Therapeutic Response of Cannabidiol in Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT04911127|
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : October 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Cannabis||Drug: 200mg Cannabidiol by capsules twice daily Drug: 400mg Cannabidiol by capsules twice daily Drug: Placebo capsules||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis|
|Actual Study Start Date :||October 5, 2021|
|Estimated Primary Completion Date :||June 10, 2024|
|Estimated Study Completion Date :||June 10, 2025|
Placebo Comparator: Placebo
Participants will receive capsules containing medium chain triglyceride (MCT) oil
Drug: Placebo capsules
MCT oil capsules as placebo for CBD
|Experimental: 200mg CBD twice daily||
Drug: 200mg Cannabidiol by capsules twice daily
200mg twice daily via 50mg capsules
|Experimental: 400 mg CBD twice daily||
Drug: 400mg Cannabidiol by capsules twice daily
400mg twice daily via 50mg capsules
- 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.
- Change in Power Doppler Synovitis Score (PDUS) [ Time Frame: Baseline, 12 weeks ]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.
- Change in Grey Scale Synovial Hypertrophy Score (GSUS) [ Time Frame: Baseline, 12 weeks ]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.
- Change in inflammatory cytokine and chemokine concentrations [ Time Frame: Baseline, 12 weeks ]Inflammatory cytokines and chemokine concentrations from plasma will be evaluated using multiplex cytokine array.
- Change in white blood cell (WBC) subset percentages [ Time Frame: Baseline, 12 weeks ]WBC subset percentages will be assessed via flow cytometry.
- Change in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline, 12 weeks ]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.
- Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Baseline, 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04911127
|Contact: Nicolette Morris, BS||310-825-9956||NTMorris@mednet.ucla.edu|
|United States, California|
|UCLA David Geffen School of Medicine, Division of Rheumatology||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Nicolette Morris 310-825-9956|
|Principal Investigator: Veena K Ranganath, M.D.|
|Principal Investigator: Ziva Cooper, PhD|
|Principal Investigator:||Ziva Cooper, PhD||University of California, Los Angeles|
|Principal Investigator:||Veena Ranganath, MD, MS||University of California, Los Angeles|