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A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis

NCT ID: NCT01649804

Last Updated: 2016-11-04

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

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RoActemra/Actemra single arm

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

8 mg/kg intravenously every 4 weeks for 104 weeks

Interventions

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tocilizumab [RoActemra/Actemra]

8 mg/kg intravenously every 4 weeks for 104 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult participants, \>/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
* No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
* Receiving treatment on an outpatient basis

Exclusion Criteria

* Females who are pregnant
* Participants who have prematurely withdrawn from the core study WA19926 for any reason
* Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
* Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
* Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
* Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
* Abnormal laboratory values
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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Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Eger, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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2011-006125-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28146

Identifier Type: -

Identifier Source: org_study_id