Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA) (SIMPACT)

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02402686

ML29719

Details and patient eligibility

About

The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria
• Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
• Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate

Exclusion criteria

• Treatment with tocilizumab more than 8 weeks prior to enrollment
• Failure to meet local tocilizumab label indication criteria
• Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
• Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
• History of any other autoimmune or joint inflammatory disease

Trial design

353 participants in 1 patient group

Tocilizumab for RA in Routine Clinical Practice

Description:

Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation.

Treatment:

Drug: Tocilizumab