Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

NCT01421069 | Completed Phase 3 Results DMC

• 3 other identifiers: B18010230881A1-33422010-023802-10
• Study Type: interventional
• Target: 109
• Locations: 18 countries
• Sites: 34

Brief Summary

This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) \[extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)\] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).

Conditions

Juvenile Idiopahtic Arthritis

Keywords

Use of etanercept to treat pediatric subjects with extended oligoarticular JIA; enthestitis related arthritis (ERA); or psoriatic arthritis (PsA).

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Malignancy: All Periods of Parent and Extension Study

  Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

  First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Secondary Outcomes (79)

• Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study

  First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

• Number of Participants With Serious Infections: All Periods of Parent and Extension Study

  First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

• Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study

  First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

• Number of Participants With Infections: All Periods of Parent and Extension Study

  First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

• Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study

  Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)

Study Arms (1)

1

EXPERIMENTAL

Drug: etanercept

Interventions

etanercept DRUG

Subjects aged \<18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW). Subjects aged greater than or equal to 18 years or \>62 kg will receive etanercept SC at a dose of 50 mg QW.

1

Eligibility Criteria

• Age: 2 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)
• Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.

You may not qualify if:

• withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).
• History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (35)

The Children's Hospital at Westmead

Westmead, Sydney, New South Wales, 2145, Australia

Location

Royal Children's Hospital

Parkville, Melbourne, Victoria, 3052, Australia

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Servimed S.A.S

Bucaramanga, Santander Department, 680003, Colombia

Location

Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie

Brno, 61300, Czechia

Location

Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze

Prague, 121 00, Czechia

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital NECKER-Enfants Malades

Paris, 75015, France

Location

HELIOS Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Klinikum Bremen-Mitte

Bremen, 28177, Germany

Location

Schön Klinik Hamburg Eilbek

Hamburg, 22081, Germany

Location

Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie

Saint Augustin, 53757, Germany

Location

Semmelweis Egyetem

Budapest, 1094, Hungary

Location

Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"

Chieti Scalo, 66013, Italy

Location

University Children Hospital Gailezers

Riga, 1079, Latvia

Location

University Children Hospital

Riga, LV1004, Latvia

Location

Children's Hospital at Vilnius University Hospital "Santaros klinikos"

Vilnius, 08406, Lithuania

Location

CLIDITER S.A. de C.V.

México, D.F., 06700, Mexico

Location

Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063

Utrecht, 3584 EA, Netherlands

Location

Depart. of Rheumatology

Oslo, 0027, Norway

Location

Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego

Bydgoszcz, 85-667, Poland

Location

Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,

Krakow, 31-503, Poland

Location

Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i

Warsaw, 02-637, Poland

Location

Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny

Wroclaw, 52-114, Poland

Location

FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy

Moscow, 115522, Russia

Location

SBEI HPE Saint Petersburg State Pediatric Medical University

Saint Petersburg, 194100, Russia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Children's Clinic of Internal Medicine

Niš, 18000, Serbia

Location

Narodny ustav reumatickych chorob

Piešťany, 921 12, Slovakia

Location

University Medical Centre Ljubljana, University Children's Hospital

Ljubljana, 1000, Slovenia

Location

Hospital San Juan de Dios

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Related Publications (2)

• Vojinovic J, Foeldvari I, Dehoorne J, Panaviene V, Susic G, Horneff G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Akikusa J, Avcin T, Borlenghi C, Arthur E, Tatulych SY, Zang C, Tsekouras V, Vlahos B, Martini A, Ruperto N. Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis. Rheumatology (Oxford). 2024 Jan 4;63(1):140-148. doi: 10.1093/rheumatology/kead183.

  PMID: 37140539 DERIVED

• Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

  PMID: 31122296 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Psoriatic; Salivary Gland Adenoma, Pleomorphic

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 22, 2011
• Study Start: October 10, 2011
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); CZ (3); LI (1); NL (1); ME (1); LA (2); HU (1); ES (3); PL (4); FR (2); CO (1); NO (1); DE (4); SE (2); BE (2); IT (1); RU (2); SL (1)