A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-24

Study Completion Date

2017-12-07

Brief Summary

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This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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RA participants treated with a TNF inhibitor or TCZ

Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed.

TNF inhibitor/TCZ

Intervention Type DRUG

Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed.

Interventions

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TNF inhibitor/TCZ

Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed.

Intervention Type DRUG

Other Intervention Names

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COTTON

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age.
* With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria.
* Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors).
* The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment.
* Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.

Exclusion Criteria

* Have had more than one TNF-inhibitor prior to the enrolment visit.
* Have had biological treatment other than TNF-inhibitors.
* Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No