Conditions: Rheumatoid Arthritis
Keywords: methotrexate injection, subcutaneous, autoinjector
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 38
Healthy volunteers: no

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).

Arms:
arm 1: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 2: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 3: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 4: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection

Interventions: intervention 1: Methotrexate (MTX)
Intervention descriptions: intervention 1: Vibex MTX Device

Protocol document: