Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab; Device: AI-1000 G2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02682823

WA29917

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 5 patient groups

Caregivers

Experimental group

Description:

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.

Treatment:

Device: AI-1000 G2

Drug: Tocilizumab

Healthcare Professionals

Experimental group

Description:

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.

Treatment:

Device: AI-1000 G2

Drug: Tocilizumab

RA Group 1 (Self-Administration)

Experimental group

Description:

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.

Treatment:

Device: AI-1000 G2

Drug: Tocilizumab

RA Group 2 (Administration by CG)

Other group

Description:

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.

Treatment:

Device: AI-1000 G2

Drug: Tocilizumab

RA Group 3 (Administration by HCP)

Other group

Description:

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.

Treatment:

Device: AI-1000 G2

Drug: Tocilizumab