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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Experimental | Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16 | American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied. | Week 16 (Day 113) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16 | ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician's global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter |
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Inclusion Criteria:
Subjects who have a history of an inadequate therapeutic response or intolerance in the opinion of the examining physician to at least one biologics or Methotrexate (MTX).
Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular Rheumatoid Factor (RF+), polyarticular (RF-), or systemic with a polyarticular-course.
Men and women, ages 4 to 17 years, inclusive at enrollment.
Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by:
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 | Oobu-shi | Aichi-ken | 4748710 | Japan | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31039807 | Derived | Hara R, Umebayashi H, Takei S, Okamoto N, Iwata N, Yamasaki Y, Nakagishi Y, Kizawa T, Kobayashi I, Imagawa T, Kinjo N, Amano N, Takahashi Y, Mori M, Itoh Y, Yokota S. Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study. Pediatr Rheumatol Online J. 2019 Apr 30;17(1):17. doi: 10.1186/s12969-019-0319-4. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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23 participants were enrolled and 20 participants were treated. Reason for non-treatment was that 3 participants no longer met study criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept | Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Short Term Treatment Period (to Week 16) |
|
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| Week 16 (Day 113) |
| Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16 | Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100. | Week 16 (Day 113) |
| Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first. | Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months |
| Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period | Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter | 9 time points up to Week 16 (Day 113) |
| Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period | Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter | 9 time points up to Week 16 (Day 113) |
| Number of Participants With Positive Immunogenicity During the Short Term Period | A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose. | Day 1 up to Week 16 (Day 113) |
| Sapporo |
| Hokkaido |
| 0048618 |
| Japan |
| Local Institution | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution | Kobe | Hyōgo | 6500047 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 8908520 | Japan |
| Local Institution | Yokohama | Kanagawa | 2328555 | Japan |
| Local Institution | Yokohama | Kanagawa | 2360004 | Japan |
| Local Institution | Sendai | Miyagi | 9893126 | Japan |
| Local Institution | Niigata | Niigata | 9518520 | Japan |
| Local Institution | Nakagami-gun | Okinawa | 9030215 | Japan |
| Local Institution | Takatsuki-shi | Osaka | 5698686 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138603 | Japan |
| Local Institution | Shinjuku-ku | Tokyo | 1620054 | Japan |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
| Long Term Treatment Period |
|
|
All Treated Participants: All participants who received at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study |
| 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 |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16 | American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied. | All Treated Participants: All participants who received at least one dose of study medication | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 (Day 113) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16 | ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician's global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter | All Treated Participants: All participants who received at least one dose of study medication | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 (Day 113) |
|
| ||||||||||||||||||||||||||
| Secondary | Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16 | Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100. | All Treated Participants: All participants who received at least one dose of study medication | Posted | Median | Inter-Quartile Range | percentage of improvement from baseline | Week 16 (Day 113) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first. | All Treated Participants: All participants who received at least one dose of study medication | Posted | Number | participants | Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months |
| ||||||||||||||||||||||||||||
| Secondary | Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period | Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter | Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively). | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 9 time points up to Week 16 (Day 113) |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period | Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter | Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively). | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 9 time points up to Week 16 (Day 113) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Immunogenicity During the Short Term Period | A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose. | Immunogenicity analysis population: All participants who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication | Posted | Number | participants | Day 1 up to Week 16 (Day 113) |
|
During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period
From September 2013 to July 2018 (approximately 61 months)
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 | IV ABATACEPT | 6 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ENTEROCOLITIS VIRAL | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| VIRAL TONSILLITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| JUVENILE IDIOPATHIC ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRY EYE | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ANGULAR CHEILITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| ENTEROCOLITIS VIRAL | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| VIRAL PHARYNGITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| INFLUENZA B VIRUS TEST POSITIVE | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| PURPURA | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
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 | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| 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
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