Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)

AbbVie

Status: Completed

Conditions: Ankylosing Spondylitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01079182

P10-147

Details and patient eligibility

About

The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.

Full description

This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.

Enrollment: 4,681 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
2. Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
3. No contraindications for anti-tumor necrosis factors (TNF) therapy.

Exclusion criteria

1. Participants who do not meet the above listed inclusion criteria.

Trial design

4,681 participants in 1 patient group

Ankylosing spondylitis

Description:

Participants with ankylosing spondylitis