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

NCT ID: NCT01834807

Last Updated: 2016-11-02

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

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Aalst, , Belgium

Site Status

Brussels, , Belgium

Site Status

Edegem, , Belgium

Site Status

Genk, , Belgium

Site Status

Ghent, , Belgium

Site Status

Haine-Saint-Paul, , Belgium

Site Status

Kortrijk, , Belgium

Site Status

Liège, , Belgium

Site Status

Merksem, , Belgium

Site Status

Mons, , Belgium

Site Status

Seraing, , Belgium

Site Status

Turnhout, , Belgium

Site Status

Verviers, , Belgium

Site Status

Westmalle, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML28540

Identifier Type: -

Identifier Source: org_study_id