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A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis

NCT ID: NCT01462162

Last Updated: 2016-10-31

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

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-11-30

Brief Summary

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This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 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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Rheumatoid Arthritis Participants

Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center will be followed-up for 6 months.

Tocilizumab

Intervention Type DRUG

Interventions

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Tocilizumab

Intervention Type DRUG

Other Intervention Names

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RoActemra Actemra

Eligibility Criteria

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Inclusion Criteria

* Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).

Exclusion Criteria

* Participants previously or currently treated with RoActemra/Actemra in clinical trials
* Absolute neutrophil count less than or equal to (\</=) 2x10\^9 per liter (/L)
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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Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Mollet del Vallès, Barcelona, Spain

Site Status

Sabadell, Barcelona, Spain

Site Status

Sant Joan Despí, Barcelona, Spain

Site Status

Girona, Girona, Spain

Site Status

A Coruña, La Coruña, Spain

Site Status

Lugo, Lugo, Spain

Site Status

Cartagena, Murcia, Spain

Site Status

El Palmar, Murcia, Spain

Site Status

Lorca, Murcia, Spain

Site Status

Ourense, Orense, Spain

Site Status

Vigo, Pontevedra, Spain

Site Status

Tarragona, Tarragona, Spain

Site Status

Tarragona, Tarragona, Spain

Site Status

Countries

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Spain

Other Identifiers

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ML27833

Identifier Type: -

Identifier Source: org_study_id