Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice (REACH RA)

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: etanercept

Study type: Observational

Funder types: Industry

Identifiers

NCT02202837

REACH-RA (Other Identifier)

B1801378 (Other Identifier)

Details and patient eligibility

About

Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept

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 5 independent variables as CDAI, SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and clinical studies.

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: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the 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. Eighteen (18) years of age or older at time of consent.

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

157 participants in 2 patient groups

Etanercept First

Description:

Adult patients with RA who receive etanercept as first biologic, according to prevailing Belgian reimbursement criteria

Treatment:

Drug: etanercept

Drug: etanercept

Etanercept second

Description:

Adult patients who receive etanercept as second biologic, according to prevailing Belgian reimbursement criteria

Treatment:

Drug: etanercept

Drug: etanercept