Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

  • Rheumatoid Arthritis
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT02682823 WA29917

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 4 Phase
      NCT02682823 , WA29917 Trial Identifier
      AI-1000 G2, Tocilizumab Treatments
      Rheumatoid Arthritis Condition
      Official Title

      Tocilizumab Real-Life Human Factors Validation Study

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      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.

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