Rheumatic DiseasesNCT02926560
Study Medication Adherence and Its Determinants in Chronic Disease Through the Example of Methotrexate in Chronic Inflammatory Rheumatism
An observational study of Rheumatic Diseases, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The aim of this study is 1) To describe the level and determinants of methotrexate adherence in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in the department of rheumatology in the Nîmes University Hospital Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 30 May 2018
- Phase
- Observational
- 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
Study population: patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) treated by methotrexate in the department of rheumatology in the Nîmes University Hospital
Who may be able to join
- treated by methotrexate
- patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis)
Who cannot join
- methotrexate for other diseases
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is
- To describe the level and determinants of methotrexate adherence in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in the department of rheumatology in the Nîmes University Hospital
- Conditions
- Rheumatic Diseases
- Keywords
- Chronic inflammatory rheumatism
- Medical subject headings
- Rheumatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Measure= Morisky scale
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Gaujoux-Viala, MD,PhD, Principal investigator, CHU Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926560
- Sponsor's protocol ID
- Local/2015/CGV-02
- Status last verified
- Jan 2019
- First submitted
- 16 Sep 2016
- Last updated
- 14 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Medication Adherence and Its Determinants in Chronic Disease Through the Example of Methotrexate in Chronic Inflammatory Rheumatism
- ClinicalTrials.gov ID
- NCT02926560
- Acronym / sponsor ID
- Local/2015/CGV-02
- Conditions
- Rheumatic Diseases
- Keywords
- Chronic inflammatory rheumatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 6 Oct 2016 (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 aim of this study is
- To describe the level and determinants of methotrexate adherence in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in the department of rheumatology in the Nîmes University Hospital
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) treated by methotrexate in the department of rheumatology in the Nîmes University Hospital
Key inclusion criteria (2 listed)
- treated by methotrexate
- patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis)
Key exclusion criteria (1 listed)
- methotrexate for other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication Adherence Measure= Morisky scale
Time frame: day 0
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 14 Jan 2019.
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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.
Cécile Gaujoux-Viala, MD,PhD principal investigator
CHU Nîmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by Centre Hospitalier Universitaire de Nīmes 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 2 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 14 Jan 2019. 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?
Medication Adherence Measure= Morisky scale (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2019.