Back to resultsPharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Primary Purpose
Active Polyarticular Juvenile Idiopathic Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept
Sponsored by
About this trial
This is an interventional treatment trial for Active Polyarticular Juvenile Idiopathic Arthritis
Eligibility Criteria
Inclusion Criteria:
- JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening
- Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population
- Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.
Exclusion Criteria:
- Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.
- Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
- Subjects who have failed more than two TNFα antagonists or other biologic DMARDs
Sites / Locations
- Local Institution - 0007
- Local Institution - 0003
- Local Institution - 0011
- Local Institution - 0009
- Riley Hospital For Children
- University Of Kansas Medical Center
- Local Institution - 0001
- Local Institution - 0002
- Local Institution - 0008
- Local Institution - 0005
- Local Institution - 0004
- Seattle Children'S Hospital
- Local Institution - 0029
- Local Institution - 0028
- Local Institution - 0030
- Local Institution - 0064
- Local Institution - 0031
- Local Institution - 0037
- Local Institution - 0036
- Local Institution - 0049
- Local Institution
- Local Institution - 0038
- Local Institution - 0042
- Local Institution - 0040
- Local Institution - 0041
- Local Institution - 0018
- Local Institution - 0016
- Local Institution - 0014
- Local Institution - 0017
- Local Institution - 0015
- Local Institution - 0044
- Local Institution - 0045
- Local Institution - 0046
- Local Institution - 0048
- Local Institution - 0047
- Local Institution - 0061
- Local Institution
- Local Institution - 0022
- Local Institution - 0062
- Local Institution - 0057
- Local Institution - 0059
- Local Institution - 0060
- Local Institution - 0056
- Local Institution - 0058
- Local Institution - 0027
- Local Institution
- Local Institution - 0025
- Local Institution - 0026
- Local Institution - 0068
- Local Institution - 0035
- Local Institution - 0032
- Local Institution - 0034
- Local Institution - 0033
- Local Institution - 0050
- Local Institution - 0053
- Local Institution - 0055
- Local Institution - 0052
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Short and Long Terms: Orencia
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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:
number of active joints
number of joints with limitation of motion (LOM)
physician global assessment of disease activity
parent global assessment of patient overall well-being
functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ)
C-reactive protein (CRP). In addition to the above condition, to be considered a responder participants cannot have ≥30% worsening in more than 1 of the 3 remaining JIA core set variables for which improvement was not observed.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01844518
Brief Title
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Official Title
A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2013 (Actual)
Primary Completion Date
March 12, 2015 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Polyarticular Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short and Long Terms: Orencia
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Primary Outcome Measure Information:
Title
Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17
Description
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.
Time Frame
Day 113
Secondary Outcome Measure Information:
Title
Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)
Description
ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables:
number of active joints
number of joints with limitation of motion (LOM)
physician global assessment of disease activity
parent global assessment of patient overall well-being
functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ)
C-reactive protein (CRP). In addition to the above condition, to be considered a responder participants cannot have ≥30% worsening in more than 1 of the 3 remaining JIA core set variables for which improvement was not observed.
Time Frame
Day 113
Title
Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose
Description
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.
Time Frame
Days 57, 85 and 113
Title
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
Description
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.
Time Frame
From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period)
Title
Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period
Description
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.
Time Frame
From first dose up to 56 days after last dose ( up to approximately 2 years)
Title
Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort
Description
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.
Time Frame
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)
Title
Number of Participants With Positive Immunogenicity Response in the Cumulative Period
Description
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.
Time Frame
From first dose up to 6 months following treatment discontinuation (up to approximately 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening
Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population
Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.
Exclusion Criteria:
Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.
Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
Subjects who have failed more than two TNFα antagonists or other biologic DMARDs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0007
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1711
Country
United States
Facility Name
Local Institution - 0003
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Local Institution - 0011
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Local Institution - 0009
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Local Institution - 0001
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Local Institution - 0002
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Local Institution - 0008
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Local Institution - 0005
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Local Institution - 0004
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Seattle Children'S Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Local Institution - 0029
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution - 0028
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution - 0030
City
Buenos Aires
ZIP/Postal Code
1270
Country
Argentina
Facility Name
Local Institution - 0064
City
Caba
ZIP/Postal Code
1427
Country
Argentina
Facility Name
Local Institution - 0031
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0037
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 0036
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0049
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Local Institution - 0038
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution - 0042
City
Sao Paulo
ZIP/Postal Code
04038-031
Country
Brazil
Facility Name
Local Institution - 0040
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Local Institution - 0041
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Local Institution - 0018
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Local Institution - 0016
City
Le Kremlin Bicetre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
Local Institution - 0014
City
Paris Cedex 15
ZIP/Postal Code
75743
Country
France
Facility Name
Local Institution - 0017
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution - 0015
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Local Institution - 0044
City
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
Facility Name
Local Institution - 0045
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution - 0046
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Local Institution - 0048
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 0047
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Facility Name
Local Institution - 0061
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Local Institution - 0022
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution - 0062
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0057
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution - 0059
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution - 0060
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Local Institution - 0056
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution - 0058
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97133
Country
Mexico
Facility Name
Local Institution - 0027
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Local Institution - 0025
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Local Institution - 0026
City
Lima
ZIP/Postal Code
5
Country
Peru
Facility Name
Local Institution - 0068
City
Tolyatti
ZIP/Postal Code
445039
Country
Russian Federation
Facility Name
Local Institution - 0035
City
Park West, Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Local Institution - 0032
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Local Institution - 0034
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Local Institution - 0033
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution - 0050
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Local Institution - 0053
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0055
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0052
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33452173
Citation
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.
Results Reference
derived
PubMed Identifier
32087715
Citation
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.
Results Reference
derived
PubMed Identifier
29481737
Citation
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
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