Clinical trial NCT03693833: CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.
Official title: CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Hand Osteoarthritis
Keywords: Cannabidiol
Cannabis
Osteoarthritis
Psoriatic arthritis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2018-10-03
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

1. Percentage of patients experiencing adverse events (AE)
2. A characterization of serious adverse events (SAE)

Exploratory outcomes

1. Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group.
2. Correlation between baseline quantitative sensory testing (QST) and treatment effect after 12 weeks.
3. Difference in QST change between the intervention and placebo group after 12 weeks of treatment.
4. Correlation between baseline psychosocial parameters, patient reported outcomes (PROMs) and treatment effect.
5. 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.

Eligibility criteria: Inclusion Criteria Hand-OA:

* 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.

Inclusion criteria PsA

* 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.

Exclusion Criteria:

* 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.
* 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).

Primary outcomes:
measure: VAS pain during the last 24 hours
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
Other outcomes:
measure: Patients experiencing adverse events
timeFrame: 24 weeks
measure: Characterization of serious adverse events
timeFrame: 24 weeks
measure: Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group.
timeFrame: at 24week followup
measure: Correlation between baseline quantitative sensory testing (QST) and treatment effect after 12 weeks.
timeFrame: at 12week visit
measure: Correlation between baseline psychosocial parameters, patient reported outcomes (PROMs) and treatment effect
timeFrame: at 12 week visit
measure: 5. Difference in changes of the psychosocial parameters and PROMs between the intervention and control group after 12 weeks of treatment
timeFrame: at 12 week visit
Locations:
city: Aalborg
country: Denmark
facility: Department of Rheumatology Aalborg Universityhospital North
Study officials:
affiliation: Dept. of rheumatology Aalborg University Hospital
name: Jonathan Vela
role: PRINCIPAL_INVESTIGATOR
References: