Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-21

Study Completion Date

2016-07-29

Brief Summary

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This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Caregivers

CGs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

Group Type EXPERIMENTAL

AI-1000 G2

Intervention Type DEVICE

Tocilizumab will be administered using the AI-1000 G2.

Tocilizumab

Intervention Type DRUG

Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.

Healthcare Professionals

HCPs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

Group Type EXPERIMENTAL

AI-1000 G2

Intervention Type DEVICE

Tocilizumab will be administered using the AI-1000 G2.

Tocilizumab

Intervention Type DRUG

Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.

RA Group 1 (Self-Administration)

Participants with RA will perform self-injection of SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

Group Type EXPERIMENTAL

AI-1000 G2

Intervention Type DEVICE

Tocilizumab will be administered using the AI-1000 G2.

Tocilizumab

Intervention Type DRUG

Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.

RA Group 2 (Administration by CG)

CGs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

Group Type OTHER

AI-1000 G2

Intervention Type DEVICE

Tocilizumab will be administered using the AI-1000 G2.

Tocilizumab

Intervention Type DRUG

Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.

RA Group 3 (Administration by HCP)

HCPs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visit 1 (Day 0) will be performed by the study nurse. Visits 2 and 3 (Days 14 and 28) will be conducted by the HCP for use/performance evaluation.

Group Type OTHER

AI-1000 G2

Intervention Type DEVICE

Tocilizumab will be administered using the AI-1000 G2.

Tocilizumab

Intervention Type DRUG

Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.

Interventions

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AI-1000 G2

Tocilizumab will be administered using the AI-1000 G2.

Intervention Type DEVICE

Tocilizumab

Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.

Intervention Type DRUG

Other Intervention Names

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Actemra/RoActemra, RO4877533

Eligibility Criteria

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Inclusion Criteria

* Participants with RA for greater than or equal to (\>/=6) months receiving 162 mg tocilizumab PFS-NSD for \>/=8 weeks and who are suitable for continued treatment at their currently prescribed dose
* CGs and professionally qualified HCPs who are able and willing to administer the injection

Exclusion Criteria

* RA: Functional status Class IV
* RA: Neuropathies or other conditions that might interfere with pain evaluation
* RA: Pregnant or breastfeeding
* RA: Low neutrophil or platelet count at last laboratory assessment
* RA: Elevated liver enzymes at last laboratory assessment
* Current participation in another interventional clinical trial
* Criteria that might give the participant/CG/HCP an advantage in injection tasks such as employment in the pharmaceutical industry, etc.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No