Clinical trial NCT00783510: Juvenile Idiopathic Arthritis (JIA) Registry
Official title: A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) - STRIVE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
JIA
Keywords: JIA
Juvenile Idiopathic Arthritis
Juvenile Arthritis
Polyarticular JIA
Polyarticular-course JIA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 849
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA, (defined as arthritis affecting greater than 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA), prescribed and treated in a routine clinical setting either with Humira® (adalimumab), or MTX. Approximately 800 patients will be enrolled in the United States, EU countries, and Australia. Approximately 40 to 45 physicians will be included based on participation in prior AbbVie Humira sponsored clinical JIA studies.

Brief summary: This is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years from the enrollment date into one of the treatment arms.

Detailed description: This registry will assess the incidence and rate of Humira (monotherapy or combination therapy with MTX) or MTX observational and treatment-emergent SAEs, Adverse Events of Special Interest (AESI) and Pregnancy in patients diagnosed with moderately to severely active polyarticular or polyarticular-course JIA through Year 5. From Year 6 through Year 10 SAEs, a subset of AESI that includes congestive heart failure (CHF), malignancies, AEs at least possibly related to and/or leading to discontinuation of registry treatment and pregnancies will be collected. For JIA patients 2 to\< 4 years of age in countries with available local approval for this group of patients at the time of consent to the registry, emergent AESI, SAEs and pregnancy (at the age when a patient can become pregnant) will be collected for the full 10 years. The approved age range for HUMIRA in the U.S., European Union (EU) and in Australia is 4 years of age and older, and recent approval in EU for JIA patients 2 to \< 4 years of age.

Patients who discontinue from the registry before 10 years will be offered to participate in the direct to Health Care Provider follow-up process, as allowed by local regulations.

Eligibility criteria: Inclusion Criteria:

* For a patient enrolling into the HUMIRA® arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA (defined as arthritis affecting \>= 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA) who has been prescribed HUMIRA® therapy according to the local approved HUMIRA® product labeling and meets one of the following criteria:
* Enrolled patients are 4 to 17 years of age as per approved HUMIRA® product label with the addition of JIA patients 2 to \< 4 years of age in countries with available local approval for this group of patients at the time of consent to the registry.
* Newly initiated (within 24 months of registry entry) on HUMIRA® therapy and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy, and the physician can provide available source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy;
* Or is entering after participation (within 24 months of registry entry or, if longer, continuously treated at the same site) in an AbbVie Humira sponsored study, regardless of age or the number of joints with symptoms of JIA, and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide available source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy.
* For a patient enrolling into the MTX arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA (defined as arthritis affecting \>= 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA) who is prescribed MTX therapy alone or in combination with other disease modifying anti-rheumatic drugs (DMARDs) according to the local product labeling (initiated treatment within 24 months of registry entry) and has received continuous therapy and the physician can available provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy.
* Patients who were treated in the MTX arm of this registry and prematurely discontinued from the MTX arm due to being a non-responder, or became intolerant of MTX treatment or are in need of combination treatment with HUMIRA® therapy may be eligible to enroll into the HUMIRA® treatment arm if all ongoing AEs/SAEs have been resolved, and they meet inclusion criteria and can enroll within the registry enrollment period. In case of ongoing AEs/SAEs at the time of the treatment arm switch, the AbbVie Designated Physician should be contacted to assess the eligibility of patient to roll into Humira treatment arm.
* Parent or guardian has voluntarily signed and dated an informed consent/patient authorization form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) if applicable according to local law, after the nature of the registry has been explained and the patient's parent or legal guardian has had the opportunity to ask questions. Pediatric patients will be included in all discussions as per applicable local regulations in order to obtain verbal or written assent.

Exclusion Criteria:

* Patients should not be enrolled into the HUMIRA® or Methotrexate (MTX) arm if they cannot be prescribed and treated in accordance with the approved local HUMIRA® and/or with the local MTX product label
* Patients should not be enrolled into the HUMIRA® or MTX arm if they require on-going treatment with Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), Enbrel® (etanercept), and Remicade® (infliximab), or any other approved biologic agents or investigational agents.
* Patients should not be enrolled into the MTX arm if they have had prior treatment with any investigational agent or anti-rheumatic biologic therapy such as, but not limited to, Orencia® (abatacept), Enbrel® (etanercept), Remicade® (infliximab), Rituxan® (rituximab), or Actemra® (tocilizumab)

Primary outcomes:
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 10 years
measure: Incidence of Adverse Events (AEs) of Interest
timeFrame: Up to 10 years
Secondary outcomes:
measure: Pediatric American College of Rheumatology (PedACR) 50
timeFrame: Up to 10 years
measure: Pediatric American College of Rheumatology (PedACR) 70
timeFrame: Up to 10 years
measure: Pediatric American College of Rheumatology (PedACR) - 30
timeFrame: Up to 10 years
measure: Child Health Questionnaire (CHQ-PF50)
timeFrame: Assessed in months 1,3, 6 and every 6 months through Year 5
measure: Pediatric American College of Rheumatology (PedACR) 90
timeFrame: Up to 10 years
measure: Juvenile arthritis disease activity score (JADAS)
timeFrame: Assessed in months 1,3, 6 and every 6 months through Year 5
measure: Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ)
timeFrame: Assessed in months 1,3, 6 and every 6 months through Year 5
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 21023
state: Arizona
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research /ID# 40227
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital /ID# 23505
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles /ID# 24386
state: California
city: Washington
country: United States
facility: Children's National Medical Center /ID# 23506
state: District of Columbia
city: Delray Beach
country: United States
facility: Duplicate_Arthritis Associates South FL /ID# 17001
state: Florida
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 21981
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Group Rheum /ID# 46343
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University /ID# 11421
state: Indiana
city: Louisville
country: United States
facility: University of Louisville /ID# 23507
state: Kentucky
city: Ellicott City
country: United States
facility: Arthritis Care Spec. of MD /ID# 21961
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center /ID# 21965
state: Massachusetts
city: Omaha
country: United States
facility: Creighton Univ Med Ctr /ID# 11423
state: Nebraska
city: West Orange
country: United States
facility: St. Barnabas Ambulatory Care /ID# 21025
state: New Jersey
city: New Hyde Park
country: United States
facility: North Shore University Hospital /ID# 21022
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center /ID# 20967
state: New York
city: Valhalla
country: United States
facility: New York Medical College /ID# 21964
state: New York
city: Durham
country: United States
facility: Duke Cancer Center /ID# 22904
state: North Carolina
city: Bismarck
country: United States
facility: Bone Spine Sports/Medctr One /ID# 21962
state: North Dakota
city: Akron
country: United States
facility: Akron Children's Hospital /ID# 22907
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 14101
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital /ID# 21963
state: Ohio
city: Portland
country: United States
facility: Legacy Emanuel Medical Center /ID# 14102
state: Oregon
city: Philadelphia
country: United States
facility: St. Christopher's Hospital /ID# 24385
state: Pennsylvania
city: Kingsport
country: United States
facility: Arthritis Associates of Kingsport /ID# 44462
state: Tennessee
city: Memphis
country: United States
facility: Dr. Ramesh Gupta /ID# 45342
state: Tennessee
city: Round Rock
country: United States
facility: Scott & White Health Care /ID# 36762
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah /ID# 21041
state: Utah
city: Burlington
country: United States
facility: Children's Speciality Center /ID# 11503
state: Vermont
city: Seattle
country: United States
facility: Seattle Children's Hospital /ID# 20968
state: Washington
city: Milwaukee
country: United States
facility: Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226
state: Wisconsin
city: Adelaide
country: Australia
facility: Duplicate_Womens and Childrens Hospital /ID# 59182
state: South Australia
city: Linz
country: Austria
facility: Duplicate_Kepler Universitaetsklinikum GmbH /ID# 39068
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 26126
state: Steiermark
city: Bregenz
country: Austria
facility: Landeskrankenhaus Bregenz /ID# 26128
state: Vorarlberg
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 26127
state: Wien
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno /ID# 37343
city: Praha
country: Czechia
facility: Revmatologicky ustav v Praze /ID# 43344
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 47401
city: Praha
country: Czechia
facility: Fakultni Nemocnice v Motole /ID# 37342
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital /ID# 25445
state: Midtjylland
city: Copenhagen
country: Denmark
facility: Duplicate_Rigshospitalet, Finsen Centre /ID# 25444
city: Strasbourg
country: France
facility: CHU Strasbourg - Hopital de Hautepierre /ID# 25450
state: Bas-Rhin
city: Bordeaux
country: France
facility: Duplicate_CHU Bordeaux - Hopital Pellegrin /ID# 25454
state: Gironde
city: Tours CEDEX 9
country: France
facility: CHRU Tours - Hopital Bretonneau /ID# 27126
state: Indre-et-Loire
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Hopitaux de Brabois /ID# 25452
state: Meurthe-et-Moselle
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 25449
state: Nord
city: Toulouse
country: France
facility: CHU Toulouse /ID# 37347
state: Occitanie
city: Le Kremlin Bicetre
country: France
facility: AP-HP - Hôpital Bicêtre /ID# 25443
city: Paris
country: France
facility: Duplicate_AP-HP - Hopital Cochin /ID# 37345
city: Paris
country: France
facility: AP-HP - Hopital Necker /ID# 25442
city: Rennes
country: France
facility: Duplicate_CHU de Rennes - Hospital Sud /ID# 27123
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen /ID# 39070
state: Baden-Wuerttemberg
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch /ID# 37348
city: Bremen
country: Germany
facility: Klinikum Bremen Mitte /ID# 45942
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH /ID# 44003
city: Garmisch-Patenkirchen
country: Germany
facility: Center Rheumatology Child&Adol /ID# 39069
city: Hamburg
country: Germany
facility: Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH /ID# 37349
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin /ID# 41622
city: Wedel
country: Germany
facility: Rheumazentrum Wedel /ID# 37350
city: Athens
country: Greece
facility: Children's Hosp P. A. Kyriakou /ID# 25448
state: Attiki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 25447
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 95863
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer /ID# 26123
state: Firenze
city: Rome
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074
state: Roma
city: Brescia
country: Italy
facility: Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077
city: Catania
country: Italy
facility: Duplicate_Universita di Catania /ID# 39075
city: Chieti
country: Italy
facility: Ospedale Ss. Annunziata /ID# 37353
city: Genova
country: Italy
facility: Istituto Giannina Gaslini /ID# 26668
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124
city: Naples
country: Italy
facility: Duplicate_Universita di Napoli Federico II /ID# 39078
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 39072
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico /ID# 39076
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 48842
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Radiumhospitalet /ID# 46402
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE /ID# 37355
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081
city: Bayamon
country: Puerto Rico
facility: Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047
city: Bayamon
country: Puerto Rico
facility: Puerto Rico Children Hospital /ID# 47742
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob /ID# 38102
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 37358
state: Barcelona
city: Leganes
country: Spain
facility: Hospital Universitario Severo Ochoa /ID# 41751
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 37357
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus /ID# 37360
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 41624
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 37359
city: Gothenburg
country: Sweden
facility: Queen Silvia Children's Hosp /ID# 26125
state: Vastra Gotalands Lan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: