Clinical trial NCT02553018: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Co-primary criteria: observance and health assessment questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: quality of life
timeFrame: 6 months
measure: acceptability
timeFrame: up to 1 year
measure: preference
timeFrame: 6 months
measure: Economic
timeFrame: 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: SARAUX
city: Paris
country: France
facility: HUDRY
Study officials:
References:
citation: Saraux A, Hudry C, Zinovieva E, Herman-Demars H; Self-I Investigators group. Use of Auto-Injector for Methotrexate Subcutaneous Self-Injections: High Satisfaction Level and Good Compliance in SELF-I Study, a Randomized, Open-Label, Parallel Group Study. Rheumatol Ther. 2019 Mar;6(1):47-60. doi: 10.1007/s40744-018-0134-2. Epub 2018 Dec 13.