What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis (RA) with anti-inflammatory and immunomodulatory effects include methotrexate, biologics (e.g., TNF inhibitors), and corticosteroids. Methotrexate can cause side effects such as liver toxicity, bone marrow suppression, and gastrointestinal issues. Biologics may increase the risk of infections, injection site reactions, and in some cases, may lead to the development of antibodies against the drug. Corticosteroids are associated with side effects like weight gain, osteoporosis, hypertension, and increased susceptibility to infections. Cannabidiol (CBD), while still under study, has shown potential side effects including diarrhea, fatigue, and changes in appetite.

What prior FDA approvals exist?

The FDA has approved several treatments for rheumatoid arthritis that possess anti-inflammatory and immunomodulatory effects. These include disease-modifying antirheumatic drugs (DMARDs) such as methotrexate, biologic agents like tumor necrosis factor (TNF) inhibitors (e.g., infliximab, adalimumab, etanercept), and interleukin-6 (IL-6) inhibitors such as tocilizumab. These treatments aim to reduce inflammation and modulate the immune response, similar to the proposed effects of cannabidiol (CBD). While CBD is being studied for its potential benefits in RA, it is not yet FDA-approved for this indication.

What other types of research exist?

Promising novel alternatives to Cannabidiol (CBD) for Rheumatoid Arthritis patients in 2024 include Janus Kinase (JAK) inhibitors such as upadacitinib and tofacitinib, and Interleukin-17 (IL-17) inhibitors like secukinumab and ixekizumab. These agents have shown efficacy in reducing inflammation and modulating the immune response in RA patients, especially those who have not responded adequately to TNF inhibitors.

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CBD for Rheumatoid Arthritis

Phase 1

Waitlist Available

Led By Ziva Cooper, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18

Be older than 18 years old

Must not have

Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

>10mg of prednisone daily use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial tests if CBD can help RA patients who are already on stable therapy by reducing their pain and inflammation. Patients will take either CBD or a non-active substance for a few months to see if it makes a difference.

Who is the study for?

Adults with active Rheumatoid Arthritis (RA) who have been on stable RA therapy for at least 12 weeks can join this trial. They must not have used cannabis recently, be free of chronic infections or substance use disorders, and agree to effective contraception if they are capable of childbearing.

What is being tested?

The study is testing the effectiveness and safety of two different doses of Cannabidiol (CBD), compared to a placebo, in patients with RA. Participants will continue their regular RA treatments while adding either CBD or placebo capsules twice daily.

What are the potential side effects?

Potential side effects from CBD may include tiredness, changes in appetite, gastrointestinal discomfort, and mood alterations. Since it's being tested as an add-on therapy, interactions with existing medications could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver function is moderately or severely impaired.

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I take more than 10mg of prednisone daily.

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I use medications daily that help me relax or sleep.

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I am not pregnant, planning to become pregnant, or breastfeeding.

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I am sexually active and not using birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Electron Spin Resonance Spectroscopy

Tolerability as assessed by participant attrition

Secondary study objectives

Change in Grey Scale Synovial Hypertrophy Score (GSUS)

Change in Power Doppler Synovitis Score (PDUS)

Other study objectives

Change in Clinical Disease Activity Index (CDAI)

Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)

Change in inflammatory cytokine and chemokine concentrations

+1 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 400 mg CBD twice dailyExperimental Treatment1 Intervention

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

Group II: 200mg CBD twice dailyExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

FDA approved

Cannabidiol

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Rheumatoid Arthritis (RA) treatments primarily focus on reducing inflammation and modulating the immune system to prevent joint damage. Common treatments include Disease-Modifying Antirheumatic Drugs (DMARDs) like methotrexate, which reduce immune cell activity, and biologic agents such as TNF inhibitors that block inflammatory cytokines. Janus kinase (JAK) inhibitors disrupt key immune signaling pathways. Cannabidiol (CBD) is being explored for its anti-inflammatory and immunomodulatory effects, potentially offering a new approach to managing RA with fewer side effects compared to traditional therapies.

Efficacy, Tolerability, and Safety of Cannabinoid Treatments in the Rheumatic Diseases: A Systematic Review of Randomized Controlled Trials.