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Juvenile Idiopathic ArthritisSTRIVENCT00783510

Juvenile Idiopathic Arthritis (JIA) Registry

An observational study of Juvenile Idiopathic Arthritis and JIA, run by AbbVie at 92 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Juvenile Idiopathic Arthritis, JIA
What is being tested?
adalimumab and Methotrexate
How many people
849 participants
Where
92 sitesin 17 countries
Study dates
11 Jul 2008to 1 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Patients who are diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA, (defined as arthritis affecting greater than 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA), prescribed and treated in a routine clinical setting either with Humira® (adalimumab), or MTX. Approximately 800 patients will be enrolled in the United States, EU countries, and Australia. Approximately 40 to 45 physicians will be included based on participation in prior AbbVie Humira sponsored clinical JIA studies.

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

92 sites in 17 countries.

92 sites in 17 countries

United States32 sites

  • Akron Children's Hospital /ID# 22907

    Akron, Ohio, 44308

  • Bone Spine Sports/Medctr One /ID# 21962

    Bismarck, North Dakota, 58501

  • Tufts Medical Center /ID# 21965

    Boston, Massachusetts, 02111-1552

  • Children's Speciality Center /ID# 11503

    Burlington, Vermont, 05401

  • Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center /ID# 21981

    Chicago, Illinois, 60637-1443

  • University of Cincinnati /ID# 14101

    Cincinnati, Ohio, 45267-0585

  • Nationwide Children's Hospital /ID# 21963

    Columbus, Ohio, 43205-2664

  • Duplicate_Arthritis Associates South FL /ID# 17001

    Delray Beach, Florida, 33484

  • Duke Cancer Center /ID# 22904

    Durham, North Carolina, 27710-3000

  • Arthritis Care Spec. of MD /ID# 21961

    Ellicott City, Maryland, 21042

  • Indiana University /ID# 11421

    Indianapolis, Indiana, 46202

  • Arthritis Associates of Kingsport /ID# 44462

    Kingsport, Tennessee, 37660

  • Arkansas Children's Hospital /ID# 23505

    Little Rock, Arkansas, 72202

  • Children's Hospital Los Angeles /ID# 24386

    Los Angeles, California, 90027

  • University of Louisville /ID# 23507

    Louisville, Kentucky, 40202

  • Dr. Ramesh Gupta /ID# 45342

    Memphis, Tennessee, 38119

  • Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226

    Milwaukee, Wisconsin, 53226

  • North Shore University Hospital /ID# 21022

    New Hyde Park, New York, 11040

  • Creighton Univ Med Ctr /ID# 11423

    Omaha, Nebraska, 68131

  • Methodist Medical Group Rheum /ID# 46343

    Peoria, Illinois, 61602

  • St. Christopher's Hospital /ID# 24385

    Philadelphia, Pennsylvania, 19134

  • AZ Arthritis and Rheumotology Research, PLLC /ID# 21023

    Phoenix, Arizona, 85032-9306

  • Legacy Emanuel Medical Center /ID# 14102

    Portland, Oregon, 97227

  • University of Rochester Medical Center /ID# 20967

    Rochester, New York, 14642

  • Scott & White Health Care /ID# 36762

    Round Rock, Texas, 78665

  • University of Utah /ID# 21041

    Salt Lake City, Utah, 84112-5500

  • Seattle Children's Hospital /ID# 20968

    Seattle, Washington, 98105

  • Catalina Pointe Clinical Research /ID# 40227

    Tucson, Arizona, 85704

  • New York Medical College /ID# 21964

    Valhalla, New York, 10595

  • Children's National Medical Center /ID# 23506

    Washington D.C., District of Columbia, 20010-2916

  • St. Barnabas Ambulatory Care /ID# 21025

    West Orange, New Jersey, 07052

Other trials in United States

France10 sites

  • Duplicate_CHU Bordeaux - Hopital Pellegrin /ID# 25454

    Bordeaux, Gironde, 33000

  • AP-HP - Hôpital Bicêtre /ID# 25443

    Le Kremlin-Bicêtre, 94270

  • CHRU Lille - Hopital Claude Huriez /ID# 25449

    Lille, Nord, 59037

  • Duplicate_AP-HP - Hopital Cochin /ID# 37345

    Paris, 75014

  • AP-HP - Hopital Necker /ID# 25442

    Paris, 75015

  • Duplicate_CHU de Rennes - Hospital Sud /ID# 27123

    Rennes, 35203

  • CHU Strasbourg - Hopital de Hautepierre /ID# 25450

    Strasbourg, Bas-Rhin, 67200

  • CHU Toulouse /ID# 37347

    Toulouse, Occitanie, 31300

  • CHRU Tours - Hopital Bretonneau /ID# 27126

    Tours, Indre-et-Loire, 37044

  • CHRU Nancy - Hopitaux de Brabois /ID# 25452

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Other trials in France

Germany10 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623

    Berlin, 10117

  • Helios Klinikum Berlin-Buch /ID# 37348

    Berlin, 13125

  • Klinikum Bremen Mitte /ID# 45942

    Bremen, 28205

  • Klinikum Dortmund gGmbH /ID# 44003

    Dortmund, 44137

  • Center Rheumatology Child&Adol /ID# 39069

    Garmisch-Patenkirchen, 82467

  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223

    Hamburg, 22081

  • Klinikum St. Georg gGmbH /ID# 37349

    Leipzig, 04129

  • Asklepios Klinik Sankt Augustin /ID# 41622

    Sankt Augustin, 53757

  • Universitaetsklinikum Tuebingen /ID# 39070

    Tübingen, Baden-Wurttemberg, 72076

  • Rheumazentrum Wedel /ID# 37350

    Wedel, 22880

Other trials in Germany

Italy10 sites

  • Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077

    Brescia, 25123

  • Duplicate_Universita di Catania /ID# 39075

    Catania, 95123

  • Ospedale Ss. Annunziata /ID# 37353

    Chieti, 66100

  • Azienda Ospedaliero Universitaria Meyer /ID# 26123

    Florence, Firenze, 50139

  • Istituto Giannina Gaslini /ID# 26668

    Genova, 16147

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124

    Milan, 20122

  • Azienda Ospedaliera Universitaria Federico II /ID# 39072

    Naples, 80131

  • Duplicate_Universita di Napoli Federico II /ID# 39078

    Naples, 80131

  • Fondazione IRCCS Policlinico /ID# 39076

    Pavia, 27100

  • IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074

    Rome, Roma, 00165

Other trials in Italy

Spain6 sites

  • Hospital Universitario Vall d'Hebron /ID# 37357

    Barcelona, 08035

  • Hospital Sant Joan de Deu /ID# 37358

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitario Severo Ochoa /ID# 41751

    Leganés, Madrid, 28911

  • Hospital Infantil Universitario Nino Jesus /ID# 37360

    Madrid, 28009

  • Hospital Universitario Ramon y Cajal /ID# 41624

    Madrid, 28034

  • Hospital Universitario y Politecnico La Fe /ID# 37359

    Valencia, 46026

Other trials in Spain

Austria4 sites

  • Landeskrankenhaus Bregenz /ID# 26128

    Bregenz, Vorarlberg, 6900

  • Medizinische Universitaet Graz /ID# 26126

    Graz, Styria, 8010

  • Duplicate_Kepler Universitaetsklinikum GmbH /ID# 39068

    Linz, Upper Austria, 4021

  • Medizinische Universitaet Wien /ID# 26127

    Vienna, State of Vienna, 1090

Other trials in Austria

Czechia4 sites

  • Fakultni Nemocnice Brno /ID# 37343

    Brno, 625 00

  • Revmatologicky ustav v Praze /ID# 43344

    Prague, 128 00

  • Vseobecna fakultni nemocnice v Praze /ID# 47401

    Prague, 128 08

  • Fakultni Nemocnice v Motole /ID# 37342

    Prague, 150 06

Other trials in Czechia

Portugal3 sites

  • Hospital Garcia de Orta, EPE /ID# 37355

    Almada, 2805-267

  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682

    Lisbon, 1649-035

  • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081

    Porto, 4099-001

Other trials in Portugal

Denmark2 sites

  • Aarhus University Hospital /ID# 25445

    Aarhus N, Central Jutland, 8200

  • Duplicate_Rigshospitalet, Finsen Centre /ID# 25444

    Copenhagen, 2100

Other trials in Denmark

Greece2 sites

  • Children's Hosp P. A. Kyriakou /ID# 25448

    Athens, Attica, 11527

  • General Hospital of Thessaloniki Hippokrateio /ID# 25447

    Thessaloniki, 54642

Other trials in Greece

Hungary2 sites

  • Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095

    Budapest, 1023

  • Debreceni Egyetem Klinikai Kozpont /ID# 95863

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

Puerto Rico2 sites

  • Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047

    Bayamón, 00959

  • Puerto Rico Children Hospital /ID# 47742

    Bayamón, 00960

Other trials in Puerto Rico

Australia1 site

  • Duplicate_Womens and Childrens Hospital /ID# 59182

    Adelaide, South Australia, 5006

Other trials in Australia

Netherlands1 site

  • Universitair Medisch Centrum Utrecht /ID# 48842

    Utrecht, 3584 CX

Other trials in Netherlands

Norway1 site

  • Oslo Universitetssykehus, Radiumhospitalet /ID# 46402

    Oslo, 0310

Other trials in Norway

Slovakia1 site

  • Narodny ustav reumatickych chorob /ID# 38102

    Piešťany, 921 12

Other trials in Slovakia

Sweden1 site

  • Queen Silvia Children's Hosp /ID# 26125

    Gothenburg, Västra Götaland County, 416 85

Other trials in Sweden

About this study

Official 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

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.

Read the detailed description

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.

Keywords
JIA, Juvenile Idiopathic Arthritis, Juvenile Arthritis, Polyarticular JIA, Polyarticular-course JIA
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adalimumabBiological

    Also called HUMIRA®

    As prescribed by treating physician

  • MethotrexateDrug

    Also called MTX

    As prescribed by treating physician

Study groups in NCT00783510
Study groupRoleWhat they receive
HUMIRA® Treatment ArmFor patients taking HUMIRA®
Receives: Biological: adalimumab
Methotrexate Treatment ArmFor patients taking Methotrexate
Receives: Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 10 years

  2. 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.

    Measured: Up to 10 years

Secondary outcomes (7)

  1. Pediatric American College of Rheumatology (PedACR) 50

    Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.

    Measured: Up to 10 years

  2. Pediatric American College of Rheumatology (PedACR) 70

    Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.

    Measured: Up to 10 years

  3. Pediatric American College of Rheumatology (PedACR) - 30

    Effectiveness data will be analyzed as observed and will be summarized for All the Treated Patient Population.

    Measured: Up to 10 years

  4. Child Health Questionnaire (CHQ-PF50)

    The results will be summarized at each visit and will be used in exploratory analyses.

    Measured: Assessed in months 1,3, 6 and every 6 months through Year 5

  5. Pediatric American College of Rheumatology (PedACR) 90

    Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.

    Measured: Up to 10 years

  6. 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.

    Measured: Assessed in months 1,3, 6 and every 6 months through Year 5

  7. Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ)

    Effectiveness of therapy through clinical assessment.

    Measured: Assessed in months 1,3, 6 and every 6 months through Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2008 (estimated)
  2. Study start11 Jul 2008
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
849 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00783510
Sponsor's protocol ID
P10-262
Acronym
STRIVE
Status last verified
Jan 2025
First submitted
28 Oct 2008
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Juvenile Idiopathic Arthritis and JIA, run by AbbVie at 92 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, France, Germany, Italy, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Serious Adverse Events (SAEs) (time frame: Up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00783510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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