Rheumatoid ArthritisPhase 1NCT04911127
Therapeutic Response of Cannabidiol in Rheumatoid Arthritis
A Phase 1 study testing 200mg Cannabidiol by capsules twice daily and 400mg Cannabidiol by capsules twice daily in people with Rheumatoid Arthritis and Cannabis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The study will randomly assign Rheumatoid Arthritis (RA) patients on stable RA therapy to either placebo or cannabidiol (CBD). The overall goal of this proposal is to examine the efficacy and safety of CBD treatment as adjunctive to the medical management of RA patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Cannabis
- What is being tested?
- 200mg Cannabidiol by capsules twice daily and 400mg Cannabidiol by capsules twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 31 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 Classification Criteria for Rheumatoid Arthritis
- Disease activity score (DAS28) >= 3.2
- Age >= 18
- Stable RA therapy for 12 weeks prior to baseline
- Power Doppler Score >= 5 (for the PDUS 34 joint score)
- Must use at least one highly effective method of contraception
- Written informed consent
Who cannot join
- Prior exposure to cannabis <= 28 days prior to baseline
- Current diagnosed substance use disorders (including Alcohol Use Disorder)
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Chronic infections
- >10mg of prednisone daily use
- Daily use of central nervous system (CNS) depressant medications (e.g. sedatives, hypnotics [zolpidem, temazepam, alprazolam, lorazepam, diphenhydramine etc.])
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- Women who are pregnant, planning to become pregnant, or breast feeding
- Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception
- Deemed unsafe by the investigator
- History of an allergic reaction or adverse reaction to cannabis is exclusionary.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, 90095
About this study
Official title: Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis
The study will randomly assign Rheumatoid Arthritis (RA) patients on stable RA therapy to either placebo or cannabidiol (CBD). The overall goal of this proposal is to examine the efficacy and safety of CBD treatment as adjunctive to the medical management of RA patients.
Read the detailed description
This is a randomized, placebo-controlled, double-blind clinical trial at the University of California, Los Angeles evaluating the efficacy, safety, and tolerability of oral cannabidiol (CBD) as adjunctive for rheumatoid arthritis (RA) patients on stable therapy. Patients with moderate to severe RA meeting study inclusion criteria will be randomly assigned to one of three treatment groups (CBD 200 mg BID, CBD 400 mg BID, or placebo). Patients in all groups will receive CBD or placebo under observation for 12 weeks with an additional follow-up phone call occurring 4 weeks after.
- Conditions
- Rheumatoid Arthritis, Cannabis
- Being tested
- 200mg Cannabidiol by capsules twice daily, 400mg Cannabidiol by capsules twice daily, Placebo capsules
- Medical subject headings
- Arthritis, Rheumatoid, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200mg Cannabidiol by capsules twice dailyDrug
Also called CBD
200mg twice daily via 50mg capsules
400mg Cannabidiol by capsules twice dailyDrug
Also called CBD
400mg twice daily via 50mg capsules
Placebo capsulesDrug
Also called Placebo
MCT oil capsules as placebo for CBD
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will take capsules containing medium chain triglyceride (MCT) oil Receives: Drug: Placebo capsules |
| 200mg CBD twice daily | Experimental | Participants will take capsules containing cannabidiol amounting to 200mg CBD twice daily Receives: Drug: 200mg Cannabidiol by capsules twice daily |
| 400 mg CBD twice daily | Experimental | Participants will take capsules containing cannabidiol amounting to 400mg CBD twice daily Receives: Drug: 400mg Cannabidiol by capsules twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Disease Activity Score (DAS28/ESR)
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.
Measured: Baseline, 12 Weeks
Tolerability as assessed by participant attrition
Tolerability will be evaluated based on the number of participants that drop out due to treatment emergent adverse events or serious adverse events.
Measured: 12 weeks
Secondary outcomes (2)
Change in Power Doppler Synovitis Score (PDUS)
34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. PDUS ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for PDUS represents more severe disease level.
Measured: Baseline, 12 weeks
Change in Grey Scale Synovial Hypertrophy Score (GSUS)
34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. GSUS ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for GSUS represents more severe disease level.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start5 Oct 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veena Ranganath, MD, MS, University of California, Los Angeles
- Investigators
- Ziva Cooper, PhD, Principal investigator, University of California, Los AngelesVeena Ranganath, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911127
- Sponsor's protocol ID
- 19-01551
- Other IDs
- P64-01-003
- Status last verified
- Jun 2024
- First submitted
- 14 May 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04911127
- Acronym / sponsor ID
- 19-01551
- Conditions
- Rheumatoid Arthritis, Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Jun 2021 (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.
The study will randomly assign Rheumatoid Arthritis (RA) patients on stable RA therapy to either placebo or cannabidiol (CBD). The overall goal of this proposal is to examine the efficacy and safety of CBD treatment as adjunctive to the medical management of RA patients.
Detailed description
This is a randomized, placebo-controlled, double-blind clinical trial at the University of California, Los Angeles evaluating the efficacy, safety, and tolerability of oral cannabidiol (CBD) as adjunctive for rheumatoid arthritis (RA) patients on stable therapy. Patients with moderate to severe RA meeting study inclusion criteria will be randomly assigned to one of three treatment groups (CBD 200 mg BID, CBD 400 mg BID, or placebo). Patients in all groups will receive CBD or placebo under observation for 12 weeks with an additional follow-up phone call occurring 4 weeks after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo capsulesParticipants will take capsules containing medium chain triglyceride (MCT) oil |
| 200mg CBD twice daily | Experimental | Drug: 200mg Cannabidiol by capsules twice dailyParticipants will take capsules containing cannabidiol amounting to 200mg CBD twice daily |
| 400 mg CBD twice daily | Experimental | Drug: 400mg Cannabidiol by capsules twice dailyParticipants will take capsules containing cannabidiol amounting to 400mg CBD twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 Classification Criteria for Rheumatoid Arthritis
- Disease activity score (DAS28) >= 3.2
- Age >= 18
- Stable RA therapy for 12 weeks prior to baseline
- Power Doppler Score >= 5 (for the PDUS 34 joint score)
Key exclusion criteria (10 listed)
- Prior exposure to cannabis <= 28 days prior to baseline
- Current diagnosed substance use disorders (including Alcohol Use Disorder)
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Chronic infections
- >10mg of prednisone daily use
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 |
|---|---|---|
| 200mg Cannabidiol by capsules twice dailyAlso: CBD200mg twice daily via 50mg capsules | Drug | 200mg CBD twice daily |
| 400mg Cannabidiol by capsules twice dailyAlso: CBD400mg twice daily via 50mg capsules | Drug | 400 mg CBD twice daily |
| Placebo capsulesAlso: PlaceboMCT oil capsules as placebo for CBD | Drug | Placebo |
Primary outcome
Change from Baseline in Disease Activity Score (DAS28/ESR)
Time frame: Baseline, 12 Weeks
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.
Tolerability as assessed by participant attrition
Time frame: 12 weeks
Tolerability will be evaluated based on the number of participants that drop out due to treatment emergent adverse events or serious adverse events.
2 secondary outcomes
Change in Power Doppler Synovitis Score (PDUS)
Time frame: Baseline, 12 weeks
Change in Grey Scale Synovial Hypertrophy Score (GSUS)
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Ziva Cooper, PhD principal investigator
University of California, Los Angeles
Veena Ranganath, MD, MS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 200mg Cannabidiol by capsules twice daily and 400mg Cannabidiol by capsules twice daily in people with Rheumatoid Arthritis and Cannabis, run by University of California, Los Angeles 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 7 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline in Disease Activity Score (DAS28/ESR) (time frame: Baseline, 12 Weeks). The study lists 2 primary outcomes in all. 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 7 Jun 2024.