Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

University of California, Los Angeles67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rheumatoid Arthritis Cannabis

Interventions

200mg Cannabidiol by capsules twice dailyDRUG

200mg twice daily via 50mg capsules

400mg Cannabidiol by capsules twice dailyDRUG

400mg twice daily via 50mg capsules

Placebo capsulesDRUG

MCT oil capsules as placebo for CBD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 \[zolpidem, temazepam, alprazolam, lorazepam, diphenhydramine etc.\]) * 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.

Locations (1)

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline, 12 weeks

Data from ClinicalTrials.gov

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