Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

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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)

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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