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Juvenile Idiopathic Arthritis (JIA) Registry (STRIVE)
This study is currently recruiting participants.
Verified April 2012 by Abbott

First Received on October 28, 2008.   Last Updated on April 30, 2012   History of Changes
Sponsor: Abbott
Information provided by (Responsible Party): Abbott
ClinicalTrials.gov Identifier: NCT00783510
  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.


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 Moderate to Severe Active Polyarticular or Polyarticular Course Juvenile Idiopathic Arthritis (JIA)- STRIVE

Resource links provided by NLM:


Further study details as provided by Abbott:

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: June 2008
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (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 Names:
  • adalimumab
  • HUMIRA®
Methotrexate Treatment Arm
For patients taking Methotrexate
Drug: Methotrexate
As prescribed by treating physician
Other Names:
  • Methotrexate
  • MTX

Detailed Description:

The approved age range for HUMIRA in the U.S., EU and in Australia is 4 years of age and older. Patients who discontinue from the registry before 10 years will be offered to participate in the direct to Health Care Provider follow-up process.

  Eligibility

Ages Eligible for Study:   4 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:
  • 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 Abbott 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.
  • 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), 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783510

Contacts
Contact: Rebecca Prahl 847-937-1324 rebecca.prahl@abbott.com
Contact: Debbie Tokimoto, MPH, CCRA 847-938-9415 debbie.tokimoto@abbott.com

  Show 107 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Hartmut Kupper, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00783510     History of Changes
Other Study ID Numbers: P10-262
Study First Received: October 28, 2008
Last Updated: April 30, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - French Health Products Safety Agency
Germany: Paul-Ehrlich-Institut
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency

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

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 May 23, 2012