Curcuma Longa L in Rheumatoid Arthritis

NCT ID: NCT02543931

Last Updated: 2016-11-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-09-30

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.

Conditions

Rheumatoid Arthritis

Keywords

turmeric; curcumin; curcuminoids; arthritis; methotrexate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants will take 4 placebo capsules twice a day for one month

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo capsules containing inert ingredients

Meriva, low dose

Participants will take 4 Meriva-250mg capsules twice a day for one month

Group Type: EXPERIMENTAL

Meriva

Intervention Type: DRUG

Meriva is an enhanced-bioavailability, curcuminoid-enriched turmeric dietary supplement that is sold over the counter in the United States and other countries.

Meriva, high dose

Participants will take 4 Meriva-500mg capsules twice a day for one month

Group Type: EXPERIMENTAL

Meriva

Intervention Type: DRUG

Meriva is an enhanced-bioavailability, curcuminoid-enriched turmeric dietary supplement that is sold over the counter in the United States and other countries.

Interventions

Meriva

Meriva is an enhanced-bioavailability, curcuminoid-enriched turmeric dietary supplement that is sold over the counter in the United States and other countries.

Intervention Type: DRUG

placebo

Placebo capsules containing inert ingredients

Intervention Type: DRUG

Other Intervention Names

turmeric, enhanced bioavailability; inactive capsule

Eligibility 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 > 20.
• 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.

o Enrollment will be allowed after a washout period of 1 week prior to randomization for use of >3 doses In 7 days).

• Herbal supplements will be exclusionary.

o Enrollment will be allowed after a washout period of 1 week prior to randomization). Patients will also be asked to minimize intake of curcuminoid-containing foods during the entire study period.

• History of positive skin test for tuberculosis (TB) without treatment.
• Systemic complications of RA (e.g. vasculitis).
• Recent surgery < 1 month prior, or scheduled surgery < 2 months after randomization
• History of malignancy, other than superficial basal or squamous cell carcinoma of the skin.
• History of, or concurrent, serious chronic infection.
• Women who are pre-menopausal (women with menses within the past 12-months) with an intact uterus must have a negative pregnancy test at screening and randomization, must be using a medically acceptable form of birth control, and may not be breast feeding.
• Worsening or uncontrolled end organ disease or intercurrent illness which, in the opinion of the investigator, may pose an added risk to the patient including, but not limited to, evidence of impaired renal function , hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or psychiatric disease.
• Acute or chronic liver disease, including Gilbert's syndrome.
• History of any atrioventricular (AV) nodal conduction defect or a P-R interval (interval between P wave QRS complex) and on ECG > 0.2 sec.
• Use of illicit drugs or high alcohol consumption or current/recent (within past 5 years) history of drug or alcohol abuse.
• Treatment within 28 days of randomization with another investigational agent,
• Have a history of allergic reactions to turmeric, Meriva, or curcuminoids, including turmeric-containing foods such as curry or mustard.
• Inability or difficulty in swallowing oral medications, or any malabsorption condition.
• Inability to provide informed consent for any reason or to complete simple questionnaires.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Janet L. Funk

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet Funk, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Arizona

Locations

The University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

R34AT007837

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1501627690

Identifier Type: -

Identifier Source: org_study_id