A pilot trial of noninvasive assessment of methotrexate hepatotoxicity in the course of pharmacokinetically guided pharmacotherapy of psoriasis with methotrexate and folic acid
- Conditions
- moderate-severe and severe plaque psoriasis
- Registration Number
- EUCTR2009-015403-95-CZ
- Lead Sponsor
- Faculty Hospital Hradec Králové
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
- patients with moderate-severe or severe psoriasis requiring systemic immunosuppressive therapy
- patients had never received MTX or had not been taking MTX for at least 6 months preceding the study
- results of the laboratory tests without clinically significant alterations: Blood count (Hb, Hct, erythrocytes, leukocytes, differential blood count, platelets), Liver tests (ALT, AST, AP, g GT, albumin bilirubin), Creatinine/Urea, Urine sediment
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
• Desire to have children (for both men and women)
• Pregnancy and nursing
• Inadequate contraception
• Drug abuse
• Alcoholism
• Known sensitivity to active ingredient methotrexate (e.g. pulmonary toxicity)
• Dysfunction of the bone marrow
• Severe liver disease
• Severe infections
• Immunodeficiency
• Active peptic ulcer
• Hematologic changes (leukopenia, thrombocytopenia, anemia)
• Renal failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method