Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis (APRim)

Treatment Adherence in Patients With Rheumatoid Arthritis Previously Treated With Oral or Injectable Methotrexate and Requiring a New Treatment With Injectable Methotrexate

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 471

Contacts and Locations

Study Locations

• France
  • Paris, France, 75007
    • Nordic Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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®).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Oral to Injectable; Patients treated with oral MTX and requiring a switch to injectable MTX
Injectable to Injectable; Patients treated with injectable MTX and eligible for a change in MTX injection device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients whose adherence to methotrexate (MTX) remained strong or improved between inclusion (V0) and follow-up (V1) at 6 months.	Patient adherence is measured via the Morisky score at V0 and V1, using patient-reported outcome (PRO).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of patient adherence between the 2 cohorts.	Analysis of improved or equivalent patient adherence as assessed by the Morisky score at V0 and V1 between the 2 cohorts.	6 months after inclusion.
Reasons for non-adherence given by patients after 6 months.	Assessed in the overall patient population and between the 2 cohorts.	6 months after inclusion.
Global and functional patient satisfaction with treatment after 6 months as assessed by the Likert scale for global satisfaction.	Global patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the Likert scale (1 to 5 rating).	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.	Patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the DAS28.	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.	Patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the HAQ-DI.	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.	Patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the EMIR.	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.	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing family situation. Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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 socio-professional standing.	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing socio-professional standing. Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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.	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing age. Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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.	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing comorbidities. Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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.	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing the co-administration of other injectable treatments (binary variable). Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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.	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing the reasons for the switch to new MTX injection device. Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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).	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing rheumatoid arthritis severity (assessed by DAS28). Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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).	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing functional handicap (assessed by the HAQ-DI). Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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).	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing global patient satisfaction (assessed by Likert scale results). Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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.	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing whether the injection was self-administered or administered by a third party. Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	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).	Identification of factors associated with the improvement or maintenance of adherence in the overall patient population and between the 2 cohorts by assessing tolerability and level of patient trust with HCP (assessed by Likert scale results). Adherence is evaluated by the change in the Morisky scores at V0 and V1, with a score of 0 considered as strong adherence and a score >0 considered as non-adherence. Patient adhesion is classified as remaining strong if the Morisky score at V0 and V1 remains at 0 and patient adhesion is classified as improved if the Morisky score at V0 is greater than 0 (non-adherent) while the score at V1 is 0 (strong adherence).	6 months after inclusion.
Doctor satisfaction with the treatment after 6 months.	Assessed in the overall patient population and between the 2 cohorts.	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 .	Treatment adherence is measured via the Morisky score at V0 and V1.	6 months after inclusion.

Collaborators and Investigators

• Sponsor: Nordic Pharma SAS
• Investigators: Principal Investigator: René-Marc FLIPO, MD, Prof, CHU Hôpital Roger Salengro, LILLE; Principal Investigator: Eric SENBEL, MD, Doctor's Office, MARSEILLE; Principal Investigator: Sonia TROPE, Nurse, ANDAR; Study Director: Hélène HERMAN-DEMARS, MD, Nordic Pharma

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Methotrexate; Treatment adherence
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: APRim