A Phase 2 interventional study of Cannabidiol and Placebo Oral Tablet in Psoriatic Arthritis and Hand Osteoarthritis, sponsored by Aalborg University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Aalborg University Hospital · Phase 2, Interventional, and Treatment
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.
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
Exploratory outcomes
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 136 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.
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Inclusion Criteria Hand-OA:
Inclusion criteria PsA
Exclusion Criteria:
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.
Drug: Cannabidiol
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.
Drug: Placebo Oral Tablet
Cannabidiol (CBD) tablets of 10mg each
Also known as: CBD
Oral Placebo tablets of 10mg each
Also known as: Oral Placebo
VAS pain during the last 24 hours
Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.
Time frame: Change from baseline to 12 weeks
Patients experiencing adverse events
Percentage of patients experiencing adverse events in placebo and intervention group
Time frame: 24 weeks
Characterization of serious adverse events
Description of which serious adverse events where experience in each group
Time frame: 24 weeks
Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group.
Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.
Time frame: at 24week followup
Correlation between baseline quantitative sensory testing (QST) and treatment effect after 12 weeks.
QST measurements will include pain detection threshold, pain tolerance threshold, temporal summation and conditioned pain modulation
Time frame: at 12week visit
Correlation between baseline psychosocial parameters, patient reported outcomes (PROMs) and treatment effect
patient reported outcome includes: Expected effect of treatment is measured using the Stanford expectations scale. Pain catastrophizing thoughts are measured using the Pain catastrophizing scale. Presence of widespread pain is evaluated using the Widespread Pain Index and the Symptom Severity Scale. Sleep quality is evaluated using the Pittsburgh Sleep Quality Index. Presence of anxiety and depression is measured using the Hospital Anxiety and Depression Scale. Furthermore, pain phenotype will be quantified using the Pain Detect Questionnaire and Short Form McGill questionnaire. Quality of life is quantified using the Short form 36 and disability using the Health Assessment Questionnaire Disability Index and Functional index of hand osteoarthritis.
Time frame: at 12 week visit
5. Difference in changes of the psychosocial parameters and PROMs between the intervention and control group after 12 weeks of treatment
patient reported outcome includes: Expected effect of treatment is measured using the Stanford expectations scale. Pain catastrophizing thoughts are measured using the Pain catastrophizing scale. Presence of widespread pain is evaluated using the Widespread Pain Index and the Symptom Severity Scale. Sleep quality is evaluated using the Pittsburgh Sleep Quality Index. Presence of anxiety and depression is measured using the Hospital Anxiety and Depression Scale. Furthermore, pain phenotype will be quantified using the Pain Detect Questionnaire and Short Form McGill questionnaire. Quality of life is quantified using the Short form 36 and disability using the Health Assessment Questionnaire Disability Index and Functional index of hand osteoarthritis.
Time frame: at 12 week visit
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Aalborg University Hospital