Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete-AS)

AbbVie

Status: Completed

Conditions: Ankylosing Spondylitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01387802

P12-672

Details and patient eligibility

About

The current study will assess the real - life effectiveness of adalimumab in the management of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of extra-articular manifestations.

Enrollment: 722 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 Ankylosing Spondylitis as per the judgment of the treating physician
• Inadequate response or non tolerant to current NSAID (Nonsteroidal Anti-Inflammatory Drug) or DMARD (Disease-Modifying Anti Rheumatic Drug) based treatment for AS

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-TNF (Tumor Necrosis Factor) or other biologic agent
• Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of AS

Trial design

722 participants in 2 patient groups

Non-Biologic arm

Description:

Patients that have not responded to the current treatment with an NSAID (Nonsteroidal Anti-Inflammatory Drug) and/or non - biologic DMARD (Disease-Modifying Anti Rheumatic Drug) for peripheral joint involvement and switch to or addition of another NSAID /DMARDS

Biologic arm

Description:

Patients that have not responded to the current treatment with non biologic DMARDS (Disease-Modifying Anti Rheumatic Drug) /NSAID (Nonsteroidal Anti-Inflammatory Drug) and switch to or addition of adalimumab