FindTrial
Sign In

A multi-center, open-label trial evaluating the Efficacy, Safety and the Impact on Quality of Life of Infliximab Therapy in patients with moderate to severe psoriasis not responding and/or intolerant to systemic standard or biologic therapy - ESAQUALITY. - ESAQUALITY

A multi-center, open-label trial evaluating the Efficacy, Safety and the Impact on Quality of Life of Infliximab Therapy in patients with moderate to severe psoriasis not responding and/or intolerant to systemic standard or biologic therapy - ESAQUALITY. - ESAQUALITY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004465-41-IT
Enrollment
Unknown
Registered
2006-03-14
Start date
2006-01-27
Completion date
Unknown
Last updated
2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe psoriasis. MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: REMICADE*EV F 100MG+F 2ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Infliximab CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentrati

Sponsors

SCHERING-PLOUGH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients must be 1.5 mg/dL AST, ALT, alkaline phosphatase and gamma-glutamyltransferase >= x upper normal limit of normal range for the laboratory conducting the test. Patients must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that could interfere with the study evaluation. Patients must be willing to give written informed consent and be able to adhere to protocol visit and procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Standard concomitant psoriasis therapies. - Active or latent TB. - History of chronic infectious disease, opportunistic infection or serious infection within 2 months of enrollment. - History of lymphoproliferative disease. - Malignancy in past 5 years (except treated BCC). - Treatment with TNF antagonist within previous 12 weeks or other experimental drugs within previous 4 weeks. - Patients who have current-drug induced psoriasis. - Female patients who are pregnant or nursing. Patients previously treated with Infliximab. - Patients who have a concomitant diagnosis of CHF.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective is to assess the efficacy (PASI 75) of IFX (5 mg/kg) in adult subjects (aged 18 to 75 years) with moderate to severe chronic psoriasis not responding and/or intollerant to systemic standard or biologic therapies.;Secondary Objective: To evaluate the safety, efficacy (PASI 50, 90, BSA, SAPASI) and the impact on QOL (SF-36, EQ-5D, SKINDEX 29, Itch Measure VAS) of IFX.;Primary end point(s): PASI 75 response rate at week 10 will be evaluated. PASI 75 will be summarized by counts and percentages. The PASI 75 response rate will be estimated and its 95% Confidence Interval will be calculated.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026