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| 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 |
| 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:
|
|
Methotrexate Treatment Arm
For patients taking Methotrexate
|
Drug: Methotrexate
As prescribed by treating physician
Other Names:
|
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 |
Departments of rheumatology
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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| Study Director: | Hartmut Kupper, MD | Abbott |
More Information
| 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 |
|
JIA Juvenile Idiopathic Arthritis Juvenile Arthritis Polyarticular JIA |
|
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 |