N/A
ID
Bron
Verkorte titel
Aandoening
Psoriasis vulgaris
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
PASI-score
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
N/A
Onderzoeksproduct en/of interventie
Randomization in two groups. One patient group will receive fumarate therapy combined with levocetirizine.
The other patient group will receive fumarate therapy combined with a placebo instead of levocetirizine.
Publiek
Dermatology Department
P.O. Box 2040
S. Fallah-Arani
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4639222
s.fallaharani@erasmusmc.nl
Wetenschappelijk
Dermatology Department
P.O. Box 2040
S. Fallah-Arani
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4639222
s.fallaharani@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with known severe psoriasis of the chronic plaque type
2. PASI > 10
3. Age > 18 years
4. Psoriasis therapies cannot be administered starting from 28 days before baseline visit until discontinuation of the study medications at the end of the study.
5. All forms of ultraviolet light therapy are prohibited during the study through week 12, such as PUVA and UVB (including narrow band UVB and excimer laser). Puva is prohibited starting from 28 days before the baseline and UVB is prohibited starting from 14 days before baseline.
6. All forms of topical psoriasis therapies cannot be administered from 14 days before baseline until discontinuation of the study medications through week 12.
7. Investigational or biological drugs are not permitted from 28 days prior to screening visit until discontinuation of the study medication at the end of study.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnancy and breast feeding
2. Patients with Prostate hyperplasia, Glaucoma, Stomach ulcer
3. Patients with liver diseases
4. Patients with kidney diseases
5. Patients with blood test deviations
6. Patients with gastro-intestinal diseases
7. Patients with a history of malignancies
8. Presence of clinically significant renal and hepatic laboratory values ( i.e.,male patients with serum creatinine ¡Ý 133 umol/L; female patients with serum creatinine ¡Ý 124 umol/L; ALT, AST, total bilirubin, GGT, or Alkaline Phosphatase > 2.5 times the upper limit of the reference range).
9. Serum lipase impairments (total cholesterol > 6.5 mmol/l, LDL-cholesterol > 2mmol/l, triglyceride > 3 mmol/l).
10. Hemoglobin parameters must satisfy the following criteria:
10.1 hemoglobin < 7.5 mmol/l
10.2 leukocytes > 3.50*10E9/l and < 10*10E9/l
10.3 lymphocytes > 15% and < 50% of the total white cell count.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL734 |
NTR-old | NTR744 |
Ander register | : N/A |
ISRCTN | ISRCTN12758639 |