Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

NCT ID: NCT02809833

Last Updated: 2016-10-24

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

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-03-31

Brief Summary

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This prospective, multicenter, non-interventional study will enroll participants from routine clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study is systematic collection of data on use of tocilizumab in daily routine with special emphasis on treatment decision by the prescriber, compliance with Summary of Product Characteristics (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The maximum observation period will be 12 months per participant.

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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Tocilizumab for RA in Routine Practice

Participants from routine clinical practice in Germany who are receiving tocilizumab for RA according to SmPC are eligible.

Tocilizumab

Intervention Type DRUG

Tocilizumab must be selected by the treating physician in advance of the study and will be not provided by the Sponsor. The dose/regimen are at the discretion of the prescriber. However, tocilizumab in the SmPC is specified as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.

Interventions

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Tocilizumab

Tocilizumab must be selected by the treating physician in advance of the study and will be not provided by the Sponsor. The dose/regimen are at the discretion of the prescriber. However, tocilizumab in the SmPC is specified as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.

Intervention Type DRUG

Other Intervention Names

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Actemra/RoActemra

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe RA
* Tocilizumab indicated in accordance with SmPC and chosen by the treating physician in advance of the study

Exclusion Criteria

* None specified
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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Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML22734

Identifier Type: -

Identifier Source: org_study_id

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