Comparison of efficacy, safety and costs of outpatient biological treatment for psoriasis in daily clinical practice.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015099-86-NL

Enrollment

200

Registered

2009-08-25

Start date

2009-12-02

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Psoriasis MedDRA version: 12.0 Level: LLT Classification code 10037153 Term: Psoriasis

Interventions

Trade Name: Humira Pharmaceutical Form: Solution for injection Trade Name: Humira Pharmaceutical Form: Solution for injection Trade Name: Enbrel Pharmaceutical Form: Solution for injection Trade Na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must be 18 years or older. 2. Patients must fulfill the criteria for biological treatment of the Dutch Society of Dermatology and Venereology and the criteria for reimbursement. They must have a PASI of 10 or higher, or a PASI of 8 or higher in combination with a Skindex-29 > 35 at the time of screening and must have failed to respond to phototherapy and cyclosporin or methotrexate, or have a contraindication to or an intolerance for these treatments. 3. Patients must be willing to give written informed consent and be able to adhere to dose and visit schedules. 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: Contra-indications: 1. Hypersensitivity to the active substance or to any of the excipients. 2. Sepsis or risk of sepsis. 3. Active infections including chronic or localised infections. 4. Immunocompromised persons and patients treated with immunosuppressive drugs. 5. Patients with a history of a demyelinating disease. 6. Patients with a history of tuberculosis. 7. Pregnancy. Relative contraindications: 1. Congestive heart failure. 2. Blood dyscrasias. 3. Recent malignancies. 4. Antinuclear antibody (ANA)-positive autoimmune diseases. 5. Chronic exposure to actinic radiation in the past. 6. Possible tuberculosis infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: To prospectively compare the effectiveness of two biological therapies for patients with psoriasis in daily clinical practice: etanercept and adalimumab. ;Secondary Objective: To prospectively compare the safety and costs of two biological therapies for patients with psoriasis in daily clinical practice: etanercept and adalimumab. ;Primary end point(s): The main study endpoint is the percentage of patients with a reduction of the PASI of at least 50% after 3 months. Primary endpoints of the economic evaluation are costs, proportion relevant reduction in PASI (PASI 50) and QALYs (measured with the EQ-5D).	—

Measure

Time frame

Main Objective: To prospectively compare the effectiveness of two biological therapies for patients with psoriasis in daily clinical practice: etanercept and adalimumab. ;Secondary Objective: To prospectively compare the safety and costs of two biological therapies for patients with psoriasis in daily clinical practice: etanercept and adalimumab. ;Primary end point(s): The main study endpoint is the percentage of patients with a reduction of the PASI of at least 50% after 3 months. Primary endpoints of the economic evaluation are costs, proportion relevant reduction in PASI (PASI 50) and QALYs (measured with the EQ-5D).

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Countries

Netherlands

Outcome results

None listed

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