Optimizing the treatment of psoriasis with methotrexate; after 40 years the first dose-finding study.

Phase 4

Withdrawn

Conditions: psoriasis
10014982

Registration Number: NL-OMON37246

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

-Patients over 18 years old
-Patients diagnosed with psoriasis
-Patients who the treating dermatologist finds eligible for starting methotrexate therapy

Exclusion Criteria

The exclusion criteria used are the contra-indications for treatment with MTX mentioned in the recently published Dutch guideline psoriasis:
-men and women who are trying to conceive
-pregnant or breastfeeding women
-alcohol-or drug abuse
-serious infections
-immunodeficiency
-bone-marrow dysfunction or haematological disorders
-serious liver- or kidney function disturbance
-a significantly low pulmonary function
-ulcus ventriculi or duodeni
-contra-indicated co-medication (hepatotoxic drugs like barbiturates, drugs that interfere with renal function like sulfomethoxazole, NSAID`s and penicilline or folic acid antagonists like trimethoprim.) ;Also patients with non plaque type psoriasis are excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the dose with the largest disease reduction (expressed in<br /><br>percentage of subjects who obtain a decline in PASI of 75% (*PASI 75)) compared<br /><br>to baseline at week 16 in the two different treatment groups; initiating with<br /><br>7.5 mg MTX once a week vs. 15 mg of MTX once a week. </p><br>

Secondary Outcome Measures