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Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis, Cannabis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
200mg Cannabidiol by capsules twice daily
400mg Cannabidiol by capsules twice daily
Placebo capsules
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA David Geffen School of Medicine, Division of RheumatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

200mg CBD twice daily

400 mg CBD twice daily

Arm Description

Participants will take capsules containing medium chain triglyceride (MCT) oil

Participants will take capsules containing cannabidiol amounting to 200mg CBD twice daily

Participants will take capsules containing cannabidiol amounting to 400mg CBD twice daily

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 14, 2021
Last Updated
November 4, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04911127
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
June 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Cannabis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take capsules containing medium chain triglyceride (MCT) oil
Arm Title
200mg CBD twice daily
Arm Type
Experimental
Arm Description
Participants will take capsules containing cannabidiol amounting to 200mg CBD twice daily
Arm Title
400 mg CBD twice daily
Arm Type
Experimental
Arm Description
Participants will take capsules containing cannabidiol amounting to 400mg CBD twice daily
Intervention Type
Drug
Intervention Name(s)
200mg Cannabidiol by capsules twice daily
Other Intervention Name(s)
CBD
Intervention Description
200mg twice daily via 50mg capsules
Intervention Type
Drug
Intervention Name(s)
400mg Cannabidiol by capsules twice daily
Other Intervention Name(s)
CBD
Intervention Description
400mg twice daily via 50mg capsules
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Other Intervention Name(s)
Placebo
Intervention Description
MCT oil capsules as placebo for CBD
Primary Outcome Measure Information:
Title
Change from Baseline in Disease Activity Score (DAS28/ESR)
Description
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
Title
Tolerability as assessed by participant attrition
Description
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 Outcome Measure Information:
Title
Change in Power Doppler Synovitis Score (PDUS)
Description
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
Title
Change in Grey Scale Synovial Hypertrophy Score (GSUS)
Description
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
Other Pre-specified Outcome Measures:
Title
Change in inflammatory cytokine and chemokine concentrations
Description
Inflammatory cytokines and chemokine concentrations from plasma will be evaluated using multiplex cytokine array.
Time Frame
Baseline, 12 weeks
Title
Change in white blood cell (WBC) subset percentages
Description
WBC subset percentages will be assessed via flow cytometry.
Time Frame
Baseline, 12 weeks
Title
Change in Clinical Disease Activity Index (CDAI)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Description
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.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
310-825-9956
Email
vranganath@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Veena Ranganath, MD, MS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA David Geffen School of Medicine, Division of Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolette Morris
Phone
310-825-9956
First Name & Middle Initial & Last Name & Degree
Veena K Ranganath, M.D.
First Name & Middle Initial & Last Name & Degree
Ziva Cooper, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

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