Curcuma Longa L in Rheumatoid Arthritis

NCT02543931 | Terminated Phase 1 DMC

• 2 other identifiers: 1501627690R34AT007837
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

turmeric; curcumin; curcuminoids; arthritis; methotrexate

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  1 week and 4 weeks

• Area under curve (AUC)

  Following first dose.

  0-24 h

• Cmax

  Following first dose.

  0-24h

• Tmax

  Following first dose.

  0-24h

• T1/2

  Following first dose.

  0-24h

• Cmax

  Plasma concentration after multiple daily dosings

  1 week and 4 week

Secondary Outcomes (1)

• Changes in biomarkers of inflammation

  1 and 4 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Meriva, low dose

EXPERIMENTAL

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

Drug: Meriva

Meriva, high dose

EXPERIMENTAL

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

Drug: Meriva

Interventions

Meriva DRUG

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

Also known as: turmeric, enhanced bioavailability

Meriva, high dose; Meriva, low dose

placebo DRUG

Placebo capsules containing inert ingredients

Also known as: inactive capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).
• Past parenteral or oral (\> 10 mg/d prednisolone equivalent) corticosteroids allowed if not used within one month prior to randomization
• o Enrollment will be allowed after a washout period of 1 week prior to randomization for use of \>3 doses In 7 days).
• 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.

Sponsors & Collaborators

• University of Arizona: lead
• Vanderbilt University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Janet Funk, MD

  The University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: September 7, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

US (1)