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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00783510




Registration number
NCT00783510
Ethics application status
Date submitted
28/10/2008
Date registered
31/10/2008
Date last updated
23/02/2024

Titles & IDs
Public title
Juvenile Idiopathic Arthritis (JIA) Registry
Scientific 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
Secondary ID [1] 0 0
P10-262
Universal Trial Number (UTN)
Trial acronym
STRIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 0 0
JIA 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - adalimumab
Treatment: Drugs - Methotrexate

HUMIRA® Treatment Arm - For patients taking HUMIRA®

Methotrexate Treatment Arm - For patients taking Methotrexate


Treatment: Other: adalimumab
As prescribed by treating physician

Treatment: Drugs: Methotrexate
As prescribed by treating physician
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 10 years
Primary outcome [2] 0 0
Incidence of Adverse Events (AEs) of Interest
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [1] 0 0
Pediatric American College of Rheumatology (PedACR) 50
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Pediatric American College of Rheumatology (PedACR) 70
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Pediatric American College of Rheumatology (PedACR) - 30
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [4] 0 0
Child Health Questionnaire (CHQ-PF50)
Timepoint [4] 0 0
Assessed in months 1,3, 6 and every 6 months through Year 5
Secondary outcome [5] 0 0
Pediatric American College of Rheumatology (PedACR) 90
Timepoint [5] 0 0
Up to 10 years
Secondary outcome [6] 0 0
Juvenile arthritis disease activity score (JADAS)
Timepoint [6] 0 0
Assessed in months 1,3, 6 and every 6 months through Year 5
Secondary outcome [7] 0 0
Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ)
Timepoint [7] 0 0
Assessed in months 1,3, 6 and every 6 months through Year 5

Eligibility
Key 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.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2024
Sample size
Target
Accrual to date
Final
849
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Duplicate_Womens and Childrens Hospital /ID# 59182 - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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Arkansas
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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Massachusetts
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Nebraska
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Vermont
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Washington
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United States of America
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Wisconsin
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Austria
State/province [25] 0 0
Oberoesterreich
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Austria
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Steiermark
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Austria
State/province [27] 0 0
Vorarlberg
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Austria
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Wien
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Czechia
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Brno
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Czechia
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Praha
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Denmark
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Midtjylland
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Denmark
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Copenhagen
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France
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Gironde
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Nord
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Occitanie
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France
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Le Kremlin Bicetre
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France
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Paris
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France
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Rennes
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Germany
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Baden-Wuerttemberg
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Germany
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Berlin
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Germany
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Bremen
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Germany
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Dortmund
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Germany
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Garmisch-Patenkirchen
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Sankt Augustin
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Germany
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Wedel
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Greece
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Attiki
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Greece
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Thessaloniki
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Hungary
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Hajdu-Bihar
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Hungary
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Budapest
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Italy
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Firenze
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Italy
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Roma
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Italy
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Brescia
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Italy
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Catania
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Italy
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Chieti
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Italy
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Genova
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Italy
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Milan
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Italy
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Naples
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Italy
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Napoli
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Italy
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Pavia
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Netherlands
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Utrecht
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Norway
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Oslo
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Portugal
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Almada
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Portugal
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Lisboa
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Portugal
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Porto
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Puerto Rico
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Bayamon
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Slovakia
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Piestany
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Sweden
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Vastra Gotalands Lan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00783510
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00783510