Trial Review

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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
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
North Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Vermont
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Austria
State/province [25] 0 0
Oberoesterreich
Country [26] 0 0
Austria
State/province [26] 0 0
Steiermark
Country [27] 0 0
Austria
State/province [27] 0 0
Vorarlberg
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha
Country [31] 0 0
Denmark
State/province [31] 0 0
Midtjylland
Country [32] 0 0
Denmark
State/province [32] 0 0
Copenhagen
Country [33] 0 0
France
State/province [33] 0 0
Bas-Rhin
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France
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Gironde
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France
State/province [35] 0 0
Indre-et-Loire
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France
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Meurthe-et-Moselle
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France
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Nord
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France
State/province [38] 0 0
Occitanie
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France
State/province [39] 0 0
Le Kremlin Bicetre
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Rennes
Country [42] 0 0
Germany
State/province [42] 0 0
Baden-Wuerttemberg
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Bremen
Country [45] 0 0
Germany
State/province [45] 0 0
Dortmund
Country [46] 0 0
Germany
State/province [46] 0 0
Garmisch-Patenkirchen
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Leipzig
Country [49] 0 0
Germany
State/province [49] 0 0
Sankt Augustin
Country [50] 0 0
Germany
State/province [50] 0 0
Wedel
Country [51] 0 0
Greece
State/province [51] 0 0
Attiki
Country [52] 0 0
Greece
State/province [52] 0 0
Thessaloniki
Country [53] 0 0
Hungary
State/province [53] 0 0
Hajdu-Bihar
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Italy
State/province [55] 0 0
Firenze
Country [56] 0 0
Italy
State/province [56] 0 0
Roma
Country [57] 0 0
Italy
State/province [57] 0 0
Brescia
Country [58] 0 0
Italy
State/province [58] 0 0
Catania
Country [59] 0 0
Italy
State/province [59] 0 0
Chieti
Country [60] 0 0
Italy
State/province [60] 0 0
Genova
Country [61] 0 0
Italy
State/province [61] 0 0
Milan
Country [62] 0 0
Italy
State/province [62] 0 0
Naples
Country [63] 0 0
Italy
State/province [63] 0 0
Napoli
Country [64] 0 0
Italy
State/province [64] 0 0
Pavia
Country [65] 0 0
Netherlands
State/province [65] 0 0
Utrecht
Country [66] 0 0
Norway
State/province [66] 0 0
Oslo
Country [67] 0 0
Portugal
State/province [67] 0 0
Almada
Country [68] 0 0
Portugal
State/province [68] 0 0
Lisboa
Country [69] 0 0
Portugal
State/province [69] 0 0
Porto
Country [70] 0 0
Puerto Rico
State/province [70] 0 0
Bayamon
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Slovakia
State/province [71] 0 0
Piestany
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
Country [73] 0 0
Spain
State/province [73] 0 0
Madrid
Country [74] 0 0
Spain
State/province [74] 0 0
Valencia
Country [75] 0 0
Sweden
State/province [75] 0 0
Vastra Gotalands Lan

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00783510