An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis

NCT ID: NCT01741688

Last Updated: 2017-08-01

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

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-26

Study Completion Date

2014-03-06

Brief Summary

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This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed 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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Tocilizumab

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab

Intervention Type BIOLOGICAL

Tocilizumab was administered according to the local label.

Interventions

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Tocilizumab

Tocilizumab was administered according to the local label.

Intervention Type BIOLOGICAL

Other Intervention Names

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Actemra

Eligibility Criteria

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Inclusion Criteria

* Adults, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
* Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit

Exclusion Criteria

* Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit
* Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
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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ABK Reuma SRL- Medicentro BioCiencias

Lima, , Peru

Site Status

Hospital de la Mujer

Lima, , Peru

Site Status

Clinica San Borja; Servicio De Reumatologia

Lima, , Peru

Site Status

Clinica El Golf

San Isidro, , Peru

Site Status

Countries

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Peru

Other Identifiers

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ML28206

Identifier Type: -

Identifier Source: org_study_id

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