Rheumatoid ArthritisCannabisRICNCT04402554
Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- What is being tested?
- Cannabis questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 501 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2020to 19 Mar 2021
- 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, whether rheumatoid arthritis or spondyloarthritis, seen in consultation in the department of Rheumatology
Who may be able to join
- Rheumatoid Arthritis (ACR 2010 Criteria)
- Ankylosing Spondylitis (New york or ASAS criteria)
- Psoriatic Arthritis (CASPAR criteria)
Who cannot join
- Patient unable to complete questionnaires or unable to express informed consent
- Guardianship, trusteeship, deprivation of liberties, safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis.
The aim of this study is to assess the percentage of patients who use cannabis to better relieve their pain or anxiety in chronic inflammatory rheumatism.
Read the detailed description
Thanks to a better understanding of the pathophysiological mechanisms of inflammatory rheumatism, rheumatology has known for several decades a growth in its therapeutic arsenal (csDMARDs, bDMARDs, tDMARDs). rheumatism control has thus been optimized.
however, patients very often keep pain, anxiety, residual fatigue, poorly controlled by our conventional therapies. patients then turn to non-drug therapies, among which the use of cannabis.
endocannabinoids have an analgesic and anti-inflammatory action recognized in pre-clinical trials. however, investigators currently lack the data to authorize its use in clinical rheumatology.
the aim of this study is to determine the prevalence of cannabis users in patients with rheumatoid arthritis, ankylosing spondyloarthritis or psoriatic arthritis in our unit. as a second intention, investigators will refine the consumption characteristics. Investigators will also look for possible risk factors for consumption (sensitivity to pain, catastrophism, standard of living, anxiety, depression, rheumatic activity and quality of life).
- Being tested
- Cannabis questionnaire
- Keywords
- Cannabis, Cannabis/therapeutic use, Cannabis/therapy, Medical Marijuana, Chronic Pain, Rheumatic Diseases, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Marijuana Abuse, Chronic Pain, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis questionnaireBehavioural
The effectiveness and use of cannabis in the management of chronic pain has been well known for many years, but has so far been illegal and therefore largely unacknowledged. We hypothesize that the use of cannabis in this population of patients with chronic joint or spinal pain is not anecdotal and responds to a need to further improve the overall management of patients. The objective of our anonymous questionnaire is to estimate the prevalence of cannabis use in patients with chronic inflammatory rheumatism.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of cannabis use in patients with chronic inflammatory rheumatic conditions
Patients will answer the following question: Are you currently using cannabis - Yes or No
Measured: Day 0
Secondary outcomes (7)
Percentage of patients with problematic cannabis use
Questionnaire CAST score. It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7
Measured: Day 0
Assessing the association between cannabis use and disease activity of spondylitis ankylosing
Spondylitis ankylosing activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.
Measured: Day 0
Assessing the association between cannabis use and disease activity of rheumatoid arthritis / psoriatic arthritis
Rheumatoid arthritis / psoriatic arthritis was assessed by Disease Activity Score including 28 joints (DAS 28). DAS 28 includes the 28 swollen joint count (28 SJC) + the 28 tender joint count (28 TJC) + patient global assessments of disease activity on a VAS, + ESR or CRP. [DAS (VS) = 0,56 x √TJC + 0,28 x √SJC + 0,7 x ln(VS) + 0,014 x VAS ; DAS (CRP) = 0,56 x √TJC + 0,28 x √SJC + 0,36 x ln(CRP + 1) + 0,014 x VAS + 0,96 ]. The scores according to EULAR criteria are: ≤2.6 for remission, >2.6 and ≤3.2 for low disease activity, >3.2 and ≤5.1 for moderate disease activity and >5.1 for high disease activity.
Measured: Day 0
Assessing the association between cannabis use and functional disability
Functional disability was assessed by Health Assessment Questionnaire Disability Index (HAQ DI). HAQ-DI is an index that measures the impact of pathology on everyday activities such as dressing, eating, walking, etc.
The following note is allocated to each question: 0 = without any difficulty ; 1 = with some difficulty ; 2 = with great difficulty ; 3 = unable to do so
Measured: Day 0
Assessing the association between cannabis use and Anxiety/Depression
Anxiety and depression was assessed by Hospital Anxiety and Depression scale (HADs). 14 items scored from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing two scores to be obtained (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D): - 7 or less: absence of symptoms - 8 to 10: doubtful symptoms - 11 and more: certain symptoms.
Measured: Day 0
Assessing the association between cannabis use and pain catastrophism
Catastrophism was assessed by Pain catastrophisme scale (PCS). PCS is a thirteen-item scale to identify and quantify the extent of catastrophism in a painful patient. Three subgroups group together the criteria related to rumination (items 8,9,10,11), exaggeration (items 6,7,13) and vulnerability (items 1,2,3,4,5,12) . Patients are asked to rate their personal experience using a five-point rating from 0 to 4. The final score can therefore vary from 0 to 52. A PCS score of 30 or more represents a relevant clinical level of catastrophism.
Measured: Day 0
Assessing the association between cannabis use and social vulnerability
level of social vulnerability was assessed by Assessment of Precariousness and Health Inequalities in Health Examination Centers (EPICES) questionnaire.
.
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 posted27 May 2020
- Study start19 May 2020
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Mathieu, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402554
- Sponsor's protocol ID
- RNI 2020 MATHIEU
- Other IDs
- 2020-A00473-36
- Acronym
- CannabisRIC
- Status last verified
- Jun 2021
- First submitted
- 15 May 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT04402554
- Acronym / sponsor ID
- CannabisRIC / RNI 2020 MATHIEU
- Keywords
- Cannabis, Cannabis/therapeutic use, Cannabis/therapy, Medical Marijuana, Chronic Pain, Rheumatic Diseases, Arthritis, Rheumatoid, Spondylitis, Ankylosing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 27 May 2020 (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.
Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis.
The aim of this study is to assess the percentage of patients who use cannabis to better relieve their pain or anxiety in chronic inflammatory rheumatism.
Detailed description
Thanks to a better understanding of the pathophysiological mechanisms of inflammatory rheumatism, rheumatology has known for several decades a growth in its therapeutic arsenal (csDMARDs, bDMARDs, tDMARDs). rheumatism control has thus been optimized.
however, patients very often keep pain, anxiety, residual fatigue, poorly controlled by our conventional therapies. patients then turn to non-drug therapies, among which the use of cannabis.
endocannabinoids have an analgesic and anti-inflammatory action recognized in pre-clinical trials. however, investigators currently lack the data to authorize its use in clinical rheumatology.
the aim of this study is to determine the prevalence of cannabis users in patients with rheumatoid arthritis, ankylosing spondyloarthritis or psoriatic arthritis in our unit. as a second intention, investigators will refine the consumption characteristics. Investigators will also look for possible risk factors for consumption (sensitivity to pain, catastrophism, standard of living, anxiety, depression, rheumatic activity and quality of life).
Study design
- Observational model
- Cohort
- Time perspective
- Other
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, whether rheumatoid arthritis or spondyloarthritis, seen in consultation in the department of Rheumatology
Key inclusion criteria (3 listed)
- Rheumatoid Arthritis (ACR 2010 Criteria)
- Ankylosing Spondylitis (New york or ASAS criteria)
- Psoriatic Arthritis (CASPAR criteria)
Key exclusion criteria (2 listed)
- Patient unable to complete questionnaires or unable to express informed consent
- Guardianship, trusteeship, deprivation of liberties, safeguard of justice
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 |
|---|---|---|
| Cannabis questionnaireThe effectiveness and use of cannabis in the management of chronic pain has been well known for many years, but has so far been illegal and therefore largely unacknowledged. We hypothesize that the use of cannabis in this population of patients with chronic joint or spinal pain is not anecdotal and responds to a need to further improve the overall management of patients. The objective of our anonymous questionnaire is to estimate the prevalence of cannabis use in patients with chronic inflammatory rheumatism. | Behavioural | – |
Primary outcome
prevalence of cannabis use in patients with chronic inflammatory rheumatic conditions
Time frame: Day 0
Patients will answer the following question: Are you currently using cannabis - Yes or No
7 secondary outcomes
Percentage of patients with problematic cannabis use
Time frame: Day 0
Assessing the association between cannabis use and disease activity of spondylitis ankylosing
Time frame: Day 0
Assessing the association between cannabis use and disease activity of rheumatoid arthritis / psoriatic arthritis
Time frame: Day 0
Assessing the association between cannabis use and functional disability
Time frame: Day 0
Assessing the association between cannabis use and Anxiety/Depression
Time frame: Day 0
Assessing the association between cannabis use and pain catastrophism
Time frame: Day 0
Assessing the association between cannabis use and social vulnerability
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 2 Jun 2021.
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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.
Sylvain Mathieu principal investigator
University Hospital, Clermont-Ferrand
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 Rheumatoid Arthritis and Ankylosing Spondylitis, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 2 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 2 Jun 2021. 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?
prevalence of cannabis use in patients with chronic inflammatory rheumatic conditions (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 2 Jun 2021.