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

Arthritis, Rheumatoid Clinical Trial

— Self-i  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553018
• Other study ID #: MD-112014
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2015
• Last updated: October 5, 2017
• Start date: September 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Nordic Pharma SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria will not be included in the study:

• Inability of patient to use an auto-injector.

• Treated with biotherapies.

• Pregnant or breast-feeding patients

• Male and female patients with reproductive potential who are not willing to use effective method of contraception (oral contraceptives, intrauterine device, condoms) during study and at least 1 month after the end of the study.

• Patients with :

• hypersensitivity to methotrexate or to any of the excipients,

• severe hepatic impairment,

• alcohol abuse,

• severe renal impairment,

• pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia,

• Immunodeficiency,

• serious, acute or chronic infections such as tuberculosis and HIV,

• stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease,

• concurrent vaccination with live vaccines.

• Association with probenecid, trimethoprim, phenylbutazone.

• Any other known medical or surgical history, disorder or disease judged by the investigator to be incompatible with the study (such as acute or chronic severe organic disease: hepatic, endocrine, neoplasia, haematological, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc…),

• Inability of patient to understand the study procedures and thus inability to give informed consent.

• Participation in another clinical study, at the same time as the present study, or during the month following the end of the previous study

• Ward of court.

• Patient not covered by the Social Security.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Methotrexate

Locations

Country	Name	City	State
France	SARAUX	Brest
France	HUDRY	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Pharma SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-primary criteria: observance and health assessment questionnaire	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	6 months
Secondary	quality of life	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.	6 months
Secondary	acceptability	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.	up to 1 year
Secondary	preference	Preference will be assessed only for patients receiving auto-injector and pre-filled syringe of methotrexate	6 months
Secondary	Economic	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	6 months