Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept (ReSPONSE)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992394

B1801021 (Other Identifier)

2008-004439-39 (EudraCT Number)

0881X1-4535

Details and patient eligibility

About

This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eighteen (18) years of age or older at the time of consent.
• Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks prior to the screening visit and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit
• Having shown clinical response with a PGA inferior or equal to 1 at the screening visit.
• PGA inferior or equal to 1 at the baseline visit.

Exclusion criteria

• Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
• Evidence of active or previously known medical history of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).
• Any biologics other than etanercept within the 20 weeks prior to the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Arm 1

Other group

Description:

Subjects randomized to arm 1 stop their etanercept treatment on entry into the study and may be retreated by etanercept 50 mg once weekly after medical review and agreement between the subject and the investigator

Treatment:

Drug: etanercept

Drug: etanercept

Arm 2

Other group

Description:

Subjects randomized to arm 2 in which subjects continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the subject and the investigator

Treatment:

Drug: etanercept

Drug: etanercept