Juvenile Idiopathic Arthritis (JIA) Registry

NCT00783510 | Completed

• 1 other identifier: P10-262
• Study Type: observational
• Target: 849
• Locations: 16 countries
• Sites: 91

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.

Conditions

Juvenile Idiopathic Arthritis; JIA

Keywords

JIA; Juvenile Idiopathic Arthritis; Juvenile Arthritis; Polyarticular JIA; Polyarticular-course JIA

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 10 years

• 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.

  Up to 10 years

Secondary Outcomes (7)

• Pediatric American College of Rheumatology (PedACR) 50

  Up to 10 years

• Pediatric American College of Rheumatology (PedACR) 70

  Up to 10 years

• Pediatric American College of Rheumatology (PedACR) - 30

  Up to 10 years

• Child Health Questionnaire (CHQ-PF50)

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

• Pediatric American College of Rheumatology (PedACR) 90

  Up to 10 years

Study Arms (2)

HUMIRA® Treatment Arm

For patients taking HUMIRA®

Biological: adalimumab

Methotrexate Treatment Arm

For patients taking Methotrexate

Drug: Methotrexate

Interventions

adalimumab BIOLOGICAL

As prescribed by treating physician

Also known as: HUMIRA®

HUMIRA® Treatment Arm

Methotrexate DRUG

As prescribed by treating physician

Also known as: MTX

Methotrexate Treatment Arm

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AbbVie: lead

Study Sites (92)

AZ Arthritis and Rheumotology Research, PLLC /ID# 21023

Phoenix, Arizona, 85032-9306, United States

Location

Catalina Pointe Clinical Research /ID# 40227

Tucson, Arizona, 85704, United States

Location

Arkansas Children's Hospital /ID# 23505

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Los Angeles /ID# 24386

Los Angeles, California, 90027, United States

Location

Children's National Medical Center /ID# 23506

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

Location

Duplicate_Arthritis Associates South FL /ID# 17001

Delray Beach, Florida, 33484, United States

Location

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

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medical Center /ID# 21981

Chicago, Illinois, 60637-1443, United States

Location

Methodist Medical Group Rheum /ID# 46343

Peoria, Illinois, 61602, United States

Location

Indiana University /ID# 11421

Indianapolis, Indiana, 46202, United States

Location

University of Louisville /ID# 23507

Louisville, Kentucky, 40202, United States

Location

Arthritis Care Spec. of MD /ID# 21961

Ellicott City, Maryland, 21042, United States

Location

Tufts Medical Center /ID# 21965

Boston, Massachusetts, 02111-1552, United States

Location

Creighton Univ Med Ctr /ID# 11423

Omaha, Nebraska, 68131, United States

Location

St. Barnabas Ambulatory Care /ID# 21025

West Orange, New Jersey, 07052, United States

Location

North Shore University Hospital /ID# 21022

New Hyde Park, New York, 11040, United States

Location

University of Rochester Medical Center /ID# 20967

Rochester, New York, 14642, United States

Location

New York Medical College /ID# 21964

Valhalla, New York, 10595, United States

Location

Duke Cancer Center /ID# 22904

Durham, North Carolina, 27710-3000, United States

Location

Bone Spine Sports/Medctr One /ID# 21962

Bismarck, North Dakota, 58501, United States

Location

Akron Children's Hospital /ID# 22907

Akron, Ohio, 44308, United States

Location

University of Cincinnati /ID# 14101

Cincinnati, Ohio, 45267-0585, United States

Location

Nationwide Children's Hospital /ID# 21963

Columbus, Ohio, 43205-2664, United States

Location

Legacy Emanuel Medical Center /ID# 14102

Portland, Oregon, 97227, United States

Location

St. Christopher's Hospital /ID# 24385

Philadelphia, Pennsylvania, 19134, United States

Location

Arthritis Associates of Kingsport /ID# 44462

Kingsport, Tennessee, 37660, United States

Location

Dr. Ramesh Gupta /ID# 45342

Memphis, Tennessee, 38119, United States

Location

Scott & White Health Care /ID# 36762

Round Rock, Texas, 78665, United States

Location

University of Utah /ID# 21041

Salt Lake City, Utah, 84112-5500, United States

Location

Children's Speciality Center /ID# 11503

Burlington, Vermont, 05401, United States

Location

Seattle Children's Hospital /ID# 20968

Seattle, Washington, 98105, United States

Location

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

Milwaukee, Wisconsin, 53226, United States

Location

Duplicate_Womens and Childrens Hospital /ID# 59182

Adelaide, South Australia, 5006, Australia

Location

Medizinische Universitaet Graz /ID# 26126

Graz, Styria, 8010, Austria

Location

Duplicate_Kepler Universitaetsklinikum GmbH /ID# 39068

Linz, Upper Austria, 4021, Austria

Location

Medizinische Universitaet Wien /ID# 26127

Vienna, Vienna, 1090, Austria

Location

Landeskrankenhaus Bregenz /ID# 26128

Bregenz, Vorarlberg, 6900, Austria

Location

Fakultni Nemocnice Brno /ID# 37343

Brno, 625 00, Czechia

Location

Revmatologicky ustav v Praze /ID# 43344

Prague, 128 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze /ID# 47401

Prague, 128 08, Czechia

Location

Fakultni Nemocnice v Motole /ID# 37342

Prague, 150 06, Czechia

Location

Aarhus University Hospital /ID# 25445

Aarhus N, Central Jutland, 8200, Denmark

Location

Duplicate_Rigshospitalet, Finsen Centre /ID# 25444

Copenhagen, 2100, Denmark

Location

CHU Strasbourg - Hopital de Hautepierre /ID# 25450

Strasbourg, Bas-Rhin, 67200, France

Location

Duplicate_CHU Bordeaux - Hopital Pellegrin /ID# 25454

Bordeaux, Gironde, 33000, France

Location

CHRU Tours - Hopital Bretonneau /ID# 27126

Tours, Indre-et-Loire, 37044, France

Location

CHRU Nancy - Hopitaux de Brabois /ID# 25452

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

Location

CHRU Lille - Hopital Claude Huriez /ID# 25449

Lille, Nord, 59037, France

Location

CHU Toulouse /ID# 37347

Toulouse, Occitanie, 31300, France

Location

AP-HP - Hôpital Bicêtre /ID# 25443

Le Kremlin-Bicêtre, 94270, France

Location

Duplicate_AP-HP - Hopital Cochin /ID# 37345

Paris, 75014, France

Location

AP-HP - Hopital Necker /ID# 25442

Paris, 75015, France

Location

Duplicate_CHU de Rennes - Hospital Sud /ID# 27123

Rennes, 35203, France

Location

Universitaetsklinikum Tuebingen /ID# 39070

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623

Berlin, 10117, Germany

Location

Helios Klinikum Berlin-Buch /ID# 37348

Berlin, 13125, Germany

Location

Klinikum Bremen Mitte /ID# 45942

Bremen, 28205, Germany

Location

Klinikum Dortmund gGmbH /ID# 44003

Dortmund, 44137, Germany

Location

Center Rheumatology Child&Adol /ID# 39069

Garmisch-Patenkirchen, 82467, Germany

Location

Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223

Hamburg, 22081, Germany

Location

Klinikum St. Georg gGmbH /ID# 37349

Leipzig, 04129, Germany

Location

Asklepios Klinik Sankt Augustin /ID# 41622

Sankt Augustin, 53757, Germany

Location

Rheumazentrum Wedel /ID# 37350

Wedel, 22880, Germany

Location

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

Athens, Attica, 11527, Greece

Location

General Hospital of Thessaloniki Hippokrateio /ID# 25447

Thessaloniki, 54642, Greece

Location

Debreceni Egyetem Klinikai Kozpont /ID# 95863

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095

Budapest, 1023, Hungary

Location

Azienda Ospedaliero Universitaria Meyer /ID# 26123

Florence, Firenze, 50139, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074

Rome, Roma, 00165, Italy

Location

Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077

Brescia, 25123, Italy

Location

Duplicate_Universita di Catania /ID# 39075

Catania, 95123, Italy

Location

Ospedale Ss. Annunziata /ID# 37353

Chieti, 66100, Italy

Location

Istituto Giannina Gaslini /ID# 26668

Genova, 16147, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124

Milan, 20122, Italy

Location

Duplicate_Universita di Napoli Federico II /ID# 39078

Naples, 80131, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 39072

Napoli, 80131, Italy

Location

Fondazione IRCCS Policlinico /ID# 39076

Pavia, 27100, Italy

Location

Universitair Medisch Centrum Utrecht /ID# 48842

Utrecht, 3584 CX, Netherlands

Location

Oslo Universitetssykehus, Radiumhospitalet /ID# 46402

Oslo, 0310, Norway

Location

Hospital Garcia de Orta, EPE /ID# 37355

Almada, 2805-267, Portugal

Location

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

Lisbon, 1649-035, Portugal

Location

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

Porto, 4099-001, Portugal

Location

Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047

Bayamón, 00959, Puerto Rico

Location

Puerto Rico Children Hospital /ID# 47742

Bayamón, 00960, Puerto Rico

Location

Narodny ustav reumatickych chorob /ID# 38102

Piešťany, 921 12, Slovakia

Location

Hospital Sant Joan de Deu /ID# 37358

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitario Severo Ochoa /ID# 41751

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 37357

Barcelona, 08035, Spain

Location

Hospital Infantil Universitario Nino Jesus /ID# 37360

Madrid, 28009, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 41624

Madrid, 28034, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 37359

Valencia, 46026, Spain

Location

Queen Silvia Children's Hosp /ID# 26125

Gothenburg, Västra Götaland County, 416 85, Sweden

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Adalimumab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 31, 2008
• Study Start: July 11, 2008
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

IT (10); AU (4); SL (1); DE (10); GR (2); FR (10); ES (6); NO (1); PR (2); HU (2); US (32); PT (3); SE (1); CZ (4); DK (2); NL (1)