An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

NCT01357668 | Active Not Recruiting

• 1 other identifier: IM101-240
• Study Type: observational
• Target: 800
• Locations: 25 countries
• Sites: 59

Brief Summary

The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

• Incidence rate of serious infections

  10 years

• Incidence rate of malignancies

  10 years

• Incidence rate of autoimmune disorders

  10 years

Secondary Outcomes (2)

• Number of serious adverse events

  10 years

• Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections)

  10 years

Study Arms (1)

Patients with JIA who are treated with Abatacept

Patients with JIA who are treated with Abatacept according to physicians'/families' decisions

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric rheumatology clinics

You may qualify if:

• Diagnosis of JIA (any subtype)
• Age \< 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept
• Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial
• Parent or legally acceptable representative willing to participate in the study and sign the informed consent

You may not qualify if:

• Pregnant or nursing female at the time of enrollment
• Prior malignancies if the patient has not been malignancy free for at least 5 years.
• Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study
• Known poor compliance with clinic visits (based on physician judgment).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (59)

Local Institution - 0060

Little Rock, Arkansas, 72202, United States

Location

Local Institution - 0001

Princeton, New Jersey, 08540, United States

Location

Local Institution - 0059

Cincinnati, Ohio, 45229, United States

Location

Local Institution - 0025

Bregenz, 0, Austria

Location

Local Institution - 0002

Innsbruck, A-6020, Austria

Location

Local Institution - 0032

Vienna, 1160, Austria

Location

Local Institution - 0010

Botucatu, São Paulo, 18618-970, Brazil

Location

Local Institution - 0026

Campinas, São Paulo, 13083-888, Brazil

Location

Local Institution - 0028

São Paulo, São Paulo, 04023-061, Brazil

Location

Local Institution - 0027

Rio de Janeiro, 22250-110, Brazil

Location

Local Institution - 0029

Calgary, Alberta, T3B 6A8, Canada

Location

Local Institution - 0011

Montreal, Quebec, H4A 3J1, Canada

Location

Local Institution - 0035

Aarhus, Central Jutland, 8200, Denmark

Location

Local Institution - 0012

Copenhagen, 2100, Denmark

Location

Local Institution - 0040

Clermont-Ferrand, Puy-de-Dôme, 63000, France

Location

Local Institution - 0005

Paris, 75743, France

Location

Local Institution - 0041

Toulouse, 31059, France

Location

Local Institution - 0003

Bad Bramstedt, 24576, Germany

Location

Local Institution - 0030

Berlin, 10117, Germany

Location

Local Institution - 0034

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0031

Hamburg, 22391, Germany

Location

Local Institution - 0033

Heidelberg, 69120, Germany

Location

Local Institution - 0016

Thessaloniki, 54642, Greece

Location

Local Institution - 0017

Budapest, H-1023, Hungary

Location

Local Institution - 0014

Jerusalem, 91031, Israel

Location

Local Institution - 0042

Florence, 50139, Italy

Location

Local Institution - 0015

Genova, 16147, Italy

Location

Local Institution - 0043

Naples, 80131, Italy

Location

Local Institution - 0045

Napoli, 80138, Italy

Location

Local Institution - 0044

Padua, 35128, Italy

Location

Local Institution - 0046

Trento, 38100, Italy

Location

Local Institution - 0018

Riga, LV-1007, Latvia

Location

Local Institution - 0006

Guadalajara, Jalisco, 44620, Mexico

Location

Local Institution - 0047

Rotterdam, 3015 CE, Netherlands

Location

Local Institution - 0019

Utrecht, 3584 EA, Netherlands

Location

Local Institution - 0048

Tromsø, 9019, Norway

Location

Local Institution - 0049

Trondheim, 7006, Norway

Location

Local Institution - 0007

Lima, 1, Peru

Location

Local Institution - 0050

Lima, LIMA 14, Peru

Location

Local Institution - 0020

Lisbon, 1600, Portugal

Location

Local Institution - 0023

Bayamón, PR 960, Puerto Rico

Location

Local Institution - 0056

Bayamón, PR 960, Puerto Rico

Location

Local Institution - 0021

Cluj-Napoca, 0, Romania

Location

Local Institution - 0051

Moscow, 115522, Russia

Location

Local Institution

Moscow, 119991, Russia

Location

Local Institution - 0053

Saint Petersburg, 194100, Russia

Location

Local Institution - 0052

Saratov, 410054, Russia

Location

Local Institution - 0055

Jeddah, 21159, Saudi Arabia

Location

Local Institution - 0024

Riyadh, 11426, Saudi Arabia

Location

Local Institution - 0022

Piešťany, 0, Slovakia

Location

Local Institution - 0009

Pretoria, Gauteng, 0002, South Africa

Location

Local Institution - 0057

Panorama, Cape Town, Western Cape, 7500, South Africa

Location

Local Institution - 0058

Pretoria, 0084, South Africa

Location

Local Institution - 0036

Sant Joan Despí, Barcelona, 08970, Spain

Location

Local Institution - 0004

Barcelona, 08035, Spain

Location

Local Institution - 0038

Madrid, 28046, Spain

Location

Local Institution - 0037

Murcia, 30120, Spain

Location

Local Institution - 0039

Valencia, 46009, Spain

Location

Local Institution - 0013

Bristol, BS2 8BJ, United Kingdom

Location

Related Publications (1)

• Lovell DJ, Tzaribachev N, Henrickson M, Simonini G, Griffin TA, Alexeeva E, Bohnsack JF, Zeft A, Horneff G, Vehe RK, Stanevica V, Tarvin S, Trachana M, Del Rio AQ, Huber AM, Kietz D, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Simon TA, Martini A, Brunner HI, Ruperto N; for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG) section sign. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology (Oxford). 2024 Sep 1;63(SI2):SI195-SI206. doi: 10.1093/rheumatology/keae025.

  PMID: 38243722 DERIVED

Related Links

• BMS Clinical Trial Information

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: January 30, 2013
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): January 2, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

RO (1); IT (6); LA (1); ME (1); NL (2); US (3); NO (2); ES (5); DE (5); GR (1); CA (2); BR (4); IL (1); SL (1); HU (1); ZA (3); PE (2); GB (1); SA (2); FR (3); PT (1); PR (2); RU (4); DK (2); AU (3)