Juvenile Idiopathic Arthritis (JIA) Registry

Juvenile Idiopathic Arthritis Clinical Trial

— STRIVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783510
• Other study ID #: P10-262
• Status: Completed
• Start date: July 11, 2008
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 849
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• JIA
• Juvenile Idiopathic Arthritis

Intervention

Biological:
• adalimumab
As prescribed by treating physician

Drug:
• Methotrexate
As prescribed by treating physician

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Norway,  Portugal,  Puerto Rico,  Slovakia,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Serious Adverse Events (SAEs)	Collected as events occur during the registry and as part of prior clinical studies. Events are collected retrospectively for patients who dosed prior to enrollment in the registry and as part of the Health Care Provider (HCP) process.	Up to 10 years
Primary	Incidence of Adverse Events (AEs) of Interest	Collected as events occur during the registry and as part of prior clinical studies. Events are collected retrospectively for patients who dosed prior to enrollment in the registry and as part of the Health Care Provider (HCP) process.	Up to 10 years
Secondary	Pediatric American College of Rheumatology (PedACR) 50	Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.	Up to 10 years
Secondary	Pediatric American College of Rheumatology (PedACR) 70	Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.	Up to 10 years
Secondary	Pediatric American College of Rheumatology (PedACR) - 30	Effectiveness data will be analyzed as observed and will be summarized for All the Treated Patient Population.	Up to 10 years
Secondary	Child Health Questionnaire (CHQ-PF50)	The results will be summarized at each visit and will be used in exploratory analyses.	Assessed in months 1,3, 6 and every 6 months through Year 5
Secondary	Pediatric American College of Rheumatology (PedACR) 90	Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.	Up to 10 years
Secondary	Juvenile arthritis disease activity score (JADAS)	Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population. Is the total scores of four activity scales (Physician's Global Assessment of patient's disease, Parents' Global Assessment of patient's overall well-being, Number of active joints and Normalized erythrocyte sedimentation rate (ESR) if collected and available.	Assessed in months 1,3, 6 and every 6 months through Year 5
Secondary	Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ)	Effectiveness of therapy through clinical assessment.	Assessed in months 1,3, 6 and every 6 months through Year 5