Good EULAR Response In Patients With Early Rheumatoid Arthritis (EARLY RA)

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: methotrexate; Drug: etanercept

Study type: Observational

Funder types: Industry

Identifiers

NCT01558089

B1801138

Details and patient eligibility

About

This open-label, prospective, observational study will evaluate the clinical response to etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis, as prescribed by the rheumatologist in a normal clinical setting in Greece

Full description

All subjects enrolled should meet the usual prescribing criteria for Etanercept as per the local product information and should be entered into the study at the investigator's discretion

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. signed and dated informed consent document
2. 18 years of age and older at the time of consent
3. Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria
4. Patients who have been prescribed for first time to receive treatment with MTX + Etanercept prior to enrollment to this study, following routine clinical practice and according to the approved SmPC,
5. Patients with DAS28 ≥ 3.2
6. Duration of disease symptoms ≥ 6 weeks and ≤2 years
7. Failure to respond to prior DMARDs including MTX monotherapy according to routine clinical practice.

Exclusion criteria

1. Contraindications according to the SmPC
2. History of or present anti-TNFa or other biologic therapy for the treatment of RA
3. Known significant concurrent medical disease according to investigator's opinion and the current SmPC

Trial design

76 participants in 1 patient group

etanercept + methotrexate

Treatment:

Drug: etanercept

Drug: methotrexate