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

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of combined ETN and MTX treatment and of ETN treatment alone as measured by the proportion of patients whose active psoriatic disease is judged to be cleared or almost cleared on the PGA (Physician's Global Assessment of psoriasis) after 24 weeks of treatment.;Secondary Objective: To evaluate the efficacy of ETN + MTX and ETN as measured by:<br>- Percentage improvement in PASI (Psoriasis Area and Severity Index) and proportion of patients demonstrating PASI 50, PASI 75 and PASI 90 response<br>- Time to clear or almost clear on PGA (Physician's Global Asessment of psoriasis)<br>- Patient Global Assessment of psoriasis<br>- The Dermatology Life Quality Index (DLQI)<br>- The Euro QOL 5D Feeling Thermometer<br>- The proportion of patients who discontinue due to adverse effects<br>- Change in topicals<br>- Pharmacoeconomic analysis ;Primary end point(s): The proportion of patients who are cleared or almost cleared on the PGA (Physicians Global Assessment) at 24 weeks.

Secondary Outcome Measures

Name	Time	Method

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