Trial Outcomes & Findings for 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 (NCT NCT02636907)

Last Updated: 2018-07-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

Up to Day 50.

Results posted on

2018-07-10

Participant Flow

An Open-label, Interventional clinical trial followed by an extension phase of BI 695501 in patients with Rheumatoid Arthritis. EoT: End of treatment (EoT)

All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	BI 695501 Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Autoinjector Assessment Period STARTED	77
Autoinjector Assessment Period COMPLETED	73
Autoinjector Assessment Period NOT COMPLETED	4
Extension Phase STARTED	72
Extension Phase COMPLETED	62
Extension Phase NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 695501 Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Autoinjector Assessment Period Adverse Event	2
Autoinjector Assessment Period Withdrawal by Subject	2
Extension Phase Adverse Event	2
Extension Phase Withdrawal by Subject	4
Extension Phase Physician Decision	1
Extension Phase Lost to Follow-up	2
Extension Phase Lack of Efficacy	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 695501 n=77 Participants Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Age, Continuous	54.4 Years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 50.

Population: Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.

Outcome measures

Outcome measures
Measure	BI 695501 n=77 Participants Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
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	99.1 Percentage of injections Interval 96.72 to 99.75

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	BI 695501 n=77 Participants Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events Unsuccessful	0.9 Percentage of injections
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events Successful	99.1 Percentage of injections

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 695501 n=77 Participants Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions	6.5 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 695501 n=77 Participants Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment	11.7 Percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	BI 695501 n=77 Participants Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions	23.4 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 695501 n=77 Participants Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections.
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment	36.4 Percentage of participants

Adverse Events

BI 695501

Serious events: 9 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BI 695501 n=77 participants at risk Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections
Blood and lymphatic system disorders Anaemia	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Immune system disorders Drug hypersensitivity	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Psychiatric disorders Depression	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibroma	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Infections and infestations Device related infection	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Infections and infestations Wound infection	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Psychiatric disorders Drug use disorder	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Nervous system disorders Lumbar radiculopathy	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Vascular disorders Deep vein thrombosis	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Hepatobiliary disorders Autoimmune hepatitis	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Musculoskeletal and connective tissue disorders Spondylolisthesis	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
General disorders Chest pain	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
General disorders Complication associated with device	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
General disorders Non-cardiac chest pain	1.3% 1/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.

Other adverse events

Other adverse events
Measure	BI 695501 n=77 participants at risk Patients were administered BI 695501 solution for injection (40 milligram (mg)/0.8 milliliter (mL)) by subcutaneous injection every 2 weeks using an autoinjector (7-week Autoinjector Assessment Period) or Prefilled syringe (PFS) (optional 42-week Extension Phase). Patients were treated with up to 26 injections
Infections and infestations Sinusitis	7.8% 6/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Nervous system disorders Headache	10.4% 8/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Infections and infestations Upper respiratory tract infection	11.7% 9/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Infections and infestations Bronchitis	6.5% 5/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Infections and infestations Viral upper respiratory tract infection	6.5% 5/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Skin and subcutaneous tissue disorders Alopecia	5.2% 4/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	6.5% 5/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
Musculoskeletal and connective tissue disorders Back pain	5.2% 4/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
General disorders Injection site bruising	14.3% 11/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.
General disorders Injection site erythema	6.5% 5/77 • From first drug infusion until 10 weeks after last drug infusion, up to 376 days.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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