The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients

AbbVie

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Device: Adalimumab delivered in Physiolis autoinjector; Device: Adalimumab delivered in Physiolis syringe; Device: Adalimumab delivered in current autoinjector; Device: Adalimumab delivered in current syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01163617

M12-088

Details and patient eligibility

About

This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis pre-filled syringe and autoinjector used to administer adalimumab.

Full description

This was a Phase 2, open-label study consisting of 2 study phases with a total of 3 study visits, each visit occurring 2 weeks apart from each other. Phase A (User Experience) was a randomized, 2-period, cross-over phase in which single subcutaneous (SC) dose injections were administered using either the Physiolis autoinjector and current autoinjector or the Physiolis syringe and current syringe in a 1:1 ratio. Phase B (Injection Time) was a randomized, single-visit, parallel-arm phase, with injection into a test tube, and one SC injection given to participants using the Physiolis autoinjector or current autoinjector administered at 2 different temperature ranges (2° to 8°C [storage temperature] and 20° to 27°C [room temperature]). If a participant only completed Visit 1 and Visit 2, then the participant was to be replaced for Visit 3. If the participant only completed Visit 1, the participant was to be replaced for all study visits.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject was judged to be in good health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and a 12-lead electrocardiogram performed during Screening.
• Subject had a negative purified protein derivative (PPD) test (or equivalent) and chest x-ray (posterior-anterior and lateral view) at Screening.
• Subject has a diagnosis of moderate to severe rheumatoid arthritis and is treated with adalimumab in accordance with the FDA-approved Humira prescribing information.
• Subject must have self-administered adalimumab subcutaneous (SC) 40 mg injections every other week (eow) without interruption for at least 3 months prior to Screening.
• For the Phase A portion of the study, the subject must be able and willing to self administer SC injections in the thigh or abdomen (administration by another person was not permissible).

Exclusion criteria

• Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Visit 1, with the exception of adalimumab.
• Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Visit 1 or oral anti-infectives within 14 days prior to Visit 1.
• Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
• Known hypersensitivity to adalimumab or its excipients.
• Regular use of any SC medications, with the exception of adalimumab.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

85 participants in 8 patient groups

Current/Physiolis Syringe

Experimental group

Description:

Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)

Treatment:

Device: Adalimumab delivered in current syringe

Device: Adalimumab delivered in Physiolis syringe

Physiolis/Current Syringe

Experimental group

Description:

Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)

Treatment:

Device: Adalimumab delivered in current syringe

Device: Adalimumab delivered in Physiolis syringe

Current/Physiolis Autoinjector

Experimental group

Description:

Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)

Treatment:

Device: Adalimumab delivered in current autoinjector

Device: Adalimumab delivered in Physiolis autoinjector

Physiolis/Current Autoinjector

Experimental group

Description:

Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)

Treatment:

Device: Adalimumab delivered in current autoinjector

Device: Adalimumab delivered in Physiolis autoinjector

Physiolis Autoinjector at 2° to 8°C

Experimental group

Description:

Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)

Treatment:

Device: Adalimumab delivered in Physiolis autoinjector

Current Autoinjector 2° to 8°C

Experimental group

Description:

Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)

Treatment:

Device: Adalimumab delivered in current autoinjector

Physiolis Autoinjector 20° to 27°C

Experimental group

Description:

Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)

Treatment:

Device: Adalimumab delivered in Physiolis autoinjector

Current Autoinjector 20° to 27°C

Experimental group

Description:

Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)

Treatment:

Device: Adalimumab delivered in current autoinjector