Arthritis, RheumatoidPhase 2NCT02636907
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
A Phase 2 study testing BI 695501 Autoinjector and BI 695501 Prefilled syringe in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- BI 695501 Autoinjector and BI 695501 Prefilled syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 6 Jan 2016to 29 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Poland10 sites
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, 15-099
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 85-168
Wojewodzki Szpital Zespolony w Elblagu
Elblag, 82-300
Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
Gdynia, 81-338
Medical Centre Pratia Katowice I
Katowice, 40-954
Medical Centre Pratia Krakow
Krakow, 30-002
Specialist Center ALL-MED, Krakow
Krakow, 31-023
Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
Torun, 87-100
Medical Centre Pratia Warszawa
Warsaw, 01-868
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, 51-128
United States9 sites
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, 87102
Klein and Associates, M.D., P.A.
Cumberland, Maryland, 21502
Metroplex Clinical Research Center
Dallas, Texas, 75231
Rheumatology Clinic Of Houston, P.A.
Houston, Texas, 77065
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, 79424
Heartland Research Associates, LLC
Nassau Bay, Texas, 77058
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786
Lovelace Scientific Resources, Incorporated
Venice, Florida, 34292
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
About this study
Official title: 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- BI 695501 Autoinjector, BI 695501 Prefilled syringe
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 695501 AutoinjectorDrug
BI 695501 Prefilled syringeDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 695501 | Experimental | Not described Receives: Drug: BI 695501 Autoinjector; Drug: BI 695501 Prefilled syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 50.
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start6 Jan 2016
- Primary completion21 Jun 2016
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636907
- Sponsor's protocol ID
- 1297.11
- Other IDs
- 2015-003030-27, 2015
- Status last verified
- Jun 2018
- First submitted
- 18 Dec 2015
- Last updated
- 10 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 29764238
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02636907
- Acronym / sponsor ID
- 1297.11
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 21 Jun 2016 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 695501 | Experimental | Drug: BI 695501 Autoinjector, Drug: BI 695501 Prefilled syringe |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 695501 Autoinjector | Drug | BI 695501 |
| BI 695501 Prefilled syringe | Drug | BI 695501 |
Primary outcome
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.
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.
5 secondary outcomes
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
Time frame: Up to Day 50.
Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
Time frame: Up to 17 weeks.
Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
Time frame: Up to 17 weeks.
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
Time frame: up to Week 60
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29764238Cohen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 695501 Autoinjector and BI 695501 Prefilled syringe in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.