Phase Ib Randomized, Double-Blind, Placebo-Controlled Study of Meriva in Rheumatoid Arthritis

University of Arizona1 site in 1 country3 target enrollmentNovember 2015

ConditionsRheumatoid Arthritis

Interventionsplacebo Meriva

DrugsMeriva placebo

Overview

Phase: Phase 1
Intervention: placebo
Conditions: Rheumatoid Arthritis
Sponsor: University of Arizona
Enrollment: 3
Locations: 1
Primary Endpoint: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out whether turmeric dietary supplements that are available over the counter for general use in the United States are safe and useful when taken specifically for the treatment of rheumatoid arthritis (RA) and how the active principles in turmeric are broken down and metabolized by the body in individuals with RA.

Detailed Description

A placebo-controlled, double-blind, three-arm Phase Ib clinical trial assessing two doses of a commercially available curcuminoid formulation with enhanced bioavailability vs. placebo in a rheumatoid arthritis (RA) population is proposed. The primary aim of this clinical planning study is to determine the dose-dependent tolerability of an enhanced bioavailability curcuminoid formulation in an RA population, including pharmacokinetic analyses, to inform the design of a future Phase II trial assessing the anti-inflammatory efficacy of curcuminoids in the treatment of RA. Secondarily, estimates of effect size for changes in known biomarkers of inflammation in RA will be determined.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

September 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Arizona

Responsible Party

Principal Investigator

Janet L. Funk

Associate Professor

University of Arizona

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria
•Diagnosis of RA (ACR 2010 criteria)
•Age \> 18 years old
•Active disease at screening visit as defined by:
•Disease Activity Score \[DAS\]-28 (4)-erythrocyte sedimentation rate (ESR) \> 3.2, and
•C reactive protein (CRP) \> 1.0 mg/dL or ESR \>
•Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

•Current treatment with any biologic agent (e.g. tumor necrosis factor (TNF) inhibitors: etanercept , infliximab, adalimumab; interleukin 1(IL-1) inhibitors: anakinra ; lymphocyte directed: abatacept, rituximab; and Janus kinase (JAK) inhibitors: tofacitinib).
•Past biologic use allowed if ended \> 3 months prior to randomization (\> 12 months for Rituximab)
•History of non-response to biologics.
•Disease-modifying anti-inflammatory agents (DMARDs), including methotrexate, hydroxychloroquine, sulfasalazine, and minocycline, will be allowed if stable for 1 month prior to randomization and unchanged throughout the study.
•Leflunomide, gold compounds, azathioprine, or cyclosporine will be exclusionary if used within the month prior to randomization.
•Oral Corticosteroid use \> 10 mg/d prednisolone or equivalent or parenteral corticosteroids of any dose will be exclusionary (1 month prior to randomization until final assessment visit).
•Oral corticosteroids in low doses (\< 10 mg/d prednisone or equivalent) will be allowed if stable for 1 month prior to randomization and unchanged throughout the study).
•Topical, inhaled, or intranasal steroids are not exclusionary
•Past parenteral or oral (\> 10 mg/d prednisolone equivalent) corticosteroids allowed if not used within one month prior to randomization
•Non-steroidal anti-inflammatory drugs (NSAID) are exclusionary if used continuously or \> 3 doses in 7 days.