Juvenile Idiopathic Arthritis (JIA) Registry
- Conditions
- Juvenile Idiopathic ArthritisJIA
- Interventions
- Registration Number
- NCT00783510
- Lead Sponsor
- AbbVie
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 849
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HUMIRA® Treatment Arm adalimumab For patients taking HUMIRA® Methotrexate Treatment Arm Methotrexate For patients taking Methotrexate
- Primary Outcome Measures
Name Time Method Incidence of Serious Adverse Events (SAEs) Up to 10 years 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.
Incidence of Adverse Events (AEs) of Interest Up to 10 years 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.
- Secondary Outcome Measures
Name Time Method Pediatric American College of Rheumatology (PedACR) 90 Up to 10 years Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Juvenile arthritis disease activity score (JADAS) Assessed in months 1,3, 6 and every 6 months through Year 5 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.
Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ) Assessed in months 1,3, 6 and every 6 months through Year 5 Effectiveness of therapy through clinical assessment.
Pediatric American College of Rheumatology (PedACR) 70 Up to 10 years Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Pediatric American College of Rheumatology (PedACR) - 30 Up to 10 years Effectiveness data will be analyzed as observed and will be summarized for All the Treated Patient Population.
Child Health Questionnaire (CHQ-PF50) Assessed in months 1,3, 6 and every 6 months through Year 5 The results will be summarized at each visit and will be used in exploratory analyses.
Pediatric American College of Rheumatology (PedACR) 50 Up to 10 years Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Trial Locations
- Locations (92)
University of Louisville /ID# 23507
🇺🇸Louisville, Kentucky, United States
Arthritis Care Spec. of MD /ID# 21961
🇺🇸Ellicott City, Maryland, United States
North Shore University Hospital /ID# 21022
🇺🇸New Hyde Park, New York, United States
University of Rochester Medical Center /ID# 20967
🇺🇸Rochester, New York, United States
Ospedale Ss. Annunziata /ID# 37353
🇮🇹Chieti, Italy
Akron Children's Hospital /ID# 22907
🇺🇸Akron, Ohio, United States
Hospital Universitario Ramon y Cajal /ID# 41624
🇪🇸Madrid, Spain
Hospital Universitario y Politecnico La Fe /ID# 37359
🇪🇸Valencia, Spain
Hospital Universitario Vall d'Hebron /ID# 37357
🇪🇸Barcelona, Spain
Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226
🇺🇸Milwaukee, Wisconsin, United States
Duplicate_Kepler Universitaetsklinikum GmbH /ID# 39068
🇦🇹Linz, Oberoesterreich, Austria
Klinikum Dortmund gGmbH /ID# 44003
🇩🇪Dortmund, Germany
Duplicate_AP-HP - Hopital Cochin /ID# 37345
🇫🇷Paris, France
Revmatologicky ustav v Praze /ID# 43344
🇨🇿Praha, Czechia
Universitaetsklinikum Tuebingen /ID# 39070
🇩🇪Tubingen, Baden-Wuerttemberg, Germany
Klinikum St. Georg gGmbH /ID# 37349
🇩🇪Leipzig, Germany
Children's National Medical Center /ID# 23506
🇺🇸Washington, District of Columbia, United States
CHRU Nancy - Hopitaux de Brabois /ID# 25452
🇫🇷Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France
Helios Klinikum Berlin-Buch /ID# 37348
🇩🇪Berlin, Germany
Duplicate_Universita di Catania /ID# 39075
🇮🇹Catania, Italy
AP-HP - Hôpital Bicêtre /ID# 25443
🇫🇷Le Kremlin Bicetre, France
Center Rheumatology Child&Adol /ID# 39069
🇩🇪Garmisch-Patenkirchen, Germany
Rheumazentrum Wedel /ID# 37350
🇩🇪Wedel, Germany
Fakultni Nemocnice Brno /ID# 37343
🇨🇿Brno, Czechia
Hospital Universitario Severo Ochoa /ID# 41751
🇪🇸Leganes, Madrid, Spain
Vseobecna fakultni nemocnice v Praze /ID# 47401
🇨🇿Praha, Czechia
Fakultni Nemocnice v Motole /ID# 37342
🇨🇿Praha, Czechia
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623
🇩🇪Berlin, Germany
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223
🇩🇪Hamburg, Germany
Klinikum Bremen Mitte /ID# 45942
🇩🇪Bremen, Germany
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966
🇺🇸Chicago, Illinois, United States
Nationwide Children's Hospital /ID# 21963
🇺🇸Columbus, Ohio, United States
Tufts Medical Center /ID# 21965
🇺🇸Boston, Massachusetts, United States
Children's Hospital Los Angeles /ID# 24386
🇺🇸Los Angeles, California, United States
Duplicate_Arthritis Associates South FL /ID# 17001
🇺🇸Delray Beach, Florida, United States
The University of Chicago Medical Center /ID# 21981
🇺🇸Chicago, Illinois, United States
Methodist Medical Group Rheum /ID# 46343
🇺🇸Peoria, Illinois, United States
New York Medical College /ID# 21964
🇺🇸Valhalla, New York, United States
Scott & White Health Care /ID# 36762
🇺🇸Round Rock, Texas, United States
Seattle Children's Hospital /ID# 20968
🇺🇸Seattle, Washington, United States
Duplicate_Womens and Childrens Hospital /ID# 59182
🇦🇺Adelaide, South Australia, Australia
Duplicate_CHU de Rennes - Hospital Sud /ID# 27123
🇫🇷Rennes, France
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095
🇭🇺Budapest, Hungary
Children's Hosp P. A. Kyriakou /ID# 25448
🇬🇷Athens, Attiki, Greece
Hospital Infantil Universitario Nino Jesus /ID# 37360
🇪🇸Madrid, Spain
Indiana University /ID# 11421
🇺🇸Indianapolis, Indiana, United States
University of Cincinnati /ID# 14101
🇺🇸Cincinnati, Ohio, United States
Duke Cancer Center /ID# 22904
🇺🇸Durham, North Carolina, United States
Bone Spine Sports/Medctr One /ID# 21962
🇺🇸Bismarck, North Dakota, United States
Duplicate_Rigshospitalet, Finsen Centre /ID# 25444
🇩🇰Copenhagen, Denmark
Aarhus University Hospital /ID# 25445
🇩🇰Aarhus N, Midtjylland, Denmark
Legacy Emanuel Medical Center /ID# 14102
🇺🇸Portland, Oregon, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 21023
🇺🇸Phoenix, Arizona, United States
University of Utah /ID# 21041
🇺🇸Salt Lake City, Utah, United States
CHU Strasbourg - Hopital de Hautepierre /ID# 25450
🇫🇷Strasbourg, Bas-Rhin, France
General Hospital of Thessaloniki Hippokrateio /ID# 25447
🇬🇷Thessaloniki, Greece
Hospital Garcia de Orta, EPE /ID# 37355
🇵🇹Almada, Portugal
Narodny ustav reumatickych chorob /ID# 38102
🇸🇰Piestany, Slovakia
Arkansas Children's Hospital /ID# 23505
🇺🇸Little Rock, Arkansas, United States
Duplicate_CHU Bordeaux - Hopital Pellegrin /ID# 25454
🇫🇷Bordeaux, Gironde, France
Landeskrankenhaus Bregenz /ID# 26128
🇦🇹Bregenz, Vorarlberg, Austria
Catalina Pointe Clinical Research /ID# 40227
🇺🇸Tucson, Arizona, United States
Creighton Univ Med Ctr /ID# 11423
🇺🇸Omaha, Nebraska, United States
Medizinische Universitaet Wien /ID# 26127
🇦🇹Vienna, Wien, Austria
Debreceni Egyetem Klinikai Kozpont /ID# 95863
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Universitair Medisch Centrum Utrecht /ID# 48842
🇳🇱Utrecht, Netherlands
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047
🇵🇷Bayamon, Puerto Rico
Arthritis Associates of Kingsport /ID# 44462
🇺🇸Kingsport, Tennessee, United States
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081
🇵🇹Porto, Portugal
St. Barnabas Ambulatory Care /ID# 21025
🇺🇸West Orange, New Jersey, United States
Dr. Ramesh Gupta /ID# 45342
🇺🇸Memphis, Tennessee, United States
CHU Toulouse /ID# 37347
🇫🇷Toulouse, Occitanie, France
Hospital Sant Joan de Deu /ID# 37358
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Medizinische Universitaet Graz /ID# 26126
🇦🇹Graz, Steiermark, Austria
CHRU Lille - Hopital Claude Huriez /ID# 25449
🇫🇷Lille, Nord, France
Oslo Universitetssykehus, Radiumhospitalet /ID# 46402
🇳🇴Oslo, Norway
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682
🇵🇹Lisboa, Portugal
Puerto Rico Children Hospital /ID# 47742
🇵🇷Bayamon, Puerto Rico
Children's Speciality Center /ID# 11503
🇺🇸Burlington, Vermont, United States
CHRU Tours - Hopital Bretonneau /ID# 27126
🇫🇷Tours CEDEX 9, Indre-et-Loire, France
Azienda Ospedaliero Universitaria Meyer /ID# 26123
🇮🇹Florence, Firenze, Italy
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074
🇮🇹Rome, Roma, Italy
Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077
🇮🇹Brescia, 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
Queen Silvia Children's Hosp /ID# 26125
🇸🇪Gothenburg, Vastra Gotalands Lan, Sweden
AP-HP - Hopital Necker /ID# 25442
🇫🇷Paris, France
Asklepios Klinik Sankt Augustin /ID# 41622
🇩🇪Sankt Augustin, Germany
St. Christopher's Hospital /ID# 24385
🇺🇸Philadelphia, Pennsylvania, United States