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Study Complete

Sponsor ID

20030211

Etanercept (Enbrel®) in Psoriasis - Pediatrics

Sponsor ID

20030211

Clinicaltrials.gov ID

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.

Additional Study Details

Phase

Phase 3

Product

etanercept

Type

Interventional

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment

211

Additional Study Details

Protocol Summary

Primary Outcome Measures

PASI (Psoriasis Area and Severity Index) 75 response at week 12, defined as a 75% or greater decrease in PASI score (i.e., improvement) from baseline at week 12.

Timeframe: 12 weeks

Secondary Outcome Measures

PASI 50 response at week 12

Timeframe: 12 Weeks

PASI 90 response at week 12

Timeframe: 12 weeks

Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12

Timeframe: 12 weeks

Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12

Timeframe: 12 weeks

Safety as measured by adverse events, infections, injection site reaction, lab toxicity, vital signs, antibodies to etanercept, and disease rebound during the investigational product withdrawal period

Timeframe: 48 weeks

Pharmacokinetics

Timeframe: 48 weeks

Study Documents

Study Synopsis

Available Language(s): English

Download Document(s)

Locations

No locations found.