Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis

NCT ID: NCT02897817

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral to Injectable

Patients treated with oral MTX and requiring a switch to injectable MTX

No interventions assigned to this group

Injectable to Injectable

Patients treated with injectable MTX and eligible for a change in MTX injection device.

No interventions assigned to this group

Eligibility Criteria

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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®).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordic Pharma SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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René-Marc FLIPO, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

CHU Hôpital Roger Salengro, LILLE

Eric SENBEL, MD

Role: PRINCIPAL_INVESTIGATOR

Doctor's Office, MARSEILLE

Sonia TROPE, Nurse

Role: PRINCIPAL_INVESTIGATOR

ANDAR

Hélène HERMAN-DEMARS, MD

Role: STUDY_DIRECTOR

NORDIC PHARMA

Locations

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Nordic Pharma

Paris, , France

Site Status

Countries

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France

Other Identifiers

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APRim

Identifier Type: -

Identifier Source: org_study_id

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