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Juvenile Idiopathic Arthritis (JIA) Registry (STRIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00783510
First received: October 28, 2008
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
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 Intervention
Juvenile Idiopathic Arthritis JIA Biological: adalimumab Drug: Methotrexate

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 800
Study Start Date: July 2008
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783510

  Hide Study Locations
Locations
United States, Arizona
Arizona Arthritis and Rheumatology Research, PLLC /ID# 21023
Paradise Valley, Arizona, United States, 85253
Catalina Pointe Clinical Research, Inc. /ID# 40227
Tucson, Arizona, United States, 85704
United States, Arkansas
Arkansas Children's Hospital /ID# 23505
Little Rock, Arkansas, United States, 72202
United States, California
Childrens Hospital Los Angeles (USC) /ID# 24386
Los Angeles, California, United States, 90027
United States, District of Columbia
Children's National Medical Center /ID# 23506
Washington, District of Columbia, United States, 20010
United States, Florida
Arthritis Associates South FL /ID# 17001
Delray Beach, Florida, United States, 33484
United States, Illinois
Ann Robert H. Lurie Childrens Hospital of Chicago /ID# 20966
Chicago, Illinois, United States, 60614
University of Chicago Medical Center /ID# 21981
Chicago, Illinois, United States, 60637
Methodist Medical Group Rheumatology /ID# 46343
Peoria, Illinois, United States, 61602
United States, Indiana
Riley Hospital for Children /ID# 11421
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville Hospital /ID# 23507
Louisville, Kentucky, United States, 40202
United States, Maryland
Arthritis Care Specialists of Maryland, PA /ID# 21961
Ellicott City, Maryland, United States, 21042
United States, Massachusetts
Tufts Medical Center /ID# 21965
Boston, Massachusetts, United States, 02111
United States, Nebraska
Creighton University Medical Center /ID# 11423
Omaha, Nebraska, United States, 68131
United States, New Jersey
Saint Barnabas Ambulatory Care Center /ID# 21025
Livingston, New Jersey, United States, 07039
United States, New York
Cohen Children's Medical Center of New York /ID# 21022
New Hyde Park, New York, United States, 11040
University of Rochester Medical Center /ID# 20967
Rochester, New York, United States, 14642
New York Medical College /ID# 21964
Valhalla, New York, United States, 10595
United States, North Carolina
Duke Cancer Center /ID# 22904
Durham, North Carolina, United States, 27710
United States, North Dakota
Bone Spine Sports Clinic/Medcenter One /ID# 21962
Bismarck, North Dakota, United States, 58506
United States, Ohio
Akron Childrens Hospital /ID# 22907
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center /ID# 14101
Cincinnati, Ohio, United States, 45229
Nationwide Childrens Hospital /ID# 21963
Columbus, Ohio, United States, 43205
United States, Oregon
Legacy Emanuel Children's Hospital /ID# 14102
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Christopher's Hospital for Children /ID# 24385
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Tennessee
Arthritis Associates, PLLC /ID# 44462
Hixson, Tennessee, United States, 37343
Dr. Ramesh Gupta, Memphis, TN /ID# 45342
Memphis, Tennessee, United States, 38119
United States, Texas
Scott & White Health Care - Round Rock /ID# 36762
Round Rock, Texas, United States, 78665
United States, Utah
University of Utah /ID# 21041
Salt Lake City, Utah, United States, 84108
United States, Vermont
Fletcher Allen Health Care, Inc. /ID# 11503
Burlington, Vermont, United States, 05401
United States, Washington
Seattle Children's Hospital /ID# 20968
Seattle, Washington, United States, 98105
United States, Wisconsin
Children's Hospital of Wisconsin /ID# 40226
Milwaukee, Wisconsin, United States, 53201
Australia
Womens and Childrens Hospital /ID# 59182
North Adelaide, Australia, 5006
Austria
Landeskrankenhaus Bregenz /ID# 26128
Bregenz, Austria, 6900
Landeskrankenhaus Universitaetsklinikum Graz /ID# 26126
Graz, Austria, 8036
Landes-Frauen und Kinderklinik Linz, Austria /ID# 39068
Linz, Austria, 4020
Medical University of Vienna /ID# 26127
Vienna, Austria, 1090
Czech Republic
Fakultni Nemocnice Brno /ID# 37343
Brno, Czech Republic, 61300
Klinika detskeho a dorostoveho lekarstvi /ID# 47401
Prague 2, Czech Republic, 12109
Revmatologicky ustav Praha /ID# 43344
Prague 2, Czech Republic, 128 50
Fakultni Nemocnice v Motole /ID# 37342
Prague 5, Czech Republic, 15006
Denmark
Aarhus University Hospital /ID# 25445
Aarhus N, Denmark, 8200
Rigshospitalet, Finsen Centre /ID# 25444
Copenhagen O, Denmark, 2100
France
CHU de Bordeaux /ID# 25454
Bordeaux, France, 33076
CHU Bicetre /ID# 25443
Le Kremlin Bicetre, France, 94270
CHRU Lille - Hospital Jeanne de Flandre /ID# 25449
Lille, France, 59037
Hopital Cochin /ID# 37345
Paris, France, 75014
Hospitalier Necker /ID# 25442
Paris, France, 75015
CHU de Rennes - Hospital Sud /ID# 27123
Rennes Cedex 2, France, 35203
CHU de Strasbourg - Hospital de Hautepierre /ID# 25450
Strasbourg, Cedex 1, France, 67098
CHU Toulouse /ID# 37347
Toulouse Cedex 9, France, 31059
Hopital Bretonneau - CHU Tours /ID# 27126
Tours Cedex 9, France, 37044
Centre Hospitalier Univeritaire de Nancy /ID# 25452
Vandoeuvre les Nancy, France, 54500
Germany
Helios Klinikum Berlin Buch /ID# 37348
Berlin, Germany, 13125
Charite Universitatesmedizin Berlin, CCM /ID# 41623
Berlin, Germany, 13353
Klinikum Bremen Mitte gGmbH /ID# 45942
Bremen, Germany, 28177
Klinikum Dortmund gGmbH /ID# 44003
Dortmund, Germany, 44137
German Center for Rheumatology in Children and Adolescents /ID# 39069
Garmisch-Partenkirchen, Germany, 82467
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223
Hamburg, Germany, 22081
Klinikum St. Georg gGmbH /ID# 37349
Leipzig, Germany, 04129
Asklepios Klinik Sankt Augustin GmbH /ID# 41622
Sankt Augustin, Germany, 53757
Universitaetsklinikum Tuebingen /ID# 39070
Tuebingen, Germany, 72076
Rheumazentrum Wedel /ID# 37350
Wedel, Germany, 22880
Greece
Children`s Hospital P. A. Kyriakou /ID# 25448
Athens, Greece, 11527
General Hospital of Thessaloniki "Hippokration" /ID# 25447
Thessaloniki, Greece, 54642
Hungary
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095
Budapest, Hungary, 1023
Debreceni Egyetem Klinikai Kozpont /ID# 95863
Debrecen, Hungary, 4032
Italy
Universita degli Studi di Brescia /ID# 39077
Brescia, Italy, 25123
Universita di Catania /ID# 39075
Catania, Italy, 95100
Ospedale Policlinico-Universita degli Studi di Chieti /ID# 37353
Chieti, Italy, 66100
Azienda Ospedaliera Universitaria Meyer /ID# 26123
Florence, Italy, 50139
IRCCS Istituto G. Gaslini /ID# 26668
Genoa, Italy, 16147
Fondazione IRCCS Ca Granda, Ospedale Policlinico di Milano /ID# 26124
Milan, Italy, 20112
Azienda Ospedaliera Universita degli studi Federico II /ID# 39072
Naples, Italy, 80131
Azienda Ospedaliera Universita degli studi Federico II /ID# 39078
Naples, Italy, 88131
Universita di Padova /ID# 39079
Padua, Italy, 35128
Fondazione IRCCS Policlinico S. Matteo Universita di Pavia /ID# 39076
Pavia, Italy, 27100
Ospedale Pediatrico Bambino Gesu /ID# 39074
Rome, Italy, 00165
Netherlands
University Medical Center Utrecht /ID# 48842
Utrecht, Netherlands, 3584 EA
Norway
Rikshospitalet HF /ID# 46402
Oslo, Norway, 0027
Portugal
Hospital Garcia de Orta, E.P.E /ID# 37355
Almada, Portugal, 2805-267
Hospital de Santa Maria /ID# 42682
Lisbon, Portugal, 1649-035
Hospital Geral Santo Antonio, Centro Hospitalar do Porto EPE /ID# 39081
Porto, Portugal, 4099-001
Puerto Rico
Puerto Rico Children Hospital /ID# 47742
Bayamon, Puerto Rico, 00959
Centro Reumatologie Pediatrico /ID# 61047
Bayamon, Puerto Rico, 00960
Slovakia
Narodny ustav reumatickych chorob Piestany /ID# 38102
Piestany, Slovakia, 92112
Spain
Hospital Universitario Vall d'Hebron /ID# 37357
Barcelona, Spain, 08035
Hospital Sant Joan de Deu, Althaia /ID# 37358
Esplugues (Barcelona), Spain, 08950
Hospital Infantil Universitario del Nino Jesus /ID# 37360
Madrid, Spain, 28009
Hospital Universitario Ramon y Cajal /ID# 41624
Madrid, Spain, 28034
Severo Ochoa Hospital /ID# 41751
Madrid, Spain, 28911
Hospital Universitario La Fe /ID# 37359
Valencia, Spain, 46026
Sweden
The Queen Silvia Children's Hospital /ID# 26125
Gothenburg, Sweden, 416 85
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Hartmut Kupper, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00783510     History of Changes
Other Study ID Numbers: P10-262
Study First Received: October 28, 2008
Last Updated: April 7, 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Polyarticular JIA
Juvenile Arthritis
Juvenile Idiopathic Arthritis
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

ClinicalTrials.gov processed this record on June 22, 2017