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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: BI 695501 Autoinjector; Drug: BI 695501 Prefilled syringe

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland, 15-099
    • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • Elblag, Poland, 82-300
    • Wojewódzki Szpital Zespolony w Elblągu
  • Gdynia, Poland, 81-338
    • Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
  • Katowice, Poland, 40-954
    • Medical Centre Pratia Katowice I
  • Krakow, Poland, 30-002
    • Medical Centre Pratia Krakow
  • Krakow, Poland, 31-023
    • Specialist Center ALL-MED, Krakow
  • Torun, Poland, 87-100
    • Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
  • Warszawa, Poland, 01-868
    • Medical Centre Pratia Warszawa
  • Wroclaw, Poland, 51-128
    • Wojewodzki Szpital Specjalistyczny We Wroclawiu
• United States
  • California
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials, Inc.
  • Florida
    • Venice, Florida, United States, 34292
      • Lovelace Scientific Resources, Incorporated
  • Maryland
    • Cumberland, Maryland, United States, 21502
      • Klein and Associates, M.D., P.A.
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center for Rheumatology
  • Texas
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Houston, Texas, United States, 77065
      • Rheumatology Clinic of Houston, P.A.
    • Lubbock, Texas, United States, 79424
      • Arthritis & Osteoporosis Associates LLP
    • Nassau Bay, Texas, United States, 77058
      • Heartland Research Associates, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 695501	Drug: BI 695501 Autoinjector; Drug: BI 695501 Prefilled syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to Day 50.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events	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).	Up to Day 50.
Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions	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.	Up to 17 weeks.
Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment	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.	Up to 17 weeks.
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions	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	up to Week 60
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment	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.	up to Week 60

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Cohen S, Klimiuk PA, Krahnke T, Assudani D. Successful administration of BI 695501, an adalimumab biosimilar, using an autoinjector (AI): results from a Phase II open-label clinical study (VOLTAIRE(R)-RL). Expert Opin Drug Deliv. 2018 Jun;15(6):545-548. doi: 10.1080/17425247.2018.1472572. Epub 2018 May 15.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2016
• Primary Completion (Actual): June 21, 2016
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 1297.11; 2015-003030-27 (EudraCT Number)