Juvenile Idiopathic Arthritis (JIA) Registry (STRIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Arthritis; JIA
• Intervention / Treatment: Biological: adalimumab; Drug: Methotrexate

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.

• Study Type: Observational
• Enrollment (Actual): 849

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5006
      • Duplicate_Womens and Childrens Hospital /ID# 59182
• Austria
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4021
      • Duplicate_Kepler Universitaetsklinikum GmbH /ID# 39068
  • Steiermark
    • Graz, Steiermark, Austria, 8010
      • Medizinische Universitaet Graz /ID# 26126
  • Vorarlberg
    • Bregenz, Vorarlberg, Austria, 6900
      • Landeskrankenhaus Bregenz /ID# 26128
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 26127
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni Nemocnice Brno /ID# 37343
  • Praha, Czechia, 128 00
    • Revmatologicky ustav v Praze /ID# 43344
  • Praha, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze /ID# 47401
  • Praha, Czechia, 150 06
    • Fakultni Nemocnice v Motole /ID# 37342
• Denmark
  • Copenhagen, Denmark, 2100
    • Duplicate_Rigshospitalet, Finsen Centre /ID# 25444
  • Midtjylland
    • Aarhus N, Midtjylland, Denmark, 8200
      • Aarhus University Hospital /ID# 25445
• France
  • Le Kremlin Bicetre, France, 94270
    • AP-HP - Hôpital Bicêtre /ID# 25443
  • Paris, France, 75015
    • AP-HP - Hopital Necker /ID# 25442
  • Paris, France, 75014
    • Duplicate_AP-HP - Hopital Cochin /ID# 37345
  • Rennes, France, 35203
    • Duplicate_CHU de Rennes - Hospital Sud /ID# 27123
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67200
      • CHU Strasbourg - Hopital de Hautepierre /ID# 25450
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Duplicate_CHU Bordeaux - Hopital Pellegrin /ID# 25454
  • Indre-et-Loire
    • Tours CEDEX 9, Indre-et-Loire, France, 37044
      • CHRU Tours - Hopital Bretonneau /ID# 27126
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 25452
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 25449
  • Occitanie
    • Toulouse, Occitanie, France, 31300
      • CHU Toulouse /ID# 37347
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch /ID# 37348
  • Bremen, Germany, 28205
    • Klinikum Bremen Mitte /ID# 45942
  • Dortmund, Germany, 44137
    • Klinikum Dortmund gGmbH /ID# 44003
  • Garmisch-Patenkirchen, Germany, 82467
    • Center Rheumatology Child&Adol /ID# 39069
  • Hamburg, Germany, 22081
    • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223
  • Leipzig, Germany, 04129
    • Klinikum St. Georg gGmbH /ID# 37349
  • Sankt Augustin, Germany, 53757
    • Asklepios Klinik Sankt Augustin /ID# 41622
  • Wedel, Germany, 22880
    • Rheumazentrum Wedel /ID# 37350
  • Baden-Wuerttemberg
    • Tubingen, Baden-Wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen /ID# 39070
• Greece
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki Hippokrateio /ID# 25447
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Children's Hosp P. A. Kyriakou /ID# 25448
• Hungary
  • Budapest, Hungary, 1023
    • Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont /ID# 95863
• Italy
  • Brescia, Italy, 25123
    • Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077
  • Catania, Italy, 95123
    • Duplicate_Universita di Catania /ID# 39075
  • Chieti, Italy, 66100
    • Ospedale Ss. Annunziata /ID# 37353
  • Genova, Italy, 16147
    • Istituto Giannina Gaslini /ID# 26668
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124
  • Naples, Italy, 80131
    • Duplicate_Universita di Napoli Federico II /ID# 39078
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II /ID# 39072
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico /ID# 39076
  • Firenze
    • Florence, Firenze, Italy, 50139
      • Azienda Ospedaliero Universitaria Meyer /ID# 26123
  • Roma
    • Rome, Roma, Italy, 00165
      • IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 48842
• Norway
  • Oslo, Norway, 0310
    • Oslo Universitetssykehus, Radiumhospitalet /ID# 46402
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta, EPE /ID# 37355
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081
• Puerto Rico
  • Bayamon, Puerto Rico, 00959
    • Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047
  • Bayamon, Puerto Rico, 00960
    • Puerto Rico Children Hospital /ID# 47742
• Slovakia
  • Piestany, Slovakia, 921 12
    • Narodny ustav reumatickych chorob /ID# 38102
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 37357
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Nino Jesus /ID# 37360
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 41624
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 37359
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Deu /ID# 37358
  • Madrid
    • Leganes, Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa /ID# 41751
• Sweden
  • Vastra Gotalands Lan
    • Gothenburg, Vastra Gotalands Lan, Sweden, 416 85
      • Queen Silvia Children's Hosp /ID# 26125
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032-9306
      • AZ Arthritis and Rheumotology Research, PLLC /ID# 21023
    • Tucson, Arizona, United States, 85704
      • Catalina Pointe Clinical Research /ID# 40227
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital /ID# 23505
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles /ID# 24386
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2916
      • Children's National Medical Center /ID# 23506
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Duplicate_Arthritis Associates South FL /ID# 17001
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966
    • Chicago, Illinois, United States, 60637-1443
      • The University of Chicago Medical Center /ID# 21981
    • Peoria, Illinois, United States, 61602
      • Methodist Medical Group Rheum /ID# 46343
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University /ID# 11421
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville /ID# 23507
  • Maryland
    • Ellicott City, Maryland, United States, 21042
      • Arthritis Care Spec. of MD /ID# 21961
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts Medical Center /ID# 21965
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton Univ Med Ctr /ID# 11423
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • St. Barnabas Ambulatory Care /ID# 21025
  • New York
    • New Hyde Park, New York, United States, 11040
      • North Shore University Hospital /ID# 21022
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center /ID# 20967
    • Valhalla, New York, United States, 10595
      • New York Medical College /ID# 21964
  • North Carolina
    • Durham, North Carolina, United States, 27710-3000
      • Duke Cancer Center /ID# 22904
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Bone Spine Sports/Medctr One /ID# 21962
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital /ID# 22907
    • Cincinnati, Ohio, United States, 45267-0585
      • University of Cincinnati /ID# 14101
    • Columbus, Ohio, United States, 43205-2664
      • Nationwide Children's Hospital /ID# 21963
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Medical Center /ID# 14102
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • St. Christopher's Hospital /ID# 24385
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Arthritis Associates of Kingsport /ID# 44462
    • Memphis, Tennessee, United States, 38119
      • Dr. Ramesh Gupta /ID# 45342
  • Texas
    • Round Rock, Texas, United States, 78665
      • Scott & White Health Care /ID# 36762
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • University of Utah /ID# 21041
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Children's Speciality Center /ID# 11503
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital /ID# 20968
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HUMIRA® Treatment Arm; For patients taking HUMIRA®	Biological: adalimumab; As prescribed by treating physician; Other Names: HUMIRA®
Methotrexate Treatment Arm; For patients taking Methotrexate	Drug: Methotrexate; As prescribed by treating physician; Other Names: MTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2008
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 30, 2008
• First Posted (Estimated): October 31, 2008

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: JIA; Juvenile Idiopathic Arthritis; Juvenile Arthritis; Polyarticular JIA; Polyarticular-course JIA
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Tumor Necrosis Factor Inhibitors; Adalimumab; Methotrexate
• Other Study ID Numbers: P10-262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No