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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
      • Bruxelles, Belgium, 1070
      • Edegem, Belgium, 2650
      • Genk, Belgium, 3600
      • Gent, Belgium, 9000
      • Haine-Saint-Paul, Belgium, 7100
      • Kortrijk, Belgium, 8500
      • Liège, Belgium, 4000
      • Merksem, Belgium, 2170
      • Mons, Belgium, 7000
      • Seraing, Belgium, 4100
      • Turnhout, Belgium, 2300
      • Verviers, Belgium, 4800
      • Westmalle, Belgium, 2390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rheumatoid arthritis who are currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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