A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

NCT ID: NCT01664104

Last Updated: 2017-07-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-12-31

Brief Summary

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This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.

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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RA Participants

Participants with moderate or severe RA who are under tocilizumab treatment in routine clinical practice (in accordance with the local label) will be observed for 6 months from the start of treatment.

Tocilizumab

Intervention Type DRUG

Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.

Interventions

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Tocilizumab

Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria
* Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment

Exclusion Criteria

* Participants who have started tocilizumab treatment more than 3 months prior to site opening
* Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use
* Participants who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
* Participants with a history of autoimmune disease or joint inflammatory disease other than RA
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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Coppito, Abruzzo, Italy

Site Status

Barletta, Apulia, Italy

Site Status

Casarano (LE), Apulia, Italy

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Foggia, Apulia, Italy

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Reggio Calabria, Calabria, Italy

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Benevento, Campania, Italy

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Telese Terme, Campania, Italy

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Bologna, Emilia-Romagna, Italy

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Rome, Lazio, Italy

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Bergamo, Lombardy, Italy

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Castel Goffredo, Lombardy, Italy

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Gavardo, Lombardy, Italy

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Milan, Lombardy, Italy

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Monza, Lombardy, Italy

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Pavia, Lombardy, Italy

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Novara, Piedmont, Italy

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Catania, Sicily, Italy

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Catania, Sicily, Italy

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Palermo, Sicily, Italy

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Florence, Tuscany, Italy

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Pisa, Tuscany, Italy

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Cona (Ferrara), Veneto, Italy

Site Status

Verona, Veneto, Italy

Site Status

Verona, Veneto, Italy

Site Status

Countries

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Italy

Other Identifiers

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ML28336

Identifier Type: -

Identifier Source: org_study_id

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