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"PSOGEN:Effect adalimumab op zelfbeeld en seksueel functioneren bij matige en ernstige psoriasis van de anogenitale regio; prospectief, open label pilot onderzoek" - PSOGEN

"PSOGEN:Effect adalimumab op zelfbeeld en seksueel functioneren bij matige en ernstige psoriasis van de anogenitale regio; prospectief, open label pilot onderzoek" - PSOGEN

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011625-13-NL
Enrollment
20
Registered
2009-04-24
Start date
2009-10-05
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Anogenital Psoriasis MedDRA version: 1 Level: LLT Classification code 10016776 Term:

Interventions

Trade Name: Humira Product Name: Humira Pharmaceutical Form: Injection* INN or Proposed INN: adalimumab CAS Number: 331731-18-1 Current Sponsor code: ABT-D2E7 Other descriptive name: humira Concentrat

Sponsors

Abbott
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient has moderate to severe anogenital psoriasis. Patient is over 18 years old. Patient is heterosexual. Treatment with adalimumab is to be started by attending dermatologist. 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient is unwilling to participate. Patient is homosexual. Patient is younger than 18 years.

Design outcomes

Primary

MeasureTime frame
Main Objective: To asses the effect of improvement of anogenital psoriasis on sexual function in patients treated with adalimumab.;Secondary Objective: To assess the psychosexual problems in a population of patients with anogenital psoriasis.;Primary end point(s): Reduction of PASI and questionnare scores. Reduction of scores in questionnares: -Skindex -PASI -SEAR -IIEF -FSF -HADS

Countries

Netherlands

Outcome results

None listed

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