CompletedPhase 3

Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Australia, Belgium, Colombia109 participantsStarted 2011-10-10

Plain-language 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).

Who can participate

Age range2 Years – 30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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)

Trial details

NCT IDNCT01421069

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-04

Results submitted2022-01-13