Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618955
• Other study ID #: MTX-11-002
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2012
• Last updated: March 31, 2014
• Start date: May 2012
• Est. completion date: July 2012

Study information

• Verified date: March 2014
• Source: Antares Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.

Description:

Primary objective:

• To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions

Secondary objectives:

• To evaluate the reliability and robustness of the VIBEX MTX device

• To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device

• To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients >18 years of age, diagnosed with Rheumatoid Arthritis

Exclusion Criteria:

• Pregnant females

• Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Device:
• VIBEX MTX
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device

Locations

Country	Name	City	State
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Antares Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection	A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.; The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following: SC self-injection was administered by the patient; SC self-injection was intentional; self-injection was administered in an appropriate location on the abdomen; patient removed cap marked "1"; patient removed cap marked "2"; patient held device at injection site for 3 seconds; patient confirmed that the window was obstructed	24 hours	Yes
Secondary	Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools	A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device; Ease of use Questionnaire was completed by patients immediately after self-injection; Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator	24 hours	Yes
Secondary	Safety of Vibex MTX Device	A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device; Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following: Erythema - 0 = None; Erythema - 1 = Very slight, barely perceptible; Erythema - 2 = Obvious, but well defined; Erythema - 3 = Moderate to severe; Erythema - 4 = Severe	24 hours	Yes
Secondary	Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)	A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.; Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection.	24 hours	Yes