Psoriatic ArthritisPhase 2NordCANNCT03693833
CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.
A Phase 2 study testing Cannabidiol in people with Psoriatic Arthritis and Hand Osteoarthritis, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis, Hand Osteoarthritis
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Nov 2018to 1 Jun 2021
- Phase
- Phase 2
- 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
- Patients (18 years or more) with Hand-OA according to the American Collage of Rheumatology (ACR) criteria (1990)
- Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
- VAS pain during the last 24 hours 30mm or more
- Negative pregnancy test (serum HCG) prior to trial start (for women of childbearing potential) and the use of contraception throughout the study period and for 3 months after conclusion of the study period for males and females of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrolment.
- Patients (18 years or more) with PsA according to the Calcification Criteria for Psoriatic Arthritis (CASPAR) criteria (2006)
- Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
- VAS pain during the last 24 hours 30mm or more
- Negative pregnancy test (serum human chorionic gonadotropin (HCG)) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrolment.
Who cannot join
- Concurrent diagnosis of chronic regional pain syndrome or neuropathy
- Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout not in remission)
- Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowel disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
- Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)
- Planned major surgery or recent major surgery (last 8weeks)
- Addictive behaviour or previously addictive behaviour defined as abuse of cannabis, opioids or other recreational or pharmaceutical drugs. Determined through patient interview and medical records.
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- Contraindication to medical cannabis (Known allergy to ingredients, history of severe liver or kidney disease, history of schizophrenia or other serious psychiatric disease).
- Verified malignant disease
- History of epilepsy or severe cramps
- History of serious cardiovascular pathology
- Lacking ability to corporate with the research staff.
- Indication for changing the anti-inflammatory treatment regimen at baseline (PsA only).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Rheumatology Aalborg Universityhospital North
Aalborg, 9000
About this study
Official title: CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.
Read the detailed description
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.
Aim: To assess the effect of CBD on visual analogue scale pain measurements at 12 weeks compared with placebo.
Patients and controls: Patients with Hand-OA or PsA and VASpain during the last 24hours of 30mm or more.
Primary outcome: Changes in VAS pain during the last 24 hours from baseline to 12 weeks. Measured with a 100mm VAS from the most symptomatic hand (Hand-OA) or joint (PsA).
Safety outcomes
- Percentage of patients experiencing adverse events (AE)
- A characterization of serious adverse events (SAE)
Exploratory outcomes
- Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group.
- Correlation between baseline quantitative sensory testing (QST) and treatment effect after 12 weeks.
- Difference in QST change between the intervention and placebo group after 12 weeks of treatment.
- Correlation between baseline psychosocial parameters, patient reported outcomes (PROMs) and treatment effect.
- Difference in changes of the psychosocial parameters and PROMs between the intervention and control group after 12 weeks of treatment
Intervention: 10mg CBD tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.
The medicine and placebo will be delivered and produced by Glostrup pharmacy.
Examination programme: All participants will receive a full medical interview and a physical examination which includes auscultation, blood pressure, heart rate and saturation measurements and BMI calculation. All participants will have blood drawn for later examination for markers of inflammation and degeneration. All participants will go through Quantitative Sensory Testing (QST). QST covers a wide range of different examinations techniques used to assess the functional status of the somatosensory system. In the present study pressure algometry and cuff algometry will be performed.
Pain phenotyping: Participants will answer a series of questionnaires related to the pain experience to assess: Anxiety and depression (the hospital anxiety and depression scale), pain catastrophizing (the pain catastrophizing scale), pain description (The short form McGill questionnaire and pain detect questionnaire), sleep quality (Pittsburgh sleep quality index) and a Widespread Pain Assessment questionnaire and the Symptom Severity Index. To assess function and quality of life the Short form 36 and Health assessment questionnaire will be used.
Patients with PsA: Will receive an examination for disease specific tests including: joint tenderness and swelling using the EULAR66/68 regiment, dactylitis evaluation using Leeds dactylitis index basic, skin involvement using the psoriasis area and severity index and nail psoriasis via nail psoriasis severity index.
Patients with Hand-OA: Will receive the following disease specific examinations evaluation of tender and swollen joints of the hands and wrists. Grip and pinch strength measurements using a hand-held dynamometer and the functional index of hand-osteoarthritis.
The trial consists of a screening visit, a baseline visit where the patient will undergo randomization, a phone consultation after 4 weeks a blood and urin sample after 6 weeks. and an end of trial visit at week 12. Patients will be invited to a follow-up visit at week 24.
Patients will be asked for adverse events at each visit and these are recorded in the eCRF.
- Conditions
- Psoriatic Arthritis, Hand Osteoarthritis
- Being tested
- Cannabidiol, Placebo Oral Tablet
- Keywords
- Cannabidiol, Cannabis, Osteoarthritis, Psoriatic arthritis
- Medical subject headings
- Arthritis, Psoriatic, Marijuana Abuse, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
Cannabidiol (CBD) tablets of 10mg each
Placebo Oral TabletDrug
Also called Oral Placebo
Oral Placebo tablets of 10mg each
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 10mg Cannabidiol (CBD) tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | 10mg Placebo Oral tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain during the last 24 hours
Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start28 Nov 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Jonathan Vela, Aalborg University Hospital
- Investigators
- Jonathan Vela, Principal investigator, Dept. of rheumatology Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693833
- Sponsor's protocol ID
- NordCAN
- Acronym
- NordCAN
- Status last verified
- Jul 2021
- First submitted
- 1 Oct 2018
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03693833
- Acronym / sponsor ID
- NordCAN / NordCAN
- Conditions
- Psoriatic Arthritis, Hand Osteoarthritis
- Keywords
- Cannabidiol, Cannabis, Osteoarthritis, Psoriatic arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 3 Oct 2018 (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.
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.
Detailed description
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.
Aim: To assess the effect of CBD on visual analogue scale pain measurements at 12 weeks compared with placebo.
Patients and controls: Patients with Hand-OA or PsA and VASpain during the last 24hours of 30mm or more.
Primary outcome: Changes in VAS pain during the last 24 hours from baseline to 12 weeks. Measured with a 100mm VAS from the most symptomatic hand (Hand-OA) or joint (PsA).
Safety outcomes
- Percentage of patients experiencing adverse events (AE)
- A characterization of serious adverse events (SAE)
Exploratory outcomes
- Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group.
- Correlation between baseline quantitative sensory testing (QST) and treatment effect after 12 weeks.
- Difference in QST change between the intervention and placebo group after 12 weeks of treatment.
- Correlation between baseline psychosocial parameters, patient reported outcomes (PROMs) and treatment effect.
- Difference in changes of the psychosocial parameters and PROMs between the intervention and control group after 12 weeks of treatment
Intervention: 10mg CBD tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.
The medicine and placebo will be delivered and produced by Glostrup pharmacy.
Examination programme: All participants will receive a full medical interview and a physical examination which includes auscultation, blood pressure, heart rate and saturation measurements and BMI calculation. All participants will have blood drawn for later examination for markers of inflammation and degeneration. All participants will go through Quantitative Sensory Testing (QST). QST covers a wide range of different examinations techniques used to assess the functional status of the somatosensory system. In the present study pressure algometry and cuff algometry will be performed.
Pain phenotyping: Participants will answer a series of questionnaires related to the pain experience to assess: Anxiety and depression (the hospital anxiety and depression scale), pain catastrophizing (the pain catastrophizing scale), pain description (The short form McGill questionnaire and pain detect questionnaire), sleep quality (Pittsburgh sleep quality index) and a Widespread Pain Assessment questionnaire and the Symptom Severity Index. To assess function and quality of life the Short form 36 and Health assessment questionnaire will be used.
Patients with PsA: Will receive an examination for disease specific tests including: joint tenderness and swelling using the EULAR66/68 regiment, dactylitis evaluation using Leeds dactylitis index basic, skin involvement using the psoriasis area and severity index and nail psoriasis via nail psoriasis severity index.
Patients with Hand-OA: Will receive the following disease specific examinations evaluation of tender and swollen joints of the hands and wrists. Grip and pinch strength measurements using a hand-held dynamometer and the functional index of hand-osteoarthritis.
The trial consists of a screening visit, a baseline visit where the patient will undergo randomization, a phone consultation after 4 weeks a blood and urin sample after 6 weeks. and an end of trial visit at week 12. Patients will be invited to a follow-up visit at week 24.
Patients will be asked for adverse events at each visit and these are recorded in the eCRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Cannabidiol10mg Cannabidiol (CBD) tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward. |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet10mg Placebo Oral tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients (18 years or more) with Hand-OA according to the American Collage of Rheumatology (ACR) criteria (1990)
- Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
- VAS pain during the last 24 hours 30mm or more
- Negative pregnancy test (serum HCG) prior to trial start (for women of childbearing potential) and the use of contraception throughout the study period and for 3 months after conclusion of the study period for males and females of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrolment.
- Patients (18 years or more) with PsA according to the Calcification Criteria for Psoriatic Arthritis (CASPAR) criteria (2006)
Key exclusion criteria (12 listed)
- Concurrent diagnosis of chronic regional pain syndrome or neuropathy
- Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout not in remission)
- Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowel disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
- Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)
- Planned major surgery or recent major surgery (last 8weeks)
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 |
|---|---|---|
| CannabidiolAlso: CBDCannabidiol (CBD) tablets of 10mg each | Drug | Intervention |
| Placebo Oral TabletAlso: Oral PlaceboOral Placebo tablets of 10mg each | Drug | Placebo |
Primary outcome
VAS pain during the last 24 hours
Time frame: Change from baseline to 12 weeks
Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.
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 7 Jul 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.
Jonathan Vela principal investigator
Dept. of rheumatology Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Psoriatic Arthritis and Hand Osteoarthritis, run by Aalborg University Hospital at 1 site in Denmark.
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 8 inclusion and 12 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 7 Jul 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 Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
VAS pain during the last 24 hours (time frame: Change from baseline to 12 weeks). 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 7 Jul 2021.