A pilot trial of noninvasive assessment of methotrexate hepatotoxicity in the course of pharmacokinetically guided pharmacotherapy of psoriasis with methotrexate and folic acid

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015403-95-CZ

Enrollment

Registered

2009-10-07

Start date

2010-02-11

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate-severe and severe plaque psoriasis

Interventions

Trade Name: ACIDUM FOLICUM LECIVA Product Name: ACIDUM FOLICUM LECIVA Pharmaceutical Form: Coated tablet INN or Proposed INN: FOLIC ACID CAS Number: 59303 Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: A prospective, two-year study will be conducted which consists of 1/ an initial pharmacokinetic study aimed to individualize dosing of methotrexate, and 2/ a 2-year period of regular visits to closely monitor MTX and folate in erythrocytes, to perform individual tailoring of long-term MTX therapy including folate supplementation with folic acid, and to monitor blood chemistry (the noninvasive bioindicators of hepatotoxicity) and haematology, and skin status (the PASI-score). The results of the project will help to formulate a suitable strategy for dosing of MTX and folic acid during the long-term treatment of psoriasis using the pharmacokinetic approach, i.e. monitoring of both MTX and folate levels in erythrocytes and individual tailoring of dosing of both drugs. ;Secondary Objective: Furthermore, noninvasive biochemical markers of hepatotoxicity will be followed during this innovative therapy and results compared to patients A/ who tolerate well long-term MTX pharmacotherapy, and B/ who are treated with biologic drugs. ;Primary end point(s): - changes in the concentrations of noninvasive bioindicators of hepatotoxicity (Fibrotest, hyaluronic acid, aminoterminal peptide of procolagen III) - skin status (the PASI score)	—

Measure

Time frame

Main Objective: A prospective, two-year study will be conducted which consists of 1/ an initial pharmacokinetic study aimed to individualize dosing of methotrexate, and 2/ a 2-year period of regular visits to closely monitor MTX and folate in erythrocytes, to perform individual tailoring of long-term MTX therapy including folate supplementation with folic acid, and to monitor blood chemistry (the noninvasive bioindicators of hepatotoxicity) and haematology, and skin status (the PASI-score). The results of the project will help to formulate a suitable strategy for dosing of MTX and folic acid during the long-term treatment of psoriasis using the pharmacokinetic approach, i.e. monitoring of both MTX and folate levels in erythrocytes and individual tailoring of dosing of both drugs. ;Secondary Objective: Furthermore, noninvasive biochemical markers of hepatotoxicity will be followed during this innovative therapy and results compared to patients A/ who tolerate well long-term MTX pharmacotherapy, and B/ who are treated with biologic drugs. ;Primary end point(s): - changes in the concentrations of noninvasive bioindicators of hepatotoxicity (Fibrotest, hyaluronic acid, aminoterminal peptide of procolagen III) - skin status (the PASI score)

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026