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An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

NCT ID: NCT01388309

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

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-03-31

Brief Summary

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This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 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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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis
* Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion Criteria

* Pregnant or lactating women
* Active infection
* Positive for hepatitis B, hepatitis C or HIV infection
* Concomitant anti-TNF drugs
* Contraindications to treatment with 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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Banská Bystrica, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Košice, , Slovakia

Site Status

Piešťany, , Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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ML25524

Identifier Type: -

Identifier Source: org_study_id