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Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

10 mg Methotrexate (MTX)

15 mg MTX

20 mg MTX

25 mg MTX

Arm Description

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Outcomes

Primary Outcome Measures

Dose-Normalized AUC[0-Inf] for MTX
Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment
Dose-Normalized AUC[0-24] for MTX
Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment
Dose-Normalized Cmax for MTX
Dose-normalized maximum observed concentration (Cmax) for each treatment

Secondary Outcome Measures

Full Information

First Posted
June 4, 2012
Last Updated
May 8, 2014
Sponsor
Antares Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01618968
Brief Title
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
Official Title
Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 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
Relative Bioavailability Comparison study
Detailed Description
A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg Methotrexate (MTX)
Arm Type
Experimental
Arm Description
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
Arm Title
15 mg MTX
Arm Type
Experimental
Arm Description
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
Arm Title
20 mg MTX
Arm Type
Experimental
Arm Description
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
Arm Title
25 mg MTX
Arm Type
Experimental
Arm Description
MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
Intervention Type
Drug
Intervention Name(s)
MTX
Other Intervention Name(s)
Commercially available 2.5 mg MTX oral tablets, VIBEX MTX
Intervention Description
Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group) Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)
Primary Outcome Measure Information:
Title
Dose-Normalized AUC[0-Inf] for MTX
Description
Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment
Time Frame
24 Hour period
Title
Dose-Normalized AUC[0-24] for MTX
Description
Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment
Time Frame
24 Hour period
Title
Dose-Normalized Cmax for MTX
Description
Dose-normalized maximum observed concentration (Cmax) for each treatment
Time Frame
24 Hour period

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

Citations:
PubMed Identifier
24728329
Citation
Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014 Aug;73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.
Results Reference
derived

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Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

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