NCT02897817

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

August 4, 2016

Last Update Submit

March 28, 2018

Conditions

Rheumatoid Arthritis

Keywords

MethotrexateTreatment adherence

Outcome Measures

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.

    Patient adherence is measured via the Morisky score at V0 and V1, using patient-reported outcome (PRO).

    6 months

Secondary Outcomes (19)

  • Comparison of patient adherence between the 2 cohorts.

    6 months after inclusion.

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

    6 months after inclusion.

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

    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.

    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.

    6 months after inclusion.

  • +14 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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®).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordic Pharma

Paris, 75007, France

Location

MeSH Terms

Conditions

Arthritis, RheumatoidTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Hélène HERMAN-DEMARS, MD

    NORDIC PHARMA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

September 13, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

FR(1)