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
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Drug: BI 695501 AutoinjectorDrug: BI 695501 Prefilled syringe
- Registration Number
- NCT02636907
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is an open-label, phase II study of BI 695501 to assess handling experience of patients with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients with additional exposure to BI 695501 and to enhance the safety database for this compound.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BI 695501 BI 695501 Prefilled syringe - BI 695501 BI 695501 Autoinjector -
- Primary Outcome Measures
Name Time Method 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 Up to Day 50. The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis.
Percentage of injections calculated relative to the total number of first injections.
- Secondary Outcome Measures
Name Time Method Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events Up to Day 50. The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c).
Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful).Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment Up to 17 weeks. A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication. Data is reported for the autoinjector assessment period. TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions up to Week 60 The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase. In Extension phase, patients were given diaries to record events between each site visit during extension phase. Patients were instructed to accurately record the following on the diary cards: the dates \& times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions. Patients were instructed to contact the site if they experienced any AEs between designated site visits. In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set
Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions Up to 17 weeks. Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
Percentage of subjects calculated relative to the total number of subjects in the analysis set.Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment up to Week 60 The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase. In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive. The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included). Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
Trial Locations
- Locations (19)
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Wojewodzki Szpital Zespolony w Elblagu
🇵🇱Elblag, Poland
Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
🇵🇱Gdynia, Poland
Rheumatology Clinic Of Houston, P.A.
🇺🇸Houston, Texas, United States
Inland Rheumatology Clinical Trials, Inc.
🇺🇸Upland, California, United States
Lovelace Scientific Resources, Incorporated
🇺🇸Venice, Florida, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Klein and Associates, M.D., P.A.
🇺🇸Cumberland, Maryland, United States
Albuquerque Center For Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Arthritis & Osteoporosis Associates LLP
🇺🇸Lubbock, Texas, United States
Heartland Research Associates, LLC
🇺🇸Nassau Bay, Texas, United States
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
🇵🇱Bialystok, Poland
Medical Centre Pratia Katowice I
🇵🇱Katowice, Poland
Specialist Center ALL-MED, Krakow
🇵🇱Krakow, Poland
Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
🇵🇱Torun, Poland
Medical Centre Pratia Warszawa
🇵🇱Warszawa, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
🇵🇱Wroclaw, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
🇵🇱Bydgoszcz, Poland
Medical Centre Pratia Krakow
🇵🇱Krakow, Poland