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Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

NCT ID: NCT01737944

Last Updated: 2014-02-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

Brief Summary

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Pharmacokinetics (PK) study

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Detailed Description

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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).

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10mg Methotrexate (MTX) Group

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

Group Type EXPERIMENTAL

Methotrexate (MTX)

Intervention Type DRUG

Vibex MTX Device

15mg Methotrexate (MTX) Group

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

Group Type EXPERIMENTAL

Methotrexate (MTX)

Intervention Type DRUG

Vibex MTX Device

20mg Methotrexate (MTX) Group

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

Group Type EXPERIMENTAL

Methotrexate (MTX)

Intervention Type DRUG

Vibex MTX Device

25mg Methotrexate (MTX) Group

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

Group Type EXPERIMENTAL

Methotrexate (MTX)

Intervention Type DRUG

Vibex MTX Device

Interventions

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Methotrexate (MTX)

Vibex MTX Device

Intervention Type DRUG

Other Intervention Names

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Device with MTX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antares Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan J Kivitz, MD;CPI

Role: PRINCIPAL_INVESTIGATOR

Altoona Center for Clinical Research

Locations

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Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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MTX-10-001

Identifier Type: -

Identifier Source: org_study_id

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