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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02682823 |
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Date of registration:
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11/02/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
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Scientific title:
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Tocilizumab Real-Life Human Factors Validation Study |
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Date of first enrolment:
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March 21, 2016 |
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Target sample size:
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91 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02682823 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Device: AI-1000 G2
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Drug: Tocilizumab
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Primary Outcome(s)
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Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
[Time Frame: Day 14]
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Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
[Time Frame: Day 28]
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Secondary Outcome(s)
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Swollen Joint Count (SJC) Among Participants With RA
[Time Frame: Baseline (Day 0)]
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Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
[Time Frame: 0 and 15 minutes after injection on Days 0, 14, 28]
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Percentage of Participants by Response to Device Satisfaction Questionnaire
[Time Frame: Days 0, 14, 28]
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Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
[Time Frame: Days 14, 28]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
[Time Frame: Days 0, 14, 28]
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Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
[Time Frame: 0 and 15 minutes after injection on Days 0, 14, 28]
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Tender Joint Count (TJC) Among Participants With RA
[Time Frame: Baseline (Day 0)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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