Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)

AbbVie

Status: Completed

Conditions: Psoriatic Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01559038

P12-666

Details and patient eligibility

About

The current study will assess the real - life effectiveness of adalimumab in the management of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis (PsA).

Enrollment: 483 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult >= 18 years old
• Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
• Active Psoriatic Arthritis (PsA) with three (3) or more tender and swollen joints as well as active psoriatic skin lesions or confirmed history of psoriasis
• Inadequate response or non-tolerant to current disease-modifying antirheumatic drugs (DMARD) based treatment for PsA

Exclusion criteria

• Currently participating in another prospective study including controlled clinical trials and observational studies
• Patient cannot or will not sign informed consent
• Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated
• Previous treatment with anti-tumor necrosis factor (anti-TNF) or other biologic agent

Trial design

483 participants in 2 patient groups

adalimumab

Description:

Responding to treatment with non-biologic DMARDs (disease-modifying antirheumatic drugs) and initiated on treatment with adalimumab as monotherapy or in combination with other medications

DMARD (disease-modifying antirheumatic drugs)

Description:

Initiated on non-biologic DMARD(disease-modifying antirheumatic drugs) or requiring switching to another non biologic DMARD (disease-modifying antirheumatic drugs) as monotherapy, or in combination with other medications