Defining Remission With Etanercept in AS in Real Life Clinical Practice (REACH AS)

Pfizer

Status: Completed

Conditions: Ankylosing Spondylitis

Treatments: Drug: etanercept

Study type: Observational

Funder types: Industry

Identifiers

NCT02202850

B1801379 (Other Identifier)

REACH-AS (Other Identifier)

Details and patient eligibility

About

Determine which remission criterion at Month 6 predicts remission at Month 12 the best.

Full description

The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 6 independent variables as ASAS partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status.

This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups.

In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop-out rate of 30% over 1 year period.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with AS who start treatment with Etanercept according to prevailing reimbursement criteria and dosing in line with SmPC.

   1. First cohort: Etanercept is the first biological product prescribed
   2. Second cohort: Etanercept is the second biological product prescribed

2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.

3. 18 years of age or older at time of consent

4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

1. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.

Trial design

84 participants in 2 patient groups

Etanercept First

Description:

Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium

Treatment:

Drug: etanercept

Drug: etanercept

Etanercept second

Description:

Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium

Treatment:

Drug: etanercept

Drug: etanercept