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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01418989
First received: August 16, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label, multi-center study will compare the bioavailability of RoActemr

a/Actemra (tocilizumab) administration by auto-injector versus pre-filled syring e in healthy volunteers. Healthy volunteers will receive a single dose of RoActe mra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.


Condition Intervention Phase
Healthy Volunteer
Drug: tocilizumab [RoActemra/Actemra] auto-injector
Drug: tocilizumab [RoActemra/Actemra] Syringe
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Peak plasma concentration of RoActemra/Actemra [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (Incidence of adverse events) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: July 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra] auto-injector
Single dose administration with auto-injector
Experimental: 2 Drug: tocilizumab [RoActemra/Actemra] Syringe
Single dose administration with pre-filled syringe

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418989

Locations
France
Montpellier, France, 34094
Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01418989     History of Changes
Other Study ID Numbers: NP25539
Study First Received: August 16, 2011
Last Updated: July 7, 2014
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on July 24, 2014