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Juvenile Idiopathic Arthritis (JIA) Registry (STRIVE)

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ClinicalTrials.gov Identifier: NCT00783510
Recruitment Status : Active, not recruiting
First Posted : October 31, 2008
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Juvenile Idiopathic Arthritis JIA 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
Actual Enrollment : 833 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 11, 2008
Estimated Primary Completion Date : January 8, 2024
Estimated Study Completion Date : January 8, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HUMIRA® Treatment Arm
For patients taking HUMIRA®
Biological: adalimumab
As prescribed by treating physician
Other Name: HUMIRA®

Methotrexate Treatment Arm
For patients taking Methotrexate
Drug: Methotrexate
As prescribed by treating physician
Other Name: MTX




Primary Outcome Measures :
  1. Incidence of Serious Adverse Events (SAEs) [ Time Frame: 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.

  2. Incidence of Adverse Events (AEs) of Interest [ Time Frame: 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 :
  1. Pediatric American College of Rheumatology (PedACR) 50 [ Time Frame: Up to 10 years ]
    Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.

  2. Pediatric American College of Rheumatology (PedACR) 70 [ Time Frame: Up to 10 years ]
    Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.

  3. Pediatric American College of Rheumatology (PedACR) - 30 [ Time Frame: Up to 10 years ]
    Effectiveness data will be analyzed as observed and will be summarized for All the Treated Patient Population.

  4. Child Health Questionnaire (CHQ-PF50) [ Time Frame: 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.

  5. Pediatric American College of Rheumatology (PedACR) 90 [ Time Frame: Up to 10 years ]
    Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.

  6. Juvenile arthritis disease activity score (JADAS) [ Time Frame: 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.

  7. Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ) [ Time Frame: Assessed in months 1,3, 6 and every 6 months through Year 5 ]
    Effectiveness of therapy through clinical assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783510


  Hide Study Locations
Locations
United States, Arizona
AZ Arthritis and Rheum Researc
Phoenix, Arizona, United States, 85032-9306
Catalina Pointe Clinical Res
Tucson, Arizona, United States, 85704
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Childrens Hospital LA
Los Angeles, California, United States, 90027
United States, District of Columbia
Children's Natl Med Ctr
Washington, District of Columbia, United States, 20010
United States, Florida
Arthritis Associates South FL
Delray Beach, Florida, United States, 33484
United States, Illinois
Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637-1443
Methodist Medical Group Rheum
Peoria, Illinois, United States, 61602
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Arthritis Care Spec. of MD
Ellicott City, Maryland, United States, 21042
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Nebraska
Creighton Univ Med Ctr
Omaha, Nebraska, United States, 68131
United States, New Jersey
St. Barnabas Ambulatory Care
West Orange, New Jersey, United States, 07052
United States, New York
North Shore University Hospital
New Hyde Park, New York, United States, 11040
Univ Rochester Med Ctr
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, North Dakota
Bone Spine Sports/Medctr One
Bismarck, North Dakota, United States, 58501
United States, Ohio
Akron Childrens Hospital
Akron, Ohio, United States, 44308
University of Cincinnati
Cincinnati, Ohio, United States, 45267-2827
Nationwide Childrens Hospital
Columbus, Ohio, United States, 43205
United States, Oregon
Legacy Emanuel Child Hosp
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Christopher's Hospital
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
Arthritis Associates, PLLC
Kingsport, Tennessee, United States, 37660
Dr. Ramesh Gupta
Memphis, Tennessee, United States, 38119
United States, Texas
Scott & White Health Care
Round Rock, Texas, United States, 78665
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112-5500
United States, Vermont
Children's Speciality Center
Burlington, Vermont, United States, 05401
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Children's Hospital Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
Womens and Childrens Hospital
Adelaide, South Australia, Australia, 5006
Austria
AKH Wien
Vienna, Wein, Austria, 1090
Landeskrankenhaus Bregenz
Bregenz, Austria, 6900
LKH-Univ. Klinikum Graz
Graz, Austria, 8036
Czechia
Revmatologicky ustav Praha
Prague 2, Praha 2, Czechia, 128 00
Fakultni Nemocnice Brno
Brno, Czechia, 625 00
Klinika detskeho a dorosto lek
Prague, Czechia, 121 00
Fakultni Nemocnice v Motole
Prague, Czechia, 150 00
Denmark
Aarhus University Hospital
Aarhus C, Midtjylland, Denmark, 8000
Rigshospitalet, Finsen Centre
Copenhagen, Denmark, 2100
France
CHRU Lille - Hôpital Claude Huriez
Lille CEDEX, Hauts-de-France, France, 59045
CHU NANCY - Hôpital Brabois Adultes
Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
CHU Toulouse
Toulouse CEDEX 3, Occitanie, France, 31025
CHU Bordeaux-Hopital Pellegrin
Bordeaux, France, 33076
CHU Bicetre
Le Kremlin Bicetre, France, 94270
Groupe Hospitalier Cochin
Paris, France, 75014
Hospitalier Necker
Paris, France, 75015
CHU de Rennes - Hospital Sud
Rennes, France, 35203
CHU Strasbourg Hautepierre Hos
Strasbourg, France, 67200
Hopital Bretonneau - CHU Tours
Tours, France, 37044
Germany
Charité Universitätsmedizin Campus Mitte
Berlin, Germany, 10117
Helios Klinikum Berlin Buch
Berlin, Germany, 13125
Klinikum Bremen Mitte gGmbH
Bremen, Germany, 28205
Klinikum Dortmund gGmbH
Dortmund, Germany, 44137
Center Rheumatology Child&Adol
Garmisch-partenkirchen, Germany, 82467
Kinder- & Jugendrheumatologie
Hamburg, Germany, 22081
Klinikum St. Georg gGmbH
Leipzig, Germany, 04129
Asklepios Klinik St. Augustin
Sankt Augustin, Germany, 53757
Universitatsklinikum Tubingen
Tuebingen, Germany, 72076
Rheumazentrum Wedel
Wedel, Germany, 22880
Greece
Children`s Hosp P. A. Kyriakou
Athens, Greece, 11527
Genl Hosp Thessaloniki Hipp
Thessaloniki, Greece, 54642
Hungary
Orszagos Reumatologiai es Fizi
Budapest, Hungary, 1023
Debreceni Egyetem Klinikai Koz
Debrecen, Hungary, 4032
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardia, Italy, 20122
Azienda Ospedaliera Univ. Meyer
Florence, Toscana, Italy, 50139
Univ. degli Studi di Brescia
Brescia, Italy, 25123
Universita di Catania
Catania, Italy, 95123
Univ degli Studi G D'Annunzio
Chieti, Italy, 66100
IRCCS Istituto G. Gaslini
Genoa, Italy, 16148
University of Naples Federico
Naples, Italy, 80131
Fondazione IRCCS Policlinico
Pavia, Italy, 27100
Osp. Pediatrico Bambino Gesu
Rome, Italy, 00146
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Norway
Oslo Universitetssykehus, Radiumhospitalet
Oslo, Norway, 0310
Puerto Rico
Centro de Reumatologia Pediatrico de Puerto Rico
Bayamon, Puerto Rico, 00959
Puerto Rico Children Hospital
Bayamon, Puerto Rico, 00960
Slovakia
Narodny ustav reumatickych cho
Pieštany, Slovakia, 921 01
Spain
Hospital Univ Vall d'Hebron
Barcelona, Spain, 08035
Hospital Sant Joan de Deu
Esplugues de Llobregat, Spain, 08950
Severo Ochoa Hospital
Leganes-madrid, Spain, 28911
Hosp Infantil Univ Nino Jesus
Madrid, Spain, 28009
Hospital Univ Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario La Fe
Valencia, Spain, 46026
Sweden
Queen Silvia Children's Hosp
Goteborg, Sweden, 416 85
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT00783510     History of Changes
Other Study ID Numbers: P10-262
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
JIA
Juvenile Idiopathic Arthritis
Juvenile Arthritis
Polyarticular JIA
Polyarticular-course JIA

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents