Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
NCT01421069
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
Exclusion criteria for subject planning to continue investigational product:
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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis | ||||||
Official Title ICMJE | AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014) | ||||||
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). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Juvenile Idiopahtic Arthritis | ||||||
Intervention ICMJE | Drug: etanercept
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. | ||||||
Study Arms ICMJE | Experimental: 1
Intervention: Drug: etanercept | ||||||
Publications * | Foeldvari I, Constantin T, Vojinovi? J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Su?i? G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dole?alová 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 109 | ||||||
Original Estimated Enrollment ICMJE | 100 | ||||||
Actual Study Completion Date ICMJE | February 4, 2021 | ||||||
Actual Primary Completion Date | February 4, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: 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. Exclusion Criteria: Exclusion criteria for subject planning to continue investigational product: 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. | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 2 Years to 30 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Colombia, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Slovenia, Spain | ||||||
Removed Location Countries | Czech Republic | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01421069 | ||||||
Other Study ID Numbers ICMJE | B1801023 0881A1-3342 ( Other Identifier: Alias Study Number ) 2010-023802-10 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |