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Completed

NCT Number: NCT02897817

Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Health Behavior Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nordic Pharma

Paris, 75007, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®).

Treatment and study plan

Primary outcomes

  1. 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

  1. Comparison of patient adherence between the 2 cohorts.

    Time frame: 6 months after inclusion.

    Analysis of improved or equivalent patient adherence as assessed by the Morisky score at V0 and V1 between the 2 cohorts.

  2. Reasons for non-adherence given by patients after 6 months.

    Time frame: 6 months after inclusion.

    Assessed in the overall patient population and between the 2 cohorts.

  3. Global and functional patient satisfaction with treatment after 6 months as assessed by the Likert scale for global satisfaction.

    Time frame: 6 months after inclusion.

    Global patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the Likert scale (1 to 5 rating).

  4. Global and functional patient satisfaction with treatment after 6 months as assessed by the Disease Activity Score 28 (DAS28) for disease severity.

    Time frame: 6 months after inclusion.

    Patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the DAS28.

  5. Global and functional patient satisfaction with treatment after 6 months as assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) for functional disability.

    Time frame: 6 months after inclusion.

    Patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the HAQ-DI.

  6. 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.

    Time frame: 6 months after inclusion.

    Patient satisfaction will be assessed in the overall patient population and between the 2 cohorts using the EMIR.

  7. 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.

    Time frame: 6 months after inclusion.

    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).

  8. 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.

    Time frame: 6 months after inclusion.

    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).

  9. Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on age.

    Time frame: 6 months after inclusion.

    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).

  10. Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on comorbidities.

    Time frame: 6 months after inclusion.

    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).

  11. 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.

    Time frame: 6 months after inclusion.

    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).

  12. 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.

    Time frame: 6 months after inclusion.

    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).

  13. 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).

    Time frame: 6 months after inclusion.

    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).

  14. 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).

    Time frame: 6 months after inclusion.

    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).

  15. 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).

    Time frame: 6 months after inclusion.

    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).

  16. 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.

    Time frame: 6 months after inclusion.

    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).

  17. 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).

    Time frame: 6 months after inclusion.

    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).

  18. Doctor satisfaction with the treatment after 6 months.

    Time frame: 6 months after inclusion.

    Assessed in the overall patient population and between the 2 cohorts.

  19. 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 .

    Time frame: 6 months after inclusion.

    Treatment adherence is measured via the Morisky score at V0 and V1.

Sponsors and collaborators

Lead sponsor

Nordic Pharma SAS

Industry

Registry information

Official study title

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

Acronym: APRim

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2016
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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