Safety and efficacy of efalizumab in combination with methotrexate in patients with severe psoriasis: a comparative study.

Phase 1

Active, not recruiting

• Conditions: Moderate to severe chronic plaque psoriasis; MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2007-001630-14-NL
• Lead Sponsor: niversity Medical Centre St. Radboud, Department of Dermatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients must be ³ 18 years of age.
2. Patients must have a diagnosis of moderate to severe chronic plaque psoriasis.
3. Patients must have a PASI ³ 10, or a PASI ³ 8 in combination with a Skindex-29 16 > 35.
4. Patients must have failed to respond to phototherapy, methotrexate and/or cyclosporin in the past or have a contraindication for using phototherapy or cyclosporin.
5. Patients must be free of any clinically significant disease (other than psoriasis) that would interfere with the study evaluations.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have non-plaque forms of psoriasis as the dominant form of psoriasis (e.g., erythrodermic, guttate or pustular).
2. Patients who have current drug-induced psoriasis.
3. Female patients who are pregnant, nursing and both men and women who are planning pregnancy during the study period or during the six months after receiving the last dose of study medication.
4. Patients who have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and efficacy of efalizumab combined with methotrexate compared with efalizumab monotherapy in adult patients with moderate to severe chronic plaque psoriasis.;Secondary Objective: ;Primary end point(s): The primary endpoint for the study is the number and nature of adverse events in both treatment arms, representing treatment safety.