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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01618955
First received: June 4, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis (RA)
Device: VIBEX MTX
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Antares Pharma Inc.:

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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    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

    1. Ease of use Questionnaire was completed by patients immediately after self-injection
    2. Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator

  • Safety of Vibex MTX Device [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 101
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VIBEX MTX
VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status
Device: VIBEX MTX
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
Other Name: prefilled autoinjector device

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618955

Locations
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
Principal Investigator: Alan J Kivitz, MD;CPI Altoona Center for Clinical Research
  More Information

No publications provided

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT01618955     History of Changes
Other Study ID Numbers: MTX-11-002
Study First Received: June 4, 2012
Results First Received: February 14, 2014
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014