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

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ClinicalTrials.gov Identifier: NCT01418989
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra [ Time Frame: 21 days ]
  2. Peak plasma concentration of RoActemra/Actemra [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Safety (Incidence of adverse events) [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418989


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01418989     History of Changes
Other Study ID Numbers: NP25539
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016