A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01834807

Enrollment

180

Registered

2013-04-18

Start date

2013-04-30

Completion date

2013-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice	approximately 1 year
Type of biological agents used in monotherapy in routine clinical practice	approximately 1 year

Secondary

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

Countries

Belgium

Outcome results