A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

NCT ID: NCT00810277

Last Updated: 2017-08-03

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-05-26

Brief Summary

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This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.

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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1

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

8mg/kg iv every 4 weeks for 24 weeks

Interventions

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tocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* moderate to severe rheumatoid arthritis;
* inadequate response to current non-biologic DMARDs

Exclusion Criteria

* rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
* previous treatment with other biologics.
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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Kanta-Hämeen Keskussairaala ; Reumatologia

Hämeenlinna, , Finland

Site Status

Kiljavan Lääketutkimus Oy

Hyvinkää, , Finland

Site Status

Kanta-Hämeen keskussairaala; Riihimäen aluesairaala Reumapoliklinikka

Riihimäki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2008-004126-16

Identifier Type: -

Identifier Source: secondary_id

ML22012

Identifier Type: -

Identifier Source: org_study_id

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