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
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.
1 other identifier
interventional
278
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 16, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 6, 2017
October 1, 2017
1.9 years
September 16, 2015
October 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
quality of life
6 months
acceptability
up to 1 year
preference
6 months
Economic
6 months
Study Arms (2)
Auto-injector of methotrexate
EXPERIMENTALThe Auto-injector is a disposable, fixed, single dose, auto-injector to be used for Methotrexate (25mg/ml) therapy. Dosage form: solution for injection Dosage: 0.3ml contains 7.5mg of Methotrexate, 0.4ml contains the 10.0mg of Methotrexate, 0.6ml contains 15.0 mg of Methotrexate, 0.8ml contains 20.0 mg of Methotrexate, 1.0ml contains 25.0 mg of Methotrexate. Frequency: one injection per week Duration: until the end of the study
Pre-filled syringe of methotrexate
ACTIVE COMPARATORPre-filled syringes contains a volume of 1 ml with attached injection needle. Dosage form: solution for injection. Dosage: 0.15 ml contains 7.5 mg of methotrexate, 20 ml contains 10 mg of methotrexate, 0.30 ml contains 15 mg of methotrexate, 0.40 ml contains 20 mg of methotrexate, 0.50 ml contains 25 mg of methotrexate disodium. Frequency: one injection per week Duration: until the end of the study
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
SARAUX
Brest, France
HUDRY
Paris, France
Related Publications (1)
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.
PMID: 30547379DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2015
First Posted
September 17, 2015
Study Start
September 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
October 6, 2017
Record last verified: 2017-10