Clinical trial NCT02897817: Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis
Official title: Treatment Adherence in Patients With Rheumatoid Arthritis Previously Treated With Oral or Injectable Methotrexate and Requiring a New Treatment With Injectable Methotrexate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Methotrexate
Treatment adherence
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA patients currently treated with oral methotrexate (MTX) and requiring a switch to injectable MTX or currently treated with an injectable MTX and eligible for a change to a different MTX injection device will be asked to participate from RA treatment change (inclusion visit) up to 6 months after inclusion.

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.


Eligibility criteria: 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®).

Primary outcomes:
measure: Rate of patients whose adherence to methotrexate (MTX) remained strong or improved between inclusion (V0) and follow-up (V1) at 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of patient adherence between the 2 cohorts.
timeFrame: 6 months after inclusion.
measure: Reasons for non-adherence given by patients after 6 months.
timeFrame: 6 months after inclusion.
measure: Global and functional patient satisfaction with treatment after 6 months as assessed by the Likert scale for global satisfaction.
timeFrame: 6 months after inclusion.
measure: Global and functional patient satisfaction with treatment after 6 months as assessed by the Disease Activity Score 28 (DAS28) for disease severity.
timeFrame: 6 months after inclusion.
measure: Global and functional patient satisfaction with treatment after 6 months as assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) for functional disability.
timeFrame: 6 months after inclusion.
measure: 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.
timeFrame: 6 months after inclusion.
measure: 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.
timeFrame: 6 months after inclusion.
measure: 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.
timeFrame: 6 months after inclusion.
measure: Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on age.
timeFrame: 6 months after inclusion.
measure: Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on comorbidities.
timeFrame: 6 months after inclusion.
measure: 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.
timeFrame: 6 months after inclusion.
measure: 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.
timeFrame: 6 months after inclusion.
measure: 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).
timeFrame: 6 months after inclusion.
measure: 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).
timeFrame: 6 months after inclusion.
measure: 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).
timeFrame: 6 months after inclusion.
measure: 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.
timeFrame: 6 months after inclusion.
measure: 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).
timeFrame: 6 months after inclusion.
measure: Doctor satisfaction with the treatment after 6 months.
timeFrame: 6 months after inclusion.
measure: 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 .
timeFrame: 6 months after inclusion.
Other outcomes:
Locations:
city: Paris
country: France
facility: Nordic Pharma
Study officials:
affiliation: CHU Hôpital Roger Salengro, LILLE
name: René-Marc FLIPO, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctor's Office, MARSEILLE
name: Eric SENBEL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ANDAR
name: Sonia TROPE, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: NORDIC PHARMA
name: Hélène HERMAN-DEMARS, MD
role: STUDY_DIRECTOR
References: