Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— APRim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897817
• Other study ID #: APRim
• Status: Completed
• First received: August 4, 2016
• Last updated: March 28, 2018
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Nordic Pharma SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
France	Nordic Pharma	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Pharma SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Doctor satisfaction with the treatment after 6 months.	Assessed in the overall patient population and between the 2 cohorts.	6 months after inclusion.
Secondary	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.