Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient

Medac

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: Methotrexate (Metoject® prefilled pen)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01871961

MC-MTX.15/HF

Details and patient eligibility

About

To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).

Enrollment: 105 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
• Male or female patient who is 16 years of age or older

Exclusion criteria

• Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
• Has any history of hypersensitivity to the investigational medicinal product
• Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA)
• Is unable to comprehend written labeling and training materials

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Methotrexate

Experimental group

Treatment:

Drug: Methotrexate (Metoject® prefilled pen)