Retrospective Study on the Use of Biologicals in Monotherapy in Rheumatoid Arthritis

Hoffmann-La Roche0 sites180 target enrollmentApril 2013

ConditionsRheumatoid Arthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 180
Primary Endpoint: Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

August 2013

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Diagnosis of rheumatoid arthritis
•Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)

Exclusion Criteria

•Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis
•Patients that have started their current monotherapy before 01/01/2009

Outcomes

Primary Outcomes

Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice

Time Frame: approximately 1 year

Type of biological agents used in monotherapy in routine clinical practice

Time Frame: approximately 1 year

Secondary Outcomes

Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores(approximately 1 year)
Safety of biologics used in monotherapy: Incidence of adverse events(approximately 1 year)
Quality of life: HAQ-DI score(approximately 1 year)