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

NCT01618955 | Completed Phase 2 Results

• 1 other identifier: MTX-11-002
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• 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: 1. SC self-injection was administered by the patient 2. SC self-injection was intentional 3. self-injection was administered in an appropriate location on the abdomen 4. patient removed cap marked "1" 5. patient removed cap marked "2" 6. patient held device at injection site for 3 seconds 7. patient confirmed that the window was obstructed

  24 hours

Secondary Outcomes (3)

• Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools

  24 hours

• Safety of Vibex MTX Device

  24 hours

• 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)

  24 hours

Study Arms (1)

VIBEX MTX

ACTIVE COMPARATOR

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

Device: VIBEX MTX

Interventions

VIBEX MTX DEVICE

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

Also known as: prefilled autoinjector device

VIBEX MTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Antares Pharma Inc.: lead

Study Sites (1)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Jonathan Jaffe, MD; Vice President-Clinical Development
• Organization: Antares Pharma Inc.

jjaffe@antarespharma.com

609-359-3020

Study Officials

• Alan J Kivitz, MD;CPI

  Altoona Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 14, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 30, 2014
• Results First Posted: April 30, 2014

Record last verified: 2014-03

Locations

US (1)