Juvenile Idiopathic Arthritis (JIA) Registry



Status:Active, not recruiting
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:2 - 17
Updated:12/16/2018
Start Date:July 11, 2008
End Date:June 30, 2021

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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

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.

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. From Year 6 through Year 10 SAEs, a
subset of AESI that includes congestive heart failure (CHF), malignancies, AEs at least
possibly related to and/or leading to discontinuation of registry treatment and pregnancies
will be collected. 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.

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)
We found this trial at
33
sites
Ellicott City, Maryland 21042
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Ellicott City, MD
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Adelaide, South Australia
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Adelaide,
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214 West Bowery Street
Akron, Ohio 44308
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from
Akron, OH
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Bismarck, North Dakota 58501
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from
Bismarck, ND
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Boston, Massachusetts 02111
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from
Boston, MA
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Burlington, Vermont 05401
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Burlington, VT
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Chicago, IL
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Chicago, Illinois 60637
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Chicago, IL
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Cincinnati, Ohio 45267
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from
Cincinnati, OH
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700 Children's Drive
Columbus, Ohio 43205
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Columbus, OH
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5130 Linton Boulevard
Delray Beach, Florida 33484
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Delray Beach, FL
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Durham, North Carolina 27710
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Durham, NC
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Indianapolis, Indiana 46202
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from
Indianapolis, IN
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Kingsport, Tennessee 37660
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Kingsport, TN
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1 Children's Way
Little Rock, Arkansas 72202
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Little Rock, AR
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Los Angeles, California 90027
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Los Angeles, CA
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Louisville, Kentucky 40202
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Louisville, KY
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6005 Park Avenue
Memphis, Tennessee 38119
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Memphis, TN
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8915 West Connell Court
Milwaukee, Wisconsin 53201
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from
Milwaukee, WI
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New Hyde Park, New York 11040
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from
New Hyde Park, NY
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601 North 30th Street
Omaha, Nebraska 68131
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Omaha, NE
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Peoria, IL
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Philadelphia, Pennsylvania 19134
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Philadelphia, PA
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Phoenix, AZ
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Portland, Oregon 97227
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
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Rochester, NY
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Round Rock, Texas 78665
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Round Rock, TX
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Salt Lake City, Utah 84108
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Salt Lake City, UT
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4800 Sand Point Way Northeast
Seattle, Washington 98105
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Seattle, WA
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Tucson, AZ
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40 Sunshine Cottage Road
Valhalla, New York 10595
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Valhalla, NY
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Washington, District of Columbia 20010
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Washington,
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West Orange, New Jersey 07052
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from
West Orange, NJ
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