MethotrexateMETHO-PRNCT03107299
Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
A study testing Communication methods to encourage adherence in people with Methotrexate and Polyarthritis; Rheumatoid, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methotrexate, Polyarthritis; Rheumatoid
- What is being tested?
- Communication methods to encourage adherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2016to 5 Apr 2019
- Phase
- Interventional
- 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 patients attending Day Hospital or consultation of rheumatology with rheumatoid polyarteritis and under treatment with MTX alone or in combination with another therapeutic, fixed dosage for at least 3 months.
- Consenting Patient
- Literate French-speaking patient,
- Patient with a mobile phone
- Patient affiliated to a social security scheme
Who cannot join
- Patient not managing his own treatment
Trial locations and contacts
1 site in 1 country.
About this study
Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.
The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.
For this purpose, 3 methods of communication have been put in place to encourage adherence: usual care by the rheumatologist, sms sending or pharmaceutical maintenance.
- Conditions
- Methotrexate, Polyarthritis; Rheumatoid
- Being tested
- Communication methods to encourage adherence
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication methods to encourage adherenceOther
Prospective randomized controlled study in intention to treat in open monocentric in 3 arms: all patients benefiting from the current management (medical consultation every 4 to 6 months in the department of rheumatology)
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Not described Receives: Other: Communication methods to encourage adherence |
| Send sms to patients | Other | Not described Receives: Other: Communication methods to encourage adherence |
| pharmaceutical maintenance following medical consultation | Other | Not described Receives: Other: Communication methods to encourage adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start5 Jul 2016
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
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 MethotrexateStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107299
- Sponsor's protocol ID
- PI2016_843_0006
- Acronym
- METHO-PR
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mary A, Boursier A, Desailly Henry I, Grados F, Sejourne A, Salomon S, Fardellone P, Brazier M, Goeb V. Mobile Phone Text Messages and Effect on Treatment Adherence in Patients Taking Methotrexate for Rheumatoid Arthritis: A Randomized Pilot Study. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1344-1352. doi: 10.1002/acr.23750.
PubMed 30192070
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03107299
- Acronym / sponsor ID
- METHO-PR / PI2016_843_0006
- Conditions
- Methotrexate, Polyarthritis; Rheumatoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.
The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.
For this purpose, 3 methods of communication have been put in place to encourage adherence: usual care by the rheumatologist, sms sending or pharmaceutical maintenance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Communication methods to encourage adherence |
| Send sms to patients | Other | Other: Communication methods to encourage adherence |
| pharmaceutical maintenance following medical consultation | Other | Other: Communication methods to encourage adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients attending Day Hospital or consultation of rheumatology with rheumatoid polyarteritis and under treatment with MTX alone or in combination with another therapeutic, fixed dosage for at least 3 months.
- Consenting Patient
- Literate French-speaking patient,
- Patient with a mobile phone
- Patient affiliated to a social security scheme
Key exclusion criteria (1 listed)
- Patient not managing his own treatment
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 |
|---|---|---|
| Communication methods to encourage adherenceProspective randomized controlled study in intention to treat in open monocentric in 3 arms: all patients benefiting from the current management (medical consultation every 4 to 6 months in the department of rheumatology) | Other | Control, Send sms to patients, pharmaceutical maintenance following medical consultation |
Primary outcome
CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis.
Time frame: 10 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 15 Jun 2026.
- Derived from this study: PubMed 30192070Mary A, Boursier A, Desailly Henry I, Grados F, Sejourne A, Salomon S, Fardellone P, Brazier M, Goeb V. Mobile Phone Text Messages and Effect on Treatment Adherence in Patients Taking Methotrexate for Rheumatoid Arthritis: A Randomized Pilot Study. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1344-1352. doi: 10.1002/acr.23750.
Related trials for Methotrexate
Active, not recruitingPhase 4
Comparison of Efficacy and Safety of Deucravacitinib Versus Methotrexate in the Treatment of Moderate-to-Severe Plaque Psoriasis .
Psoriasis
Active, not recruitingPhase 2
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
RecruitingPhase 2
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant
Acute Leukemia, Myelodysplastic Syndrome
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication methods to encourage adherence in people with Methotrexate and Polyarthritis; Rheumatoid, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 5 inclusion and 1 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis. (time frame: 10 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 NCT03107299, 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 15 Jun 2026.