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Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

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Amgen

Status and phase

Completed
Phase 3

Conditions

Psoriasis

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00111436
20030115

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.

Enrollment

912 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)

Exclusion criteria

  • Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
  • Pregnant or breast-feeding females
  • Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

912 participants in 2 patient groups

50 mg
Experimental group
Description:
50 mg once weekly
Treatment:
Drug: Etanercept
100 mg
Experimental group
Description:
50 mg twice weekly
Treatment:
Drug: Etanercept

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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