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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02553018
• Date of registration: 16/09/2015
• Prospective Registration: No
• Primary sponsor: Nordic Pharma SAS
• Public title: 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 Self-i
• Scientific 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.
• Date of first enrolment: September 2015
• Target sample size: 278
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02553018
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Methotrexate

Primary Outcome(s)

Co-primary criteria: observance and health assessment questionnaire [Time Frame: 6 months]

Secondary Outcome(s)

acceptability [Time Frame: up to 1 year]

Economic [Time Frame: 6 months]

quality of life [Time Frame: 6 months]

preference [Time Frame: 6 months]

Secondary ID(s)

MD-112014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors