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A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers

NCT ID: NCT01418989

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

Clinical Phase

PHASE1

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-11-30

Brief Summary

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This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra] auto-injector

Intervention Type DRUG

Single dose administration with auto-injector

2

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra] Syringe

Intervention Type DRUG

Single dose administration with pre-filled syringe

Interventions

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tocilizumab [RoActemra/Actemra] Syringe

Single dose administration with pre-filled syringe

Intervention Type DRUG

tocilizumab [RoActemra/Actemra] auto-injector

Single dose administration with auto-injector

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, age 18 to 65 years inclusive
* Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection
* A body mass index (BMI) between 18 to 32 kg/m2 inclusive

Exclusion Criteria

* Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
* A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Montpellier, , France

Site Status

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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NP25539

Identifier Type: -

Identifier Source: org_study_id