BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

NCT00095173 | Completed Phase 3 Results

• 1 other identifier: IM101-033
• Study Type: interventional
• Target: 214
• Locations: 11 countries
• Sites: 36

Brief Summary

The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

Conditions

Juvenile Rheumatoid Arthritis

Keywords

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)

  Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed. All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)

  Period B (Day 113 to Day 282)

Secondary Outcomes (14)

• Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)

  Period B (Day 113 to Day 282)

• Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)

  Period A (Day 1 to Day 113)

• Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)

  Period B (Day 113 to Day 282)

• Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)

  Period C (Day 282 to end of study)

• Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)

  Period B (Day 113 to Day 282)

Study Arms (3)

Abatacept

ACTIVE COMPARATOR

Double Blind Period

Drug: Abatacept

Placebo

PLACEBO COMPARATOR

Double Blind Period

Drug: Placebo

Abatacept - Open Label

EXPERIMENTAL

Drug: Abatacept

Interventions

Abatacept DRUG

IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).

Also known as: Orencia

Abatacept

Placebo DRUG

IV infusions, IV, N/A, every 4 weeks, 6 months.

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis;
• Current active arthritis;
• Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD);
• Subjects must discontinue use of any DMARD other than methotrexate prior to the first dose of study medication

You may not qualify if:

• Presence of infection or history of frequent acute or chronic infections;
• Joint replacement surgery required during the study or history of surgery on more than 5 joints;
• Live vaccines within 3 months of the first dose of study medication;
• Unresolved serious bacterial infection or chronic bacterial infection;
• Subjects who currently have intermittent fever due to JRA/JIA, rheumatoid rash, hepato-splenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (36)

Unknown Facility

Omaha, Nebraska, United States

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Livingston, New Jersey, United States

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New Hyde Park, New York, United States

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Valhalla, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Duncansville, Pennsylvania, United States

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Dallas, Texas, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Bregenz, Austria

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Botucatu, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Paris, France

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Strasbourg, France

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Berlin, Germany

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Bremen, Germany

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Halle, Germany

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Hamburg, Germany

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Florence, Italy

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Genova, Italy

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Milan, Italy

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Napoli, Italy

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Roma, Italy

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Trieste, Italy

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Guadalajara, Mexico

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Mexico City, Mexico

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Monterrey, Mexico

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Puebla City, Mexico

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San Luis Potosí City, Mexico

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Lima, Peru

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Lisbon, Portugal

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A Coruña, Spain

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Valencia, Spain

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Lausanne, Switzerland

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Related Publications (8)

• 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

• Lim LSH, Lokku A, Pullenayegum E, Ringold S. Probability of Response in the First Sixteen Weeks After Starting Biologics: An Analysis of Juvenile Idiopathic Arthritis Biologics Trials. Arthritis Care Res (Hoboken). 2023 Jun;75(6):1238-1249. doi: 10.1002/acr.25003. Epub 2023 Jan 18.

  PMID: 36651601 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

• Lovell DJ, Ruperto N, Mouy R, Paz E, Rubio-Perez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Huppertz HI, Job Deslandre C, Minden K, Punaro M, Block AJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Arthritis Rheumatol. 2015 Oct;67(10):2759-70. doi: 10.1002/art.39234.

  PMID: 26097215 DERIVED

• Ruperto N, Lovell DJ, Li T, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Alcala JO, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace C, Alessio M, Quartier P, Cortis E, Eberhard A, Simonini G, Lemelle I, Chalom EC, Sigal LH, Block A, Covucci A, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1542-51. doi: 10.1002/acr.20283. Epub 2010 Jul 1.

  PMID: 20597110 DERIVED

• Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Perez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Horneff G, Huppertz HI, Job-Deslandre C, Loy A, Minden K, Punaro M, Nunez AF, Sigal LH, Block AJ, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010 Jun;62(6):1792-802. doi: 10.1002/art.27431.

  PMID: 20191582 DERIVED

• Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Perez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Orozco J, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace CA, Sigal LH, Block AJ, Covucci A, Martini A, Giannini EH; Paediatric Rheumatology INternational Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008 Aug 2;372(9636):383-91. doi: 10.1016/S0140-6736(08)60998-8. Epub 2008 Jul 14.

  PMID: 18632147 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2004
• First Posted: November 2, 2004
• Study Start: December 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: November 1, 2011
• Last Updated: January 18, 2017
• Results First Posted: January 18, 2017

Record last verified: 2016-11

Locations

US (10); FR (2); IT (6); ES (2); AU (1); CH (1); PT (1); PE (1); DE (4); ME (5); BR (3)