psoriasis
Conditions
Interventions
One group will start with 7.5 mg MTX once a week, the other with 15 mg MTX once
a week. Doses will be increased or decreased based upon clinical improvement,
with a maximum of 25 mg once a week. Bot
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Patients over 18 years old -Patients diagnosed with psoriasis -Patients who the treating dermatologist finds eligible for starting methotrexate therapy
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the dose with the largest disease reduction (expressed in percentage of subjects who obtain a decline in PASI of 75% (*PASI 75)) compared to baseline at week 16 in the two different treatment groups; initiating with 7.5 mg MTX once a week vs. 15 mg of MTX once a week. | — |
Secondary
| Measure | Time frame |
|---|---|
| -To compare the disease reduction expressed in *PASI 75 compared to baseline at weeks 4, 8, 28, 40 and 52 in the two treatment groups. -To compare disease reduction of nail involvement expressed in *NAPSI compared to baseline at weeks 8, 16, 28, 40 and 52 in the two treatment groups. -To compare the disease reduction expressed in IGA and PGA compared to baseline at weeks 8, 16, 28, 40 and 52 in the two treatment groups. -To compare the quality of life (measured by Skindex-29 questionnaire and DLQI) compared to baseline at weeks 4, 8, 16, 28, 40 and 52 in the two treatment groups. -To monitor the side effects of MTX in the two different treatment groups. This will be done by standard questionnaires and blood sampling. For measuring hepatotoxicity we include transaminase screening, PIIINP and fibroscan. Fibroscan is included because the disputable value of PIIINP, especially in patients with psoriatic arthritis. | — |
Countries
Netherlands
Outcome results
None listed