Clinical trial NCT01357668: An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
Official title: An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 800
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric rheumatology clinics

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.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Incidence rate of serious infections
timeFrame: 10 years
measure: Incidence rate of malignancies
timeFrame: 10 years
measure: Incidence rate of autoimmune disorders
timeFrame: 10 years
Secondary outcomes:
measure: Number of serious adverse events
timeFrame: 10 years
measure: Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections)
timeFrame: 10 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Local Institution - 0060
state: Arkansas
city: Princeton
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Cincinnati
country: United States
facility: Local Institution - 0059
state: Ohio
city: Bregenz
country: Austria
facility: Local Institution - 0025
city: Innsbruck
country: Austria
facility: Local Institution - 0002
city: Vienna
country: Austria
facility: Local Institution - 0032
city: Botucatu
country: Brazil
facility: Local Institution - 0010
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 0028
state: SAO Paulo
city: Campinas
country: Brazil
facility: Local Institution - 0026
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution - 0027
city: Calgary
country: Canada
facility: Local Institution - 0029
state: Alberta
city: Montreal
country: Canada
facility: Local Institution - 0011
state: Quebec
city: Aarhus
country: Denmark
facility: Local Institution - 0035
state: Midtjylland
city: Copenhagen
country: Denmark
facility: Local Institution - 0012
city: Clermont-ferrand
country: France
facility: Local Institution - 0040
state: Puy-de-Dôme
city: Paris Cedex 15
country: France
facility: Local Institution - 0005
city: Toulouse cedex 9
country: France
facility: Local Institution - 0041
city: Bad Bramstedt
country: Germany
facility: Local Institution - 0003
city: Berlin
country: Germany
facility: Local Institution - 0030
city: Freiburg
country: Germany
facility: Local Institution - 0034
city: Hamburg
country: Germany
facility: Local Institution - 0031
city: Heidelberg
country: Germany
facility: Local Institution - 0033
city: Thessaloniki
country: Greece
facility: Local Institution - 0016
city: Budapest
country: Hungary
facility: Local Institution - 0017
city: Jerusalem
country: Israel
facility: Local Institution - 0014
city: Firenze
country: Italy
facility: Local Institution - 0042
city: Genova
country: Italy
facility: Local Institution - 0015
city: Naples
country: Italy
facility: Local Institution - 0043
city: Napoli
country: Italy
facility: Local Institution - 0045
city: Padova
country: Italy
facility: Local Institution - 0044
city: Trento
country: Italy
facility: Local Institution - 0046
city: Riga
country: Latvia
facility: Local Institution - 0018
city: Guadalajara
country: Mexico
facility: Local Institution - 0006
state: Jalisco
city: Rotterdam
country: Netherlands
facility: Local Institution - 0047
city: Utrecht
country: Netherlands
facility: Local Institution - 0019
city: Tromso
country: Norway
facility: Local Institution - 0048
city: Trondheim
country: Norway
facility: Local Institution - 0049
city: Lima
country: Peru
facility: Local Institution - 0007
city: Lima
country: Peru
facility: Local Institution - 0050
city: Lisboa
country: Portugal
facility: Local Institution - 0020
city: Bayamon
country: Puerto Rico
facility: Local Institution - 0023
city: Bayamon
country: Puerto Rico
facility: Local Institution - 0056
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0021
city: Moscow
country: Russian Federation
facility: Local Institution - 0051
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0053
city: Saratov
country: Russian Federation
facility: Local Institution - 0052
city: Jeddah
country: Saudi Arabia
facility: Local Institution - 0055
city: Riyadh 11426
country: Saudi Arabia
facility: Local Institution - 0024
city: Piestany
country: Slovakia
facility: Local Institution - 0022
city: Pretoria
country: South Africa
facility: Local Institution - 0009
state: Gauteng
city: Panorama, Cape Town
country: South Africa
facility: Local Institution - 0057
state: Western CAPE
city: Pretoria
country: South Africa
facility: Local Institution - 0058
city: Sant Joan Despí
country: Spain
facility: Local Institution - 0036
state: Barcelona
city: Barcelona
country: Spain
facility: Local Institution - 0004
city: Madrid
country: Spain
facility: Local Institution - 0038
city: Murcia
country: Spain
facility: Local Institution - 0037
city: Valencia
country: Spain
facility: Local Institution - 0039
city: Bristol
country: United Kingdom
facility: Local Institution - 0013
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: