Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe

A National, Randomized, Open-label Study Comparing Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated With Methotrexate Administered by Auto-injector Versus Administration by Conventional Subcutaneous Injection.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02553018

Acronym

Self-i

Enrollment

278

Registered

2015-09-17

Start date

2015-09-30

Completion date

2017-08-31

Last updated

2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Brief summary

The primary objective of the study is to compare, in patients treated with methotrexate injection for rheumatoid arthritis, the compliance and the health assessment questionnaire evolution for the administration by auto-injector versus administration by conventional subcutaneous injection, after 6 months of treatment.

Interventions

DRUGMethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patient (18 years or over) of either sex. * With established rheumatoid arthritis diagnosis * Treated for rheumatoid arthritis by methotrexate (oral or by injection) since at least 3 months regardless of the prior or combined disease modifying treatment, except biotherapies and justifying injection of methotrexate. For the patient treated by oral methotrexate, the switch decided by the rheumatologist is made for either safety, compliance or efficacy issues. * Agreeing to participate in the study and having dated and signed the informed consent form.

Exclusion criteria

* Patients fulfilling one or more of the following

Design outcomes

Primary

Measure	Time frame	Description
Co-primary criteria: observance and health assessment questionnaire	6 months	the health assessment questionnaire is completed by the patient at inclusion visit and at the 6 months visit. Compliance with methotrexate treatment will be assessed by the investigator at each visit

Secondary

Measure	Time frame	Description
quality of life	6 months	Patient's quality of life will be assessed using a validated questionnaire. completed by the patient at inclusion and 6 months visits. Change from baseline in questionnaire score will be described.
acceptability	up to 1 year	The product acceptability will be evaluated by the patient using a specific questionnaire based on several questions related to the patient' opinion, satisfaction and willingness to adopt the product.
preference	6 months	Preference will be assessed only for patients receiving auto-injector and pre-filled syringe of methotrexate
Economic	6 months	Information on the consumed resources for methotrexate administration will be assessed at 6 months. This information will be further incorporated in a budget impact for the French Sickness Fund

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026