Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

AbbVie

Status: Completed

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT01155570

P12-077

Details and patient eligibility

About

The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:

• unknown adverse drug reactions, especially clinically significant adverse reactions
• incidence and conditions of occurrence of adverse reactions in the clinical setting
• factors that may affect the safety and effectiveness of Humira.

Full description

This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice.

When investigators prescribed Humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. At the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. Even if Humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of Humira, and filled out a case report form for the participant at the end of the 24-week period.

Some participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.

Enrollment: 752 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be

• those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or
• patients with intractable eruptions of joint signs/symptoms.

Exclusion criteria

Contraindications according to the Package Insert include patients who have any of the following:

• serious infections
• tuberculosis
• a history of hypersensitivity to any ingredient of Humira
• demyelinating disease or a history of demyelinating disease
• congestive cardiac failure.

Trial design

752 participants in 1 patient group

Humira

Description:

Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.