NCT01418989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

August 16, 2011

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra

    21 days

  • Peak plasma concentration of RoActemra/Actemra

    21 days

Secondary Outcomes (1)

  • Safety (Incidence of adverse events)

    28 days

Study Arms (2)

1

EXPERIMENTAL
Drug: tocilizumab [RoActemra/Actemra] auto-injector

2

EXPERIMENTAL
Drug: tocilizumab [RoActemra/Actemra] Syringe

Interventions

tocilizumab [RoActemra/Actemra] SyringeDRUG

Single dose administration with pre-filled syringe

2
tocilizumab [RoActemra/Actemra] auto-injectorDRUG

Single dose administration with auto-injector

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Montpellier, 34094, France

Location

Unknown Facility

Rennes, 35042, France

Location

MeSH Terms

Interventions

tocilizumabSyringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 17, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(2)