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Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

NCT ID: NCT03112213

Last Updated: 2018-12-13

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

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-12

Study Completion Date

2018-07-17

Brief Summary

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This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous \[SC\] or intravenous \[IV\]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).

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

PROSPECTIVE

Study Groups

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Participants With RA

Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use.

Tocilizumab

Intervention Type DRUG

Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.

NSAIDs

Intervention Type DRUG

Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.

Interventions

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Tocilizumab

Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.

Intervention Type DRUG

NSAIDs

Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.

Intervention Type DRUG

Other Intervention Names

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RoACTEMRA®

Eligibility Criteria

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Inclusion Criteria

* Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV)
* Current users of NSAIDs due to RA as assessed by the physician

Exclusion Criteria

* Contraindications to treatment with tocilizumab as per SPC
* Prior therapy with tocilizumab
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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Rheumazentrum Kupka

Altenburg, , Germany

Site Status

Praxis für Rheumatologie.

Amberg, , Germany

Site Status

Kerckhoff-Klinik; Rheumatologie&klin.Immunologie

Bad Nauheim, , Germany

Site Status

Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

Berlin, , Germany

Site Status

Praxis für Innere Medizin - Rheumatologie

Berlin, , Germany

Site Status

Rheuma Praxis Berlin Sven Remstedt

Berlin, , Germany

Site Status

Praxis Dr. Silke Zinke

Berlin, , Germany

Site Status

Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken

Burghausen, , Germany

Site Status

Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

Dresden, , Germany

Site Status

Praxis Dr. med. Semmler; Facharzt für Innere Medizin

Güstrow, , Germany

Site Status

Dres.Karin Babinsky und Anke Liebhaber

Halle, , Germany

Site Status

Rheumatologische Schwerpunktpraxis

Hanover, , Germany

Site Status

Rheumapraxis PD Dr.med. Bernhard Heilig

Heidelberg, , Germany

Site Status

Rheumatologische Facharztpraxis Maren Sieburg

Magdeburg, , Germany

Site Status

Praxis für Innere Medizin und Rheumatologie

Mansfeld, , Germany

Site Status

Praxis Prof. Dr.med. Herbert Kellner

München, , Germany

Site Status

Praxiszentrum St. Bonifatius

München, , Germany

Site Status

Rheumatologische Praxis

Neubrandenburg, , Germany

Site Status

Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg

Neuss, , Germany

Site Status

Praxis Dr.med. Christoph Volberg

Neuss, , Germany

Site Status

Praxis Dr. Albert

Offenburg, , Germany

Site Status

Praxis für Rheumatologie Dr. med. Hauke E. Heintz

Poppenbüttel, , Germany

Site Status

Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen

Püttlingen, , Germany

Site Status

Rheumazentrum Ratingen - Studienambulanz

Ratingen, , Germany

Site Status

Praxis Dr.med. Werner A. Biewer

Saarbrücken, , Germany

Site Status

Rheumatologische Schwerpunktpraxis am Feuersee

Stuttgart, , Germany

Site Status

Praxis für Rheumatologie

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML30088

Identifier Type: -

Identifier Source: org_study_id