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
NCT ID: NCT02553018
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
278 participants
INTERVENTIONAL
2015-09-30
2017-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Auto-injector of methotrexate
The 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
Methotrexate
Pre-filled syringe of methotrexate
Pre-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
Methotrexate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methotrexate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nordic Pharma SAS
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SARAUX
Brest, , France
HUDRY
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD-112014
Identifier Type: -
Identifier Source: org_study_id