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)

NCT01844518 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: IM101-3012012-003195-39
• Study Type: interventional
• Target: 219
• Locations: 12 countries
• Sites: 57

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

Conditions

Active Polyarticular Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)

  Day 113

• Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose

  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

  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

  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

  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)

Study Arms (1)

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

Biological: Abatacept

Interventions

Abatacept BIOLOGICAL

Also known as: Orencia

Short and Long Terms: Orencia

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (57)

Local Institution - 0007

Birmingham, Alabama, 35233-1711, United States

Location

Local Institution - 0003

Little Rock, Arkansas, 72202, United States

Location

Local Institution - 0011

Hartford, Connecticut, 06106, United States

Location

Local Institution - 0009

Chicago, Illinois, 60637, United States

Location

Riley Hospital For Children

Indianapolis, Indiana, 46202, United States

Location

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Local Institution - 0001

Kansas City, Missouri, 64108, United States

Location

Local Institution - 0002

The Bronx, New York, 10467, United States

Location

Local Institution - 0008

Cincinnati, Ohio, 45229, United States

Location

Local Institution - 0005

Portland, Oregon, 97227, United States

Location

Local Institution - 0004

Salt Lake City, Utah, 84132, United States

Location

Seattle Children'S Hospital

Seattle, Washington, 98105, United States

Location

Local Institution - 0029

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution - 0028

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0030

Buenos Aires, 1270, Argentina

Location

Local Institution - 0064

CABA, 1427, Argentina

Location

Local Institution - 0031

Córdoba, 5000, Argentina

Location

Local Institution - 0037

Brussels, 1200, Belgium

Location

Local Institution - 0036

Ghent, 9000, Belgium

Location

Local Institution - 0049

Leuven, 3000, Belgium

Location

Local Institution

Curitiba, Paraná, 80250-060, Brazil

Location

Local Institution - 0038

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Local Institution - 0042

São Paulo, 04038-031, Brazil

Location

Local Institution - 0040

São Paulo, 05403-000, Brazil

Location

Local Institution - 0041

São Paulo, 05403-000, Brazil

Location

Local Institution - 0018

Bron, 69677, France

Location

Local Institution - 0016

Le Kremlin-Bicêtre, 94275, France

Location

Local Institution - 0014

Paris, 75743, France

Location

Local Institution - 0017

Poitiers, 86021, France

Location

Local Institution - 0015

Strasbourg, 67098, France

Location

Local Institution - 0044

Bad Bramstedt, 24576, Germany

Location

Local Institution - 0045

Berlin, 13353, Germany

Location

Local Institution - 0046

Hamburg, 22081, Germany

Location

Local Institution - 0048

Heidelberg, 69120, Germany

Location

Local Institution - 0047

Sankt Augustin, 53757, Germany

Location

Local Institution - 0061

Florence, 50139, Italy

Location

Local Institution

Genova, 16147, Italy

Location

Local Institution - 0022

Milan, 20122, Italy

Location

Local Institution - 0062

Napoli, 80131, Italy

Location

Local Institution - 0060

Guadalajara, Jalisco, 44620, Mexico

Location

Local Institution - 0059

Mexico City, Mexico City, 06720, Mexico

Location

Local Institution - 0057

Mexico City, Mexico City, 06726, Mexico

Location

Local Institution - 0056

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0058

Mérida, Yucatán, 97133, Mexico

Location

Local Institution - 0027

Lima, 11, Peru

Location

Local Institution

Lima, 11, Peru

Location

Local Institution - 0025

Lima, 27, Peru

Location

Local Institution - 0026

Lima, 5, Peru

Location

Local Institution - 0068

Tolyatti, 445039, Russia

Location

Local Institution - 0035

Park West, Bloemfontein, Free State, 9301, South Africa

Location

Local Institution - 0032

Pretoria, Gauteng, 0002, South Africa

Location

Local Institution - 0034

Pretoria, Gauteng, 0084, South Africa

Location

Local Institution - 0033

Cape Town, Western Cape, 7500, South Africa

Location

Local Institution - 0050

Barcelona, 08950, Spain

Location

Local Institution - 0053

Madrid, 28034, Spain

Location

Local Institution - 0055

Madrid, 28041, Spain

Location

Local Institution - 0052

Valencia, 46026, Spain

Location

Related Publications (6)

• 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.

  PMID: 37453737 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.

  PMID: 37221146 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.

  PMID: 36710243 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.

  PMID: 33452173 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.

  PMID: 32087715 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.

  PMID: 29481737 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: August 30, 2013
• Primary Completion: March 12, 2015
• Study Completion: February 1, 2023
• Last Updated: July 12, 2023
• Results First Posted: March 24, 2016

Record last verified: 2023-06

Locations

BR (5); DE (5); PE (4); US (12); ES (4); ME (5); BE (3); FR (5); RU (1); ZA (4); IT (4); AR (5)