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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: |
NCT02636907 |
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Date of registration:
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18/12/2015 |
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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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Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
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Scientific title:
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Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe |
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Date of first enrolment:
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January 6, 2016 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02636907 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Poland
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Ukraine
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which
is not adequately controlled by non-biologics DMARDs.
- No contraindications to anti-Tumor necrosis factor (TNF) agents.
- Either biologics naive or biologics-experienced but with no experience of
self-administration medication using autoinjector or pen.
- Patients must be able and willing to self-inject BI 695501. Further inclusion criteria
apply.
Exclusion criteria:
- Experience with self-administration of medication using an autoinjector or pen.
- American College of Rheumatology functional Class IV or wheelchair/ bed bound.
- Primary or secondary immunodeficiency.
- History of tuberculosis (TB). Further exclusion criteria apply.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Intervention(s)
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Drug: BI 695501 Autoinjector
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Drug: BI 695501 Prefilled syringe
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Primary Outcome(s)
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Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections
[Time Frame: Up to Day 50.]
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Secondary Outcome(s)
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Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
[Time Frame: Up to 17 weeks.]
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Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
[Time Frame: Up to 17 weeks.]
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Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
[Time Frame: Up to Day 50.]
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
[Time Frame: up to Week 60]
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
[Time Frame: up to Week 60]
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Secondary ID(s)
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1297.11
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2015-003030-27
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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