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Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Methotrexate (MTX)

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring methotrexate injection, subcutaneous, autoinjector

Eligibility Criteria

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

Inclusion Criteria:

Male or female >18 years of age with diagnosed Rheumatoid Arthritis(RA).

Exclusion Criteria:

Chronic or acute renal disease
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

Arm Label

10mg Methotrexate (MTX) Group

15mg Methotrexate (MTX) Group

20mg Methotrexate (MTX) Group

25mg Methotrexate (MTX) Group

Arm Description

Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Outcomes

Primary Outcome Measures

Bioequivalence Based Upon 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

Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX

Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment

Bioequivalence Based Upon Dose-Normalized Cmax for MTX

Dose-normalized maximum observed concentration for each treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT01737944

First Posted

November 27, 2012

Last Updated

January 8, 2014

Sponsor

Antares Pharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01737944

Brief Title

Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Official Title

Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Antares Pharma Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pharmacokinetics (PK) study

Detailed Description

To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

methotrexate injection, subcutaneous, autoinjector

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10mg Methotrexate (MTX) Group

Arm Type

Experimental

Arm Description

Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Arm Title

15mg Methotrexate (MTX) Group

Arm Type

Experimental

Arm Description

Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Arm Title

20mg Methotrexate (MTX) Group

Arm Type

Experimental

Arm Description

Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Arm Title

25mg Methotrexate (MTX) Group

Arm Type

Experimental

Arm Description

Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Intervention Type

Drug

Intervention Name(s)

Methotrexate (MTX)

Other Intervention Name(s)

Device with MTX

Intervention Description

Vibex MTX Device

Primary Outcome Measure Information:

Title

Bioequivalence Based Upon 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

Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX

Description

Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment

Time Frame

24 Hour period

Title

Bioequivalence Based Upon Dose-Normalized Cmax for MTX

Description

Dose-normalized maximum observed concentration for each treatment

Time Frame

24 Hour period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female >18 years of age with diagnosed Rheumatoid Arthritis(RA). Exclusion Criteria: Chronic or acute renal disease 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

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Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

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