Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis (APRim)

Nordic Pharma

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02897817

APRim

Details and patient eligibility

About

The aim of this study is to evaluate, at 6 months, the rate of patients whose adherence to injectable MTX remained strong or improved according to patient-reported outcome.

Enrollment: 471 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥ 18 years old)

• Patients with a diagnosis of RA as confirmed by the ACR/EULAR (2010) Classification Criteria for Rheumatoid Arthritis

• Patients:

  • currently treated with oral MTX and requiring a switch to an injectable MTX* or
  • currently treated with an injectable MTX* and eligible for a change of MTX injection device*

• Patients informed about and accepting the computer processing of their medical data and their right of accesss and correction.

Exclusion criteria

• Patients who refuse to participate in the study or are unable to fill out the patient diary.

*On the basis of the products marketed at the time of submission of the study to Oversight Authorities (Méthotrexate Biodim®, Metoject® and imeth®).

Trial design

471 participants in 2 patient groups

Oral to Injectable

Description:

Patients treated with oral MTX and requiring a switch to injectable MTX

Injectable to Injectable

Description:

Patients treated with injectable MTX and eligible for a change in MTX injection device.