Clinical trial NCT04911127: Therapeutic Response of Cannabidiol in Rheumatoid Arthritis
Official title: Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Cannabis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Disease Activity Score (DAS28/ESR)
timeFrame: Baseline, 12 Weeks
measure: Tolerability as assessed by participant attrition
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Power Doppler Synovitis Score (PDUS)
timeFrame: Baseline, 12 weeks
measure: Change in Grey Scale Synovial Hypertrophy Score (GSUS)
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Change in inflammatory cytokine and chemokine concentrations
timeFrame: Baseline, 12 weeks
measure: Change in white blood cell (WBC) subset percentages
timeFrame: Baseline, 12 weeks
measure: Change in Clinical Disease Activity Index (CDAI)
timeFrame: Baseline, 12 weeks
measure: Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Baseline, 12 weeks
Locations:
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine, Division of Rheumatology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ziva Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Veena Ranganath, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: