Trials Sponsors Conditions Drugs Pricing

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)

Sponsors & Collaborators

Nordic Pharma SAS
Industrylead

Study Sites (1)

Nordic Pharma

Paris, 75007, France

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

Enrollment

471 participants (actual enrollment reported by the registry).

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 2016

Actual (reported)

Treatment Adherence to Injectable Methotrexate in Rheumatoid Arthritis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (2)

Oral to Injectable

Injectable to Injectable

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (2)

Oral to Injectable

Injectable to Injectable

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations