Medical cannabis for the treatment of pain in patients with hand osteoarthritis and psoriatic arthritis.

Phase 1

• Conditions: Psoriatic ArthritisHand Osteoarthritis; MedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10019115Term: Hand osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-003574-13-DK
• Lead Sponsor: Aalborg university hospital dept. of rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-08
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Hand-OA:
Patients (18 years or older) with Hand-OA according to the American collage of rheumatology (ACR) criteria (1990)

Hand-OA of the phenotype: Nodal, Non-erosive.

Ability and willingness to give written informed consent and to meet the requirements of the study protocol.

100mm VAS pain during the last 24 hours over or equal to 30mm

PsA:

Patients (18 years or older) with PsA according to the classification criteria for psoriatic arthritis CASPAR criteria (2006)

Ability and willingness to give written informed consent and to meet the requirements of the study protocol.

100mm VAS pain during the last 24 hours over or equal to 30mm

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Hand-Oa and PsA
1.Other known inflammatory rheumatic disease (i.e. Rheumatoid arthritis, gout)
2.Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy)
3.Addictive behaviour or previously addictive behaviour defined as abuse of cannabis, opioids or other recreational or pharmaceutical drugs
4.History of psychiatric disease that contraindicates use of medical cannabis treatment (i.e. schizophrenia).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of cannabidiol (CBD) on pain in patients with nodal non-erosive hand osteoarthritis (Hand-OA) and psoriatic arthritis (PsA) after 12 weeks;Secondary Objective: oChanges is VAS pain during the last 24 hours from baseline to 24 weeks.<br>oChanges in VAS global from baseline to 12 weeks and 24 weeks.<br>oChanges in function scores from baseline to 12 weeks.<br>oChanges in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks.<br>oChanges in grip and pinch strength from baseline to 12 weeks* and 24 weeks (Hand-OA only).<br>oInflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks.<br>;Primary end point(s): Changes in VAS pain during the last 24 hours from baseline to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): oChanges is VAS pain during the last 24 hours from baseline to 24 weeks.<br>oChanges in VAS global from baseline to 12 weeks and 24 weeks.<br>oChanges in function scores from baseline to 12 and 24 weeks.<br>oChanges in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks.<br>oChanges in grip and pinch strength from baseline to 12 weeks* and 24 weeks*.<br>oInflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks and 24 weeks will be made.<br>;Timepoint(s) of evaluation of this end point: 12-24weeks