NCT02897817CompletedNot Applicable
Treatment Adherence in Patients With Rheumatoid Arthritis Previously Treated With Oral or Injectable Methotrexate and Requiring a New Treatment With Injectable Methotrexate
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nordic Pharma SAS
- Enrollment
- 471
- Locations
- 1
- Primary Endpoint
- Rate of patients whose adherence to methotrexate (MTX) remained strong or improved between inclusion (V0) and follow-up (V1) at 6 months.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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®).
Outcomes
Primary Outcomes
Rate of patients whose adherence to methotrexate (MTX) remained strong or improved between inclusion (V0) and follow-up (V1) at 6 months.
Time Frame: 6 months
Patient adherence is measured via the Morisky score at V0 and V1, using patient-reported outcome (PRO).
Secondary Outcomes
- Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on socio-professional standing.(6 months after inclusion.)
- Global and functional patient satisfaction with treatment after 6 months as assessed by the Likert scale for global satisfaction.(6 months after inclusion.)
- Global and functional patient satisfaction with treatment after 6 months as assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) for functional disability.(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on age.(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on comorbidities.(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, as evaluated by the Morisky score at V0 and V1, based on global patient satisfaction (assessed by Likert scale results).(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, evaluated by the change in the Morisky scores at V0 and V1, based on whether the injection was self-administered or administered by a third party.(6 months after inclusion.)
- Comparison of patient adherence between the 2 cohorts.(6 months after inclusion.)
- Global and functional patient satisfaction with treatment after 6 months as assessed by the Disease Activity Score 28 (DAS28) for disease severity.(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on family situation.(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on the co-administration of other injectable treatments.(6 months after inclusion.)
- Reasons for non-adherence given by patients after 6 months.(6 months after inclusion.)
- Global and functional patient satisfaction with treatment after 6 months as assessed by the Echelle de Mesure de l'Impact de la polyarthrite Rhumatoïde (EMIR) for quality of life.(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on the reasons for the switch to new MTX injection device.(6 months after inclusion.)
- Treatment adherence, evaluated by the Morisky score at 6 months, as assessed by the HCP compared to the treatment adherence as reported by the patient .(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on rheumatoid arthritis severity (assessed by DAS28).(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, evaluated by the change in the Morisky scores at V0 and V1, based on patient functional handicap (assessed by the HAQ-DI).(6 months after inclusion.)
- Analysis of improvement or maintenance of patient adherence, evaluated by the change in the Morisky scores at V0 and V1, based on tolerability and level of patient trust with HCP (assessed by Likert scale results).(6 months after inclusion.)
- Doctor satisfaction with the treatment after 6 months.(6 months after inclusion.)
Investigators
Study Sites (1)
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