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)
NCT ID: NCT01844518
Last Updated: 2023-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
219 participants
INTERVENTIONAL
2013-08-30
2023-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Short and Long Terms: Orencia
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
Abatacept
Interventions
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Abatacept
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0007
Birmingham, Alabama, United States
Local Institution - 0003
Little Rock, Arkansas, United States
Local Institution - 0011
Hartford, Connecticut, United States
Local Institution - 0009
Chicago, Illinois, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
Local Institution - 0001
Kansas City, Missouri, United States
Local Institution - 0002
The Bronx, New York, United States
Local Institution - 0008
Cincinnati, Ohio, United States
Local Institution - 0005
Portland, Oregon, United States
Local Institution - 0004
Salt Lake City, Utah, United States
Seattle Children'S Hospital
Seattle, Washington, United States
Local Institution - 0029
Rosario, Santa Fe Province, Argentina
Local Institution - 0028
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0030
Buenos Aires, , Argentina
Local Institution - 0064
CABA, , Argentina
Local Institution - 0031
Córdoba, , Argentina
Local Institution - 0037
Brussels, , Belgium
Local Institution - 0036
Ghent, , Belgium
Local Institution - 0049
Leuven, , Belgium
Local Institution
Curitiba, Paraná, Brazil
Local Institution - 0038
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0042
São Paulo, , Brazil
Local Institution - 0040
São Paulo, , Brazil
Local Institution - 0041
São Paulo, , Brazil
Local Institution - 0018
Bron, , France
Local Institution - 0016
Le Kremlin-Bicêtre, , France
Local Institution - 0014
Paris, , France
Local Institution - 0017
Poitiers, , France
Local Institution - 0015
Strasbourg, , France
Local Institution - 0044
Bad Bramstedt, , Germany
Local Institution - 0045
Berlin, , Germany
Local Institution - 0046
Hamburg, , Germany
Local Institution - 0048
Heidelberg, , Germany
Local Institution - 0047
Sankt Augustin, , Germany
Local Institution - 0061
Florence, , Italy
Local Institution
Genova, , Italy
Local Institution - 0022
Milan, , Italy
Local Institution - 0062
Napoli, , Italy
Local Institution - 0060
Guadalajara, Jalisco, Mexico
Local Institution - 0059
Mexico City, Mexico City, Mexico
Local Institution - 0057
Mexico City, Mexico City, Mexico
Local Institution - 0056
Monterrey, Nuevo León, Mexico
Local Institution - 0058
Mérida, Yucatán, Mexico
Local Institution - 0027
Lima, , Peru
Local Institution
Lima, , Peru
Local Institution - 0025
Lima, , Peru
Local Institution - 0026
Lima, , Peru
Local Institution - 0068
Tolyatti, , Russia
Local Institution - 0035
Park West, Bloemfontein, Free State, South Africa
Local Institution - 0032
Pretoria, Gauteng, South Africa
Local Institution - 0034
Pretoria, Gauteng, South Africa
Local Institution - 0033
Cape Town, Western Cape, South Africa
Local Institution - 0050
Barcelona, , Spain
Local Institution - 0053
Madrid, , Spain
Local Institution - 0055
Madrid, , Spain
Local Institution - 0052
Valencia, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2012-003195-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM101-301
Identifier Type: -
Identifier Source: org_study_id
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