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 30, 2014
Last verified: April 2014
  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 enrollment into one of the treatment arms.


Condition Intervention
Juvenile Idiopathic Arthritis
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 Registry 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:

Primary Outcome Measures:
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
    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: Duration of study ] [ Designated as safety issue: Yes ]
    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: Duration of study ] [ Designated as safety issue: No ]
    Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.

  • PedACR50 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
    Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.

  • PedACR70 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
    Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.

  • PedACR90 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
    Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.

  • Juvenile arthritis disease activity score [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
    Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.


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:

The approved age range for HUMIRA in the U.S., 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Departments of Rheumatology

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 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
Site Reference ID/Investigator# 21023
Paradise Valley, Arizona, United States, 85253
Site Reference ID/Investigator# 40227
Tucson, Arizona, United States, 85704
United States, Arkansas
Site Reference ID/Investigator# 23505
Little Rock, Arkansas, United States, 72202
United States, California
Site Reference ID/Investigator# 24386
Los Angeles, California, United States, 90027
United States, District of Columbia
Site Reference ID/Investigator# 23506
Washington, District of Columbia, United States, 20010
United States, Florida
Site Reference ID/Investigator# 17001
Delray Beach, Florida, United States, 33484
United States, Illinois
Site Reference ID/Investigator# 20966
Chicago, Illinois, United States, 60614
Site Reference ID/Investigator# 46343
Peoria, Illinois, United States, 61602
United States, Indiana
Site Reference ID/Investigator# 11421
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Site Reference ID/Investigator# 23507
Louisville, Kentucky, United States, 40202
United States, Maryland
Site Reference ID/Investigator# 21961
Ellicott City, Maryland, United States, 21042
United States, Massachusetts
Site Reference ID/Investigator# 21965
Boston, Massachusetts, United States, 02111
United States, Michigan
Site Reference ID/Investigator# 21981
Chicago, Michigan, United States, 60637
United States, Nebraska
Site Reference ID/Investigator# 11423
Omaha, Nebraska, United States, 68131
United States, New Jersey
Site Reference ID/Investigator# 21025
Livingston, New Jersey, United States, 07039
United States, New York
Site Reference ID/Investigator# 21022
New Hyde Park, New York, United States, 11040
Site Reference ID/Investigator# 20967
Rochester, New York, United States, 14642
Site Reference ID/Investigator# 21964
Valhalla, New York, United States, 10595
United States, North Carolina
Site Reference ID/Investigator# 22904
Durham, North Carolina, United States, 27710
United States, North Dakota
Site Reference ID/Investigator# 21962
Bismarck, North Dakota, United States, 58506
United States, Ohio
Site Reference ID/Investigator# 22907
Akron, Ohio, United States, 44308
Site Reference ID/Investigator# 14101
Cincinnati, Ohio, United States, 45229
Site Reference ID/Investigator# 21963
Columbus, Ohio, United States, 43205
United States, Oregon
Site Reference ID/Investigator# 14102
Portland, Oregon, United States, 97227
United States, Pennsylvania
Site Reference ID/Investigator# 24385
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Tennessee
Site Reference ID/Investigator# 44462
Hixson, Tennessee, United States, 37343
Site Reference ID/Investigator# 45342
Memphis, Tennessee, United States, 38119
United States, Texas
Site Reference ID/Investigator# 36762
Round Rock, Texas, United States, 78665
United States, Utah
Site Reference ID/Investigator# 21041
Salt Lake City, Utah, United States, 84108
United States, Vermont
Site Reference ID/Investigator# 11503
Burlington, Vermont, United States, 05401
United States, Washington
Site Reference ID/Investigator# 20968
Seattle, Washington, United States, 98105
United States, Wisconsin
Site Reference ID/Investigator# 40226
Milwaukee, Wisconsin, United States, 53201
Australia
Site Reference ID/Investigator# 59182
North Adelaide, Australia, 5006
Austria
Site Reference ID/Investigator# 26128
Bregenz, Austria, 6900
Site Reference ID/Investigator# 26126
Graz, Austria, 8036
Site Reference ID/Investigator# 39068
Linz, Austria, 4020
Site Reference ID/Investigator# 26127
Vienna, Austria, 1090
Czech Republic
Site Reference ID/Investigator# 37343
Brno, Czech Republic, 61300
Site Reference ID/Investigator# 43344
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 47401
Prague 2, Czech Republic, 12109
Site Reference ID/Investigator# 37342
Prague 5, Czech Republic, 15006
Denmark
Site Reference ID/Investigator# 25445
Aarhus N, Denmark, 8200
Site Reference ID/Investigator# 25444
Copenhagen O, Denmark, 2100
France
Site Reference ID/Investigator# 25454
Bordeaux, France, 33000
Site Reference ID/Investigator# 25443
Le Kremlin Bicetre, France, 94270
Site Reference ID/Investigator# 25449
Lille, France, 59037
Site Reference ID/Investigator# 37345
Paris, France, 75014
Site Reference ID/Investigator# 25442
Paris, France, 75015
Site Reference ID/Investigator# 27123
Rennes Cedex 2, France, 35203
Site Reference ID/Investigator# 25450
Strasbourg, Cedex 1, France, 67098
Site Reference ID/Investigator# 37347
Toulouse Cedex 9, France, 31059
Site Reference ID/Investigator# 27126
Tours Cedex 9, France, 37044
Site Reference ID/Investigator# 25452
Vandoeuvre les Nancy, France, 54500
Germany
Site Reference ID/Investigator# 41623
Berlin, Germany, 13353
Site Reference ID/Investigator# 37348
Berlin, Germany, 13125
Site Reference ID/Investigator# 45942
Bremen, Germany, 28177
Site Reference ID/Investigator# 44003
Dortmund, Germany, 44137
Site Reference ID/Investigator# 39069
Garmisch-Partenkirchen, Germany, 82467
Site Reference ID/Investigator# 39223
Hamburg, Germany, 22081
Site Reference ID/Investigator# 37349
Leipzig, Germany, 04129
Site Reference ID/Investigator# 41622
Sankt Augustin, Germany, 53757
Site Reference ID/Investigator# 39070
Tuebingen, Germany, 72076
Site Reference ID/Investigator# 37350
Wedel, Germany, 22880
Greece
Site Reference ID/Investigator# 25448
Athens, Greece, 11527
Site Reference ID/Investigator# 25447
Thessaloniki, Greece, 54642
Hungary
Site Reference ID/Investigator# 95095
Budapest, Hungary, 1023
Site Reference ID/Investigator# 95863
Debrecen, Hungary, 4032
Italy
Site Reference ID/Investigator# 39077
Brescia, Italy, 25123
Site Reference ID/Investigator# 39075
Catania, Italy, 95100
Site Reference ID/Investigator# 37353
Chieti, Italy, 66100
Site Reference ID/Investigator# 26123
Florence, Italy, 50139
Site Reference ID/Investigator# 26668
Genoa, Italy, 16147
Site Reference ID/Investigator# 26124
Milan, Italy, 20112
Site Reference ID/Investigator# 39072
Naples, Italy, 80131
Site Reference ID/Investigator# 39078
Naples, Italy, 88131
Site Reference ID/Investigator# 39079
Padua, Italy, 35128
Site Reference ID/Investigator# 39076
Pavia, Italy, 27100
Site Reference ID/Investigator# 39074
Rome, Italy, 00165
Netherlands
Site Reference ID/Investigator# 48842
Utrecht, Netherlands, 3584 EA
Norway
Site Reference ID/Investigator# 46402
Oslo, Norway, 0027
Portugal
Site Reference ID/Investigator# 37355
Almada, Portugal, 2801-951
Site Reference ID/Investigator# 42682
Lisbon, Portugal, 1649-035
Site Reference ID/Investigator# 39081
Porto, Portugal, 4099-001
Puerto Rico
Site Reference ID/Investigator# 47742
Bayamon, Puerto Rico, 00959
Site Reference ID/Investigator# 61047
Bayamon, Puerto Rico, 00960
Slovakia
Site Reference ID/Investigator# 38102
Piestany, Slovakia, 92112
Spain
Site Reference ID/Investigator# 37357
Barcelona, Spain, 08035
Site Reference ID/Investigator# 37358
Esplugues (Barcelona), Spain, 08950
Site Reference ID/Investigator# 37360
Madrid, Spain, 28009
Site Reference ID/Investigator# 41624
Madrid, Spain, 28034
Site Reference ID/Investigator# 41751
Madrid, Spain, 28911
Site Reference ID/Investigator# 37359
Valencia, Spain, 46026
Sweden
Site Reference ID/Investigator# 26125
Gothenburg, Sweden, 416 85
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jasmina Kalabic, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( 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 30, 2014
Health Authority: Czech Republic: State Institute for Drug Control
United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Hungary: National Institute of Pharmacy
Germany: Paul-Ehrlich-Institut
Norway: Norwegian Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Sweden: Regional Ethical Review Board
Denmark: Danish Dataprotection Agency
Netherlands: Independent Ethics Committee
Denmark: Ethics Committee
Germany: Ethics Commission
Spain: Ethics Committee
France: Conseil National de l'Ordre des Médecins
Italy: Ethics Committee
France: The Commission nationale de l’informatique et des libertés
Slovak Republic: Ethics Committee
Greece: Ethics Committee
Norway: Ethics Committee
Austria: Ethikkommission
Greece: National Organization of Medicines
Portugal: Ethics Committee for Clinical Research
Czech Republic: Ethics Committee
France: Institutional Ethical Committee
Portugal: Data Protection Agency

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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 July 23, 2014