Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

NCT00962741 | Completed Phase 3 Results DMC

• 2 other identifiers: 0881A1-3338B1801014
• Study Type: interventional
• Target: 127
• Locations: 18 countries
• Sites: 41

Brief Summary

This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.

Conditions

Arthritis, Juvenile Idiopathic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12

  ACR Pedi 30 response: greater than or equal to (\>=) 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.

  Week 12

Secondary Outcomes (56)

• Percentage of Participants With an ACR Pedi 30 Response

  Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population

  Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population

  Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population

  Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Percentage of Participants With an ACR Pedi 50 Response

  Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Other Outcomes (31)

• Tender Entheseal Assessment for ERA Sub-population

  Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Overall Back Pain Score for ERA Sub-population

  Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

• Nocturnal Back Pain Score for ERA Sub-population

  Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Study Arms (1)

1

EXPERIMENTAL

Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Drug: Etanercept

Interventions

Etanercept DRUG

Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Also known as: Enbrel

1

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects with a diagnosis per International League of Associations for Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and 17 years.
• \>= 2 active joints and the following for the relevant JIA subtype: extended oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response to a disease modifying antirheumatic drug (DMARD); or ERA with a history of intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug (NSAID) or a DMARD.

You may not qualify if:

• Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria.
• Other rheumatic diseases.
• Active uveitis within 6 months of the baseline visit.
• Any other significant health problem.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (42)

Pfizer Investigational Site

Westmead, Sydney, New South Wales, 2145, Australia

Location

Pfizer Investigational Site

Parkville, Melbourne, Victoria, 3052, Australia

Location

Pfizer Investigational Site

Ghent, Belgium, 9000, Belgium

Location

Pfizer Investigational Site

Brussels, 1200, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Barranquilla, Atlántico, Colombia

Location

Pfizer Investigational Site

Bogota, Cundinamarca, 0000, Colombia

Location

Pfizer Investigational Site

Bucaramanga, Santander Department, Colombia

Location

Pfizer Investigational Site

Brno, 625 00, Czechia

Location

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Prague, 121 00, Czechia

Location

Pfizer Investigational Site

Prague, 128 50, Czechia

Location

Pfizer Investigational Site

Le Kremlin-Bicêtre, 92470, France

Location

Pfizer Investigational Site

Paris, 75015, France

Location

Pfizer Investigational Site

Paris, 75674, France

Location

Pfizer Investigational Site

Berlin, 13125, Germany

Location

Pfizer Investigational Site

Bremen, 28177, Germany

Location

Pfizer Investigational Site

Hamburg, 22081, Germany

Location

Pfizer Investigational Site

Hanover, 30625, Germany

Location

Pfizer Investigational Site

Sankt Augustin, 53757, Germany

Location

Pfizer Investigational Site

Budapest, 1094, Hungary

Location

Pfizer Investigational Site

Chieti, 66013, Italy

Location

Pfizer Investigational Site

Riga, 1079, Latvia

Location

Pfizer Investigational Site

Riga, LV1004, Latvia

Location

Pfizer Investigational Site

Vilnius, LT 2600, Lithuania

Location

Pfizer Investigational Site

Mexico City, Mexico City, 06700, Mexico

Location

Pfizer Investigational Site

Utrecht, 3584 EA, Netherlands

Location

Pfizer Investigational Site

Oslo, 0027, Norway

Location

Pfizer Investigational Site

Krakow, Poland, 31-503, Poland

Location

Pfizer Investigational Site

Wroclaw, Poland, 52-114, Poland

Location

Pfizer Investigational Site

Bydgoszcz, 85-667, Poland

Location

Pfizer Investigational Site

Warsaw, 02-673, Poland

Location

Pfizer Investigational Site

Moscow, 115522, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194100, Russia

Location

Pfizer Investigational Site

Belgrade, Serbia, 11000, Serbia

Location

Pfizer Investigational Site

Niš, 18000, Serbia

Location

Pfizer Investigational Site

Košice, 040 01, Slovakia

Location

Pfizer Investigational Site

Piešťany, 921 12, Slovakia

Location

Pfizer Investigational Site

Ljubljana, 1000, Slovenia

Location

Pfizer Investigational Site

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28034, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

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, Juvenile

Interventions

Etanercept

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)

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

Limitations and Caveats

Results include data for Part 1 (up to Week 12) and Part 2 (up to week 96) of the study.

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 20, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: January 1, 2013
• Last Updated: June 10, 2014
• Results First Posted: July 19, 2012

Record last verified: 2014-05

Locations

SL (2); ES (4); CO (3); NO (1); RU (2); DE (5); FR (3); ME (1); CZ (3); BE (3); NL (1); PL (4); IT (1); LI (1); LA (2); HU (1); AU (2); SE (2)