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| ID | Type | Description | Link |
|---|---|---|---|
| P64-01-003 | Other Grant/Funding Number | CMCR |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will take capsules containing medium chain triglyceride (MCT) oil |
|
| 200mg CBD twice daily | Experimental | Participants will take capsules containing cannabidiol amounting to 200mg CBD twice daily |
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| 400 mg CBD twice daily | Experimental | Participants will take capsules containing cannabidiol amounting to 400mg CBD twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 200mg Cannabidiol by capsules twice daily | Drug | 200mg twice daily via 50mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory cytokine and chemokine concentrations | Inflammatory cytokines and chemokine concentrations from plasma will be evaluated using multiplex cytokine array. | Baseline, 12 weeks |
| Change in white blood cell (WBC) subset percentages |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziva Cooper, PhD | University of California, Los Angeles | Principal Investigator |
| Veena Ranganath, MD, MS | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 400mg Cannabidiol by capsules twice daily | Drug | 400mg twice daily via 50mg capsules |
|
|
| Placebo capsules | Drug | MCT oil capsules as placebo for CBD |
|
|
| 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. | Baseline, 12 weeks |
WBC subset percentages will be assessed via flow cytometry.
| Baseline, 12 weeks |
| Change in Clinical Disease Activity Index (CDAI) | CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range is 0-76, where higher scores indicate increased disease activity. | Baseline, 12 weeks |
| Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability. | Baseline, 12 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |