A multicenter, open-label, randomized, pilot study to evaluate the efficacy and safety of the combination of etanercept (ETN) and methotrexate and of etanercept (ETN) alone in patients with active plaque psoriasis despite methotrexate therapy

• Conditions: Plaque psoriasis

• Registration Number: EUCTR2004-004201-18-SE
• Lead Sponsor: Wyeth Lederle Nordiska AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Active plaque psoriasis involving =10% of the body surface area (BSA) and/or a minimal screening PASI score of 8.
2. MTX at a dose of minimum 7.5 mg/week for the last 3 months.
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. Predominantly guttate, erythrodermic, or pustular psoriasis.
2. Clear or almost clear on PGA (Phycians Global Assessment).
3. Previous receipt of any TNF-inhibitor, including etanercept.
4. Skin conditions (e.g. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
6. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, acitretin, alefacept (Amevive) and efalizumab (Raptiva) or any other systemic psoriasis therapy (exception: methotrexate) within 4 weeks of study drug initiation.
7. Systemic corticosteroids within 4 weeks prior to study drug initiation.
8. Ultraviolet light B (UVB), topical steroids group III and IV, topical Vitamin A or D analog preparations, or anthralin within 2 weeks prior to study drug initiation.
9. Tar compounds (except tar shampoo) within 4 weeks prior to study drug initiation.
10. Significant concurrent medical diseases including:
· Diabetes mellitus requiring insulin
· Uncompensated congestive heart failure
· Myocardial infarction within 12 months of screening visit
· Unstable angina pectoris
· Uncontrolled hypertension
· Severe pulmonary disease
· Patients with systemic lupus erythematosus or history of multiple sclerosis or any other demyelinating disease
· History of cancer (other than resected cutaneous basal and squamos cell carcinoma, and in situ cervical cancer) within 5 years of baseline visit
· Known HIV positive, hepatis BsAg, or hepatitis C positive
· Any condition judged by the patient’s physician that would cause this study to be detrimental to the patient.

Study & Design

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