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An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids

NCT ID: NCT01564901

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

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

Brief Summary

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This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.

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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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults patients, over 18 years of age
* Patients with moderate to severe rheumatoid arthritis (RA)
* Patients on a stable dose of prednisone or equivalent (\>/=7.5 mg/day) for at least 4 weeks before study inclusion

Exclusion Criteria

* Patients previously treated with RoActemra/Actemra
* Any contraindication to RoActemra/Actemra
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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Vitoria-Gasteiz, Alava, Spain

Site Status

Alicante, Alicante, Spain

Site Status

Elche, Alicante, Spain

Site Status

Palma de Mallorca, Balearic Islands, Spain

Site Status

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Huesca, Huesca, Spain

Site Status

León, Leon, Spain

Site Status

Ponferrada, Leon, Spain

Site Status

Salamanca, Salamanca, Spain

Site Status

Alzira, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Bilbao, Vizcaya, Spain

Site Status

Countries

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Spain

Other Identifiers

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ML27904

Identifier Type: -

Identifier Source: org_study_id