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: August 20, 2014
Last verified: August 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 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 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 All the Treated Patient Population.

  • Pediatric American College of Rheumatology (PedACR)50 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
    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: Duration of study ] [ Designated as safety issue: No ]
    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: Duration of the study ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: Months 1,3, 6 and every 6 months through Year 5. ] [ Designated as safety issue: No ]
    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. Starting at Year 6, patients will be followed annually for SAEs, congestive heart failure (CHF), pregnancies and malignancies through Year 10. 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
Genders Eligible for Study:   Both
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

  Show 93 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jasmina Kalabic, MD AbbVie
  More 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: August 20, 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
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
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 September 29, 2014