ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01791205

ML28552

Details and patient eligibility

About

This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a biologic drug in monotherapy as compared to therapy in combination with Disease-modifying anti-rheumatic drugs (DMARDs) will be evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be followed for up to18 months.

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Part 1:

• Adult patients, >/= 18 years of age
• Diagnosis of rheumatoid arthritis according to American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria
• Patients who received at least one cycle of biologic therapy, either in monotherapy or in combination, in the 12 months preceding the opening of the first site

Part 2:

• Patients on monotherapy with RoActemra/Actemra already enrolled in Part 1 of the study

Exclusion criteria

• Patients simultaneously participating in other studies with RoActemra/Actemra at the time of signing informed consent

Trial design

304 participants in 2 patient groups

Monotherapy

Description:

Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry will be observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy will be observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.

Combination Therapy

Description:

Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry will be observed for Phase I.