Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Antares Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate (MTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01737944

MTX-10-001

Details and patient eligibility

About

Pharmacokinetics (PK) study

Full 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).

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 4 patient groups

10mg Methotrexate (MTX) Group

Experimental group

Description:

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

Treatment:

Drug: Methotrexate (MTX)

15mg Methotrexate (MTX) Group

Experimental group

Description:

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

Treatment:

Drug: Methotrexate (MTX)

20mg Methotrexate (MTX) Group

Experimental group

Description:

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

Treatment:

Drug: Methotrexate (MTX)

25mg Methotrexate (MTX) Group

Experimental group

Description:

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

Treatment:

Drug: Methotrexate (MTX)