Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis (APRim)

March 28, 2018 updated by: Nordic Pharma SAS

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75007
        • Nordic Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 6 months
Patient adherence is measured via the Morisky score at V0 and V1, using patient-reported outcome (PRO).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months after inclusion.
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.
6 months after inclusion.
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).
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.
Time Frame: 6 months after inclusion.
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.
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 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.
Time Frame: 6 months after inclusion.
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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).
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).
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).
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).
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).
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).
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.
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).
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).
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).
6 months after inclusion.
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.
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 .
Time Frame: 6 months after inclusion.
Treatment adherence is measured via the Morisky score at V0 and V1.
6 months after inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nordic Pharma SAS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APRim

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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