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

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VIBEX MTX
Sponsored by
Antares Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Altoona Center for Clinical Research

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

VIBEX MTX

Arm Description

VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
June 4, 2012
Last Updated
March 31, 2014
Sponsor
Antares Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01618955
Brief Title
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antares Pharma Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VIBEX MTX
Arm Type
Active Comparator
Arm Description
VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status
Intervention Type
Device
Intervention Name(s)
VIBEX MTX
Other Intervention Name(s)
prefilled autoinjector device
Intervention Description
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools
Description
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
Time Frame
24 hours
Title
Safety of Vibex MTX Device
Description
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
Time Frame
24 hours
Title
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)
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Kivitz, MD;CPI
Organizational Affiliation
Altoona Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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