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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00783510
Ethics application status
Date submitted
28/10/2008
Date registered
31/10/2008
Date last updated
21/08/2019

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
Other interventions - adalimumab
Treatment: Drugs - Methotrexate

HUMIRA® Treatment Arm - For patients taking HUMIRA®

Methotrexate Treatment Arm - For patients taking Methotrexate


Other interventions: adalimumab
As prescribed by treating physician

Treatment: Drugs: Methotrexate
As prescribed by treating physician

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Serious Adverse Events (SAEs) - 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.
Timepoint [1] 0 0
Up to 10 years
Primary outcome [2] 0 0
Incidence of Adverse Events (AEs) of Interest - 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.
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [1] 0 0
Pediatric American College of Rheumatology (PedACR) 50 - Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Pediatric American College of Rheumatology (PedACR) 70 - Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Pediatric American College of Rheumatology (PedACR) - 30 - Effectiveness data will be analyzed as observed and will be summarized for All the Treated Patient Population.
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [4] 0 0
Child Health Questionnaire (CHQ-PF50) - The results will be summarized at each visit and will be used in exploratory analyses.
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 - Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Timepoint [5] 0 0
Up to 10 years
Secondary outcome [6] 0 0
Juvenile arthritis disease activity score (JADAS) - 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.
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) - Effectiveness of therapy through clinical assessment.
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
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
Wien
Country [26] 0 0
Austria
State/province [26] 0 0
Bregenz
Country [27] 0 0
Austria
State/province [27] 0 0
Graz
Country [28] 0 0
Austria
State/province [28] 0 0
Linz
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 2
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 5
Country [31] 0 0
Czechia
State/province [31] 0 0
Brno
Country [32] 0 0
Czechia
State/province [32] 0 0
Prague
Country [33] 0 0
Denmark
State/province [33] 0 0
Midtjylland
Country [34] 0 0
Denmark
State/province [34] 0 0
Copenhagen
Country [35] 0 0
France
State/province [35] 0 0
Hauts-de-France
Country [36] 0 0
France
State/province [36] 0 0
Indre-et-Loire
Country [37] 0 0
France
State/province [37] 0 0
Meurthe-et-Moselle
Country [38] 0 0
France
State/province [38] 0 0
Occitanie
Country [39] 0 0
France
State/province [39] 0 0
Bordeaux
Country [40] 0 0
France
State/province [40] 0 0
Le Kremlin Bicetre
Country [41] 0 0
France
State/province [41] 0 0
Paris
Country [42] 0 0
France
State/province [42] 0 0
Rennes
Country [43] 0 0
France
State/province [43] 0 0
Strasbourg
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Bremen
Country [46] 0 0
Germany
State/province [46] 0 0
Dortmund
Country [47] 0 0
Germany
State/province [47] 0 0
Garmisch-partenkirchen
Country [48] 0 0
Germany
State/province [48] 0 0
Hamburg
Country [49] 0 0
Germany
State/province [49] 0 0
Leipzig
Country [50] 0 0
Germany
State/province [50] 0 0
Sankt Augustin
Country [51] 0 0
Germany
State/province [51] 0 0
Tuebingen
Country [52] 0 0
Germany
State/province [52] 0 0
Wedel
Country [53] 0 0
Greece
State/province [53] 0 0
Athens
Country [54] 0 0
Greece
State/province [54] 0 0
Thessaloniki
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Debrecen
Country [57] 0 0
Italy
State/province [57] 0 0
Lombardia
Country [58] 0 0
Italy
State/province [58] 0 0
Toscana
Country [59] 0 0
Italy
State/province [59] 0 0
Brescia
Country [60] 0 0
Italy
State/province [60] 0 0
Catania
Country [61] 0 0
Italy
State/province [61] 0 0
Chieti
Country [62] 0 0
Italy
State/province [62] 0 0
Genoa
Country [63] 0 0
Italy
State/province [63] 0 0
Naples
Country [64] 0 0
Italy
State/province [64] 0 0
Pavia
Country [65] 0 0
Italy
State/province [65] 0 0
Rome
Country [66] 0 0
Netherlands
State/province [66] 0 0
Utrecht
Country [67] 0 0
Norway
State/province [67] 0 0
Oslo
Country [68] 0 0
Portugal
State/province [68] 0 0
Setubal
Country [69] 0 0
Portugal
State/province [69] 0 0
Lisboa
Country [70] 0 0
Portugal
State/province [70] 0 0
Porto
Country [71] 0 0
Puerto Rico
State/province [71] 0 0
Bayamon
Country [72] 0 0
Slovakia
State/province [72] 0 0
PieŇ°tany
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona
Country [74] 0 0
Spain
State/province [74] 0 0
Esplugues de Llobregat
Country [75] 0 0
Spain
State/province [75] 0 0
Leganes-madrid
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Spain
State/province [77] 0 0
Valencia
Country [78] 0 0
Sweden
State/province [78] 0 0
Goteborg

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/show/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
Other publications