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Trial registered on ANZCTR


Registration number
ACTRN12624001378516
Ethics application status
Approved
Date submitted
3/11/2024
Date registered
20/11/2024
Date last updated
20/11/2024
Date data sharing statement initially provided
20/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial of the preliminary effectiveness of topical cannabidiol (CBD) on function, joint pain and swelling, and inflammation in adults with rheumatoid arthritis
Scientific title
An open label clinical trial investigating the preliminary effectiveness of a topical cannabidiol (CBD) roll-on salve on functional status, joint pain and swelling, and inflammation in adults with rheumatoid arthritis (RA).
Secondary ID [1] 313286 0
H16105
Universal Trial Number (UTN)
Trial acronym
OMG-Arthritis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 335623 0
Condition category
Condition code
Inflammatory and Immune System 332181 332181 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical cannabidiol (OMG Unwind 2600mg Salve) containing 100% CBD isolate as the Active Pharmaceutical Ingredient (API) with a broad range of excipients. (Total cannabinoid content is 2600mg of CBD in 56g tube. 46mg/g), applied to affected joints twice a day for 28 days. There is no prescribed amount to be administered each time as the instructions are to roll the salve on in a circular motion in the affected area and then gently rub in. There is no minimum time for the salve to remain on affected joints. Adherence will be assessed via a daily medication log.
Intervention code [1] 329862 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339768 0
Functional status
Timepoint [1] 339768 0
Baseline, End of treatment (day 28)
Secondary outcome [1] 441213 0
Joint pain
Timepoint [1] 441213 0
Baseline, End of treatment (Day 28)
Secondary outcome [2] 441214 0
Health-related quality of life
Timepoint [2] 441214 0
Baseline, End of treatment (Day 28)
Secondary outcome [3] 441215 0
Tender Joint Count
Timepoint [3] 441215 0
Baseline, End of treatment (Day 28)
Secondary outcome [4] 441216 0
Swollen Joint Count
Timepoint [4] 441216 0
Baseline, End of treatment (Day 28)
Secondary outcome [5] 441217 0
Disease Activity
Timepoint [5] 441217 0
Baseline, End of treatment (Day 28)
Secondary outcome [6] 441218 0
Wellbeing
Timepoint [6] 441218 0
Baseline, End of treatment (Day 28)
Secondary outcome [7] 441219 0
Inflammatory markers (Erythrocyte Sedimentation Rate/ESR)
Timepoint [7] 441219 0
Baseline, End of treatment (Day 28)
Secondary outcome [8] 441220 0
Medication use
Timepoint [8] 441220 0
Daily between Day 1 (first day of treatment) and Day 28 post start of treatment
Secondary outcome [9] 441221 0
Adverse events (participant self-reported and also investigator collected on an adverse event form). Known/possible adverse events are headaches and rash.
Timepoint [9] 441221 0
Between Day 1 (first day of treatment) and Day 42 post start of treatment
Secondary outcome [10] 441222 0
Participant Satisfaction
Timepoint [10] 441222 0
Day 42 post start of treatment
Secondary outcome [11] 441223 0
Safety - impact on haematological function
Timepoint [11] 441223 0
Day 28 post start of treatment
Secondary outcome [12] 441686 0
Safety - impact on hepatic function
Timepoint [12] 441686 0
Day 28 post start of treatment
Secondary outcome [13] 441687 0
Safety - impact on renal function
Timepoint [13] 441687 0
Day 28 post start of treatment
Secondary outcome [14] 441963 0
C-reactive protein
Timepoint [14] 441963 0
Baseline, End of treatment (Day 28)

Eligibility
Key inclusion criteria
Inclusion criteria:
• I1: Adult aged 18 years and over
• I2: Able to provide informed consent, comprehend and follow all study procedures.
• I:3 Medically diagnosed with Rheumatoid arthritis with at least 4 affected joints.
• I:4 Able and willing to have safety blood samples collected at a Laverty pathology collection centre before the baseline and after the endpoint visit.
• I5: Agrees to not start using any medical or recreational cannabis during the 4-week study period and 2 week follow up period.
• I6: Resides in NSW and can travel to NICM Health Research Institute in Westmead.
• I7: Experiences joint pain, discomfort, or fatigue, is dissatisfied with current treatment, and looking for alternative options to manage these symptoms.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• E1: Currently using medicinal or recreational cannabis or have used within the last 3 months.
• E2: If female, currently pregnant or planning to become pregnant over the study intervention period.
• E3: History of moderate to severe psychological or other mental health conditions.
• E4: History of substance use disorder (alcohol, tobacco, cannabis, and other legal, illicit or prescription substances like opioids and benzodiazepines).
• E5: Have started using new medication (such as DMARDs, NSAIDs, CS, Opioids, Benzodiazepines, or anti-depressants) within the last 3 months to manage RA.
• E6: Participant has any form of surgery booked within 4 weeks of baseline (Day0) and 4 weeks after follow-up (day 42).
• E7: Travel outside of NSW during intervention period.
• E8: Diagnosis of dementia.
• E9: Participants with known allergies to any ingredients in the salve.
• E10: Participants with significant dermatological conditions affecting the intended application site/s.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is an open label study with only one treatment arm, a within subjects, repeated measures design, descriptive statistics, and linear mixed model analysis will be sufficient to determine statistically significant differences in primary (HAQ-II) and secondary endpoint measures (Pain_VAS, PGA_VAS, SJC, TJC, DAS-28, PROMIS-29, CRP, and ESR) across baseline, endpoint and follow up adjusting for confounders including duration of disease, comorbidity index and other demographic and medical characteristics.

Chi-square analysis will be used to evaluate frequency data relating to adverse events, medication use, and Exit interview responses. p-values will be reported with 95% confidence intervals. Data will be analysed using SPSS

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2024
Actual
Date of last participant enrolment
Anticipated
25/05/2025
Actual
Date of last data collection
Anticipated
10/07/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317737 0
Commercial sector/Industry
Name [1] 317737 0
OMG Pharma
Country [1] 317737 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OMG Pharma
Address
Country
Australia
Secondary sponsor category [1] 320050 0
None
Name [1] 320050 0
Address [1] 320050 0
Country [1] 320050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316425 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 316425 0
https://www.westernsydney.edu.au/research/research_ethics_and_integrity/human_ethics/apply_for_human_research_ethics_review
Ethics committee country [1] 316425 0
Australia
Date submitted for ethics approval [1] 316425 0
30/05/2024
Approval date [1] 316425 0
23/09/2024
Ethics approval number [1] 316425 0
H16105

Summary
Brief summary
The purpose of this study is to investigate the preliminary effectiveness and safety of a topical cannabidiol salve for rheumatoid arthritis. We hypothesise that using the salve for 4 weeks will have a clinically significant effect on functional status. This is an open label trial with all participants receiving the intervention for 4 weeks. Participants will apply the salve to affected joints twice daily for 28 days. The primary outcome is change in functional status. Secondary outcomes include health-related quality of life, pain, swollen and tender joint count, side effects, and change in inflammation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137850 0
A/Prof Carolyn Ee
Address 137850 0
NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith 2751, NSW
Country 137850 0
Australia
Phone 137850 0
+61413319830
Fax 137850 0
Email 137850 0
[email protected]
Contact person for public queries
Name 137851 0
David Varjabedian
Address 137851 0
NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith 2751, NSW
Country 137851 0
Australia
Phone 137851 0
+61402621742
Fax 137851 0
Email 137851 0
[email protected]
Contact person for scientific queries
Name 137852 0
Carolyn Ee
Address 137852 0
NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith 2751, NSW
Country 137852 0
Australia
Phone 137852 0
+61413319830
Fax 137852 0
Email 137852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.