Arthritis, RheumatoidPhase 3Self-iNCT02553018
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
A Phase 3 study testing Methotrexate in people with Arthritis, Rheumatoid, run by Nordic Pharma SAS at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2015to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 :
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Auto-injector of methotrexate, METOJECT
| Study group | Role | What they receive |
|---|---|---|
| Auto-injector of methotrexate | Experimental | 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 Receives: Drug: Methotrexate |
| Pre-filled syringe of methotrexate | Active comparator | 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 Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
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.
Measured: up to 1 year
preference
Preference will be assessed only for patients receiving auto-injector and pre-filled syringe of methotrexate
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553018
- Sponsor's protocol ID
- MD-112014
- Acronym
- Self-i
- Status last verified
- Oct 2017
- First submitted
- 16 Sep 2015
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30547379
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02553018
- Acronym / sponsor ID
- Self-i / MD-112014
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Nordic Pharma SASIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto-injector of methotrexate | Experimental | Drug: MethotrexateThe 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 comparator | Drug: MethotrexatePre-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- Patients fulfilling one or more of the following exclusion criteria will not be included in the study:
- hypersensitivity to methotrexate or to any of the excipients,
- severe hepatic impairment,
- alcohol abuse,
- severe renal impairment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: Auto-injector of methotrexate, METOJECT | Drug | Auto-injector of methotrexate, Pre-filled syringe of methotrexate |
Primary outcome
Co-primary criteria: observance and health assessment questionnaire
Time frame: 6 months
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
4 secondary outcomes
quality of life
Time frame: 6 months
acceptability
Time frame: up to 1 year
preference
Time frame: 6 months
Economic
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Derived from this study: PubMed 30547379Saraux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate in people with Arthritis, Rheumatoid, run by Nordic Pharma SAS at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary criteria: observance and health assessment questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02553018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.