Effectiveness and safety of biological drugs in psoriasis

Phase 1

• Conditions: Moderate to severe psoriasis and joint disease; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-001695-26-IT
• Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

both sexes, aged 18-75, affected by moderate to severe psoriasis eligible to systemic treatment with biologic drugs (etanercept, stelara), either as first line therapy or after three months of wash out will be enrolled in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

Breast feeding women
Women planning a pregnancy
History of cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified