Rheumatoid ArthritisNCT06513507
A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.
A study testing Cannabigerol (CBG) in people with Rheumatoid Arthritis and Inflammatory Disease, run by Raphael Pharma at 1 site in United States.
Trial summary
This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Inflammatory Disease
- What is being tested?
- Cannabigerol (CBG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, over 25 years of age
- Positive anti-CCP blood test
- Active RA-related inflammation with at least 2 swollen joints
- University graduate
- Generally healthy with no uncontrolled chronic disease
- Able to read, understand, and sign informed consent
- Resides in the USA
- Willing to comply with study requirements and avoid other cannabis products during the study period
Who cannot join
- Pre-existing chronic conditions preventing adherence
- Severe allergic reactions requiring an Epi-pen
- Use of opiates in the last 4 weeks or cannabis in the last 8 weeks
- Pregnant or breastfeeding women
- Recent invasive medical procedure or surgery
- Active malignancy or ongoing oncology treatment
- Use of cytochrome P450 or 3A4 inhibitors
- History of substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.
- Conditions
- Rheumatoid Arthritis, Inflammatory Disease
- Being tested
- Cannabigerol (CBG)
- Keywords
- Arthritis Treatment, Cannabinoid Therapy, Anti-CCP
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabigerol (CBG)Dietary supplement
The daily dose will consist of 50 mg of CBG. Blood tests will be conducted at Baseline, Week 2, Week 4, Week 6, and Week 8 to monitor inflammatory markers and immune response. Self-reported questionnaires will be completed at Baseline, Week 4, and Week 8 to assess symptoms and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| CBG Treatment | Experimental | Participants will receive 0.5 milliliters of purified cannabigerol (CBG) in sesame oil once daily in the evening for a duration of eight weeks. Receives: Dietary Supplement: Cannabigerol (CBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory markers from Baseline to Week 8
Measurement of blood levels of ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein), IL6 (Interleukin 6), and TNFa (Tumor Necrosis Factor-alpha) at Baseline, Week 2, Week 4, Week 6, and Week 8.
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes (1)
Change in self-reported symptoms and quality of life from Baseline to Week 8
Evaluation of participant perceptions of the product's effect on symptoms of rheumatoid arthritis and quality of life using a study-specific questionnaire.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start3 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group study with an exploratory longitudinal prospective design aimed at measuring the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raphael Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513507
- Sponsor's protocol ID
- 20441
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT06513507
- Acronym / sponsor ID
- 20441
- Conditions
- Rheumatoid Arthritis, Inflammatory Disease
- Keywords
- Arthritis Treatment, Cannabinoid Therapy, Anti-CCP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Raphael PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group study with an exploratory longitudinal prospective design aimed at measuring the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis.
| Arm | Type | Receives |
|---|---|---|
| CBG Treatment | Experimental | Dietary Supplement: Cannabigerol (CBG)Participants will receive 0.5 milliliters of purified cannabigerol (CBG) in sesame oil once daily in the evening for a duration of eight weeks. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, over 25 years of age
- Positive anti-CCP blood test
- Active RA-related inflammation with at least 2 swollen joints
- University graduate
- Generally healthy with no uncontrolled chronic disease
Key exclusion criteria (8 listed)
- Pre-existing chronic conditions preventing adherence
- Severe allergic reactions requiring an Epi-pen
- Use of opiates in the last 4 weeks or cannabis in the last 8 weeks
- Pregnant or breastfeeding women
- Recent invasive medical procedure or surgery
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 |
|---|---|---|
| Cannabigerol (CBG)The daily dose will consist of 50 mg of CBG. Blood tests will be conducted at Baseline, Week 2, Week 4, Week 6, and Week 8 to monitor inflammatory markers and immune response. Self-reported questionnaires will be completed at Baseline, Week 4, and Week 8 to assess symptoms and quality of life. | Dietary supplement | CBG Treatment |
Primary outcome
Change in inflammatory markers from Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Measurement of blood levels of ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein), IL6 (Interleukin 6), and TNFa (Tumor Necrosis Factor-alpha) at Baseline, Week 2, Week 4, Week 6, and Week 8.
1 secondary outcome
Change in self-reported symptoms and quality of life from Baseline to Week 8
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabigerol (CBG) in people with Rheumatoid Arthritis and Inflammatory Disease, run by Raphael Pharma at 1 site in United States.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in inflammatory markers from Baseline to Week 8 (time frame: Baseline, Week 2, Week 4, Week 6, and Week 8). 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 21 Nov 2024.