' number analyzed signifies participants who were evaluable for each time point. | Days 57, 85 and 113 |
| Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which 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. | From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period) |
| Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which 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. | From first dose up to 56 days after last dose ( up to approximately 2 years) |
| Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort | Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the short term (ST) period (initial 4-month treatment period) or completed the ST study without continuing abatacept treatment. | From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term) |
| Number of Participants With Positive Immunogenicity Response in the Cumulative Period | Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the short term (ST) or long term (LT) period, elected not to enter the LT period, or completed both ST and LT periods. | From first dose up to 6 months following treatment discontinuation (up to approximately 2 years) |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Local Institution - 0011 | Hartford | Connecticut | 06106 | United States |
| Local Institution - 0009 | Chicago | Illinois | 60637 | United States |
| Riley Hospital For Children | Indianapolis | Indiana | 46202 | United States |
| University Of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Local Institution - 0001 | Kansas City | Missouri | 64108 | United States |
| Local Institution - 0002 | The Bronx | New York | 10467 | United States |
| Local Institution - 0008 | Cincinnati | Ohio | 45229 | United States |
| Local Institution - 0005 | Portland | Oregon | 97227 | United States |
| Local Institution - 0004 | Salt Lake City | Utah | 84132 | United States |
| Seattle Children'S Hospital | Seattle | Washington | 98105 | United States |
| Local Institution - 0029 | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution - 0028 | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Local Institution - 0030 | Buenos Aires | 1270 | Argentina |
| Local Institution - 0064 | CABA | 1427 | Argentina |
| Local Institution - 0031 | Córdoba | 5000 | Argentina |
| Local Institution - 0037 | Brussels | 1200 | Belgium |
| Local Institution - 0036 | Ghent | 9000 | Belgium |
| Local Institution - 0049 | Leuven | 3000 | Belgium |
| Local Institution | Curitiba | Paraná | 80250-060 | Brazil |
| Local Institution - 0038 | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Local Institution - 0042 | São Paulo | 04038-031 | Brazil |
| Local Institution - 0040 | São Paulo | 05403-000 | Brazil |
| Local Institution - 0041 | São Paulo | 05403-000 | Brazil |
| Local Institution - 0018 | Bron | 69677 | France |
| Local Institution - 0016 | Le Kremlin-Bicêtre | 94275 | France |
| Local Institution - 0014 | Paris | 75743 | France |
| Local Institution - 0017 | Poitiers | 86021 | France |
| Local Institution - 0015 | Strasbourg | 67098 | France |
| Local Institution - 0044 | Bad Bramstedt | 24576 | Germany |
| Local Institution - 0045 | Berlin | 13353 | Germany |
| Local Institution - 0046 | Hamburg | 22081 | Germany |
| Local Institution - 0048 | Heidelberg | 69120 | Germany |
| Local Institution - 0047 | Sankt Augustin | 53757 | Germany |
| Local Institution - 0061 | Florence | 50139 | Italy |
| Local Institution | Genova | 16147 | Italy |
| Local Institution - 0022 | Milan | 20122 | Italy |
| Local Institution - 0062 | Naples | 80131 | Italy |
| Local Institution - 0060 | Guadalajara | Jalisco | 44620 | Mexico |
| Local Institution - 0059 | Mexico City | Mexico City | 06720 | Mexico |
| Local Institution - 0057 | Mexico City | Mexico City | 06726 | Mexico |
| Local Institution - 0056 | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution - 0058 | Mérida | Yucatán | 97133 | Mexico |
| Local Institution - 0027 | Lima | 11 | Peru |
| Local Institution | Lima | 11 | Peru |
| Local Institution - 0025 | Lima | 27 | Peru |
| Local Institution - 0026 | Lima | 5 | Peru |
| Local Institution - 0068 | Tolyatti | 445039 | Russia |
| Local Institution - 0035 | Park West, Bloemfontein | Free State | 9301 | South Africa |
| Local Institution - 0032 | Pretoria | Gauteng | 0002 | South Africa |
| Local Institution - 0034 | Pretoria | Gauteng | 0084 | South Africa |
| Local Institution - 0033 | Cape Town | Western Cape | 7500 | South Africa |
| Local Institution - 0050 | Barcelona | 08950 | Spain |
| Local Institution - 0053 | Madrid | 28034 | Spain |
| Local Institution - 0055 | Madrid | 28041 | Spain |
| Local Institution - 0052 | Valencia | 46026 | Spain |
| Derived |
| Brunner HI, Tzaribachev N, Louw I, Calvo Penades I, Avila-Zapata F, Horneff G, Foeldvari I, Kingsbury DJ, Paz Gastanaga ME, Wouters C, Breedt J, Wong R, Askelson M, Zhuo J, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG) investigators. Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2259-2266. doi: 10.1002/acr.25156. Epub 2023 Jun 22. |
| 36710243 | Derived | Ruperto N, Lovell DJ, Berman A, Avila-Zapata F, Horneff G, Alessio M, Becker ML, Belot A, Burgos-Vargas R, Gamir ML, Goldenstein-Schainberg C, Scheibel IM, Terreri MT, Zemel L, Zhuo J, Askelson M, Wong R, Martini A, Brunner HI; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1804-1814. doi: 10.1002/acr.24989. Epub 2023 Jan 29. |
| 33452173 | Derived | Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15. |
| 32087715 | Derived | Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penades I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept. Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x. |
| 29481737 | Derived | Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Berman A, Calvo Penades I, Anton J, Avila-Zapata F, Cuttica R, Horneff G, Foeldvari I, Keltsev V, Kingsbury DJ, Viola DO, Joos R, Lauwerys B, Paz Gastanaga ME, Rama ME, Wouters C, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Miraval T, Ally MMTM, Rubio-Perez N, Solau Gervais E, van Zyl R, Li X, Nys M, Wong R, Banerjee S, Lovell DJ, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: Results From a Phase III Open-Label Study. Arthritis Rheumatol. 2018 Jul;70(7):1144-1154. doi: 10.1002/art.40466. Epub 2018 May 20. |
| BMS Clinical Trial Patient Recruiting | View source |
| SC Abatacept Ages 2 to 5 |
SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated population included all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SC Abatacept Ages 6 to 17 | Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). |
| BG001 | SC Abatacept Ages 2 to 5 | SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Race | Number | Participants |
| |||||||||||||||||
| Weight | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 | Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL. | All treated participants with available PK measurements. Endpoint pre-specified to only be collected for 6-17 year age group. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 113 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30) | ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables:
| All treated participants in the 6-17 Year Age-Group Cohort. Endpoint prespecified to only be collected for 6-17 year age group. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 113 |
|
| ||||||||||||||||||||||||||
| Secondary | Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose | Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL). Here 'n' number analyzed signifies participants who were evaluable for each time point. | All treated participants with available PK measurements in the 6-17 Year Age-Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Days 57, 85 and 113 |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which 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. | All treated participants in the short-term period in the 6-17 Year Age Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group. | Posted | Count of Participants | Participants | From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which 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. | All treated participants in the cumulative period | Posted | Count of Participants | Participants | From first dose up to 56 days after last dose ( up to approximately 2 years) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort | Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the short term (ST) period (initial 4-month treatment period) or completed the ST study without continuing abatacept treatment. | All treated participants in the short-term period with available immunogenicity measurements in the 6-17 Year Age-Group Cohort. Endpoint pre-specified to only be collected for 6-17 year age group. | Posted | Count of Participants | Participants | From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Immunogenicity Response in the Cumulative Period | Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the short term (ST) or long term (LT) period, elected not to enter the LT period, or completed both ST and LT periods. | All treated participants in the cumulative period with available immunogenicity measurements. | Posted | Count of Participants | Participants | From first dose up to 6 months following treatment discontinuation (up to approximately 2 years) |
|
Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 113 months). SAEs and Other AEs were assessed from first dose to 168 days after last dose of study therapy (assessed up to approximately 113 months).
Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SC Abatacept Ages 6 to 17 | Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (<) 25 kilogram (kg) (50 milligram [mg] in 0.4 milliliter [mL] PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). | 0 | 173 | 18 | 173 | 127 | 173 |
| EG001 | SC Abatacept Ages 2 to 5 | SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). | 0 | 46 | 6 | 46 | 44 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 25.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 25.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 25.1 | Systematic Assessment |
| |
| Joint hyperextension | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | 25.1 | Systematic Assessment |
| |
| Ovarian germ cell teratoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.1 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 25.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Scarlet fever | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 25.1 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
| Male |
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| White |
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| More than one race |
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| Other |
|
| 25 to 50 kg |
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| >=50 kg |
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| Units | Counts |
|---|---|
| Participants |
|
|
SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to < 25 kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
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| Participants |
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