NCT04911127CompletedPhase 1
Therapeutic Response of Cannabidiol in Rheumatoid Arthritis
Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 7 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 14 May 2021
- Start date
- 5 Oct 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04911127
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 67
- From 5 Oct 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to cannabis \<= 28 days prior to baseline
- Daily use of central nervous system (CNS) depressant medications (e.g. sedatives, hypnotics \[zolpidem, temazepam, alprazolam, lorazepam, diphenhydramine etc.\])
Other illness
- Current diagnosed substance use disorders (including Alcohol Use Disorder)
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Chronic infections
- History of an allergic reaction or adverse reaction to cannabis is exclusionary.
Other
- \>10mg of prednisone daily use
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA David Geffen School of Medicine, Division of Rheumatology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.