An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01664117

ROC-BIO-2011-01 (Other Identifier)

ML28356

Details and patient eligibility

About

This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/=18 years of age
• Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs
• Patients treated with biologic DMARDs alone for at least 6 months

Exclusion criteria

• Patients not willing or unable to give written informed consent for participation in this study
• Patients who are participating in any clinical trial at the time of this study

Trial design

210 participants in 1 patient group

bDMARD Monotherapy

Description:

Patients with moderate to severe rheumatoid arthritis (RA) will be treated with bDMARD (biologic disease-modifying antirheumatic drug) monotherapy under routine clinical practice conditions at rheumatology clinics