Curcuma Longa L in Rheumatoid Arthritis

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 > 20.

• Ability to understand and the willingness to sign a written informed consentdocument

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 forRituximab)

• History of non-response to biologics.

• Disease-modifying anti-inflammatory agents (DMARDs), including methotrexate,hydroxychloroquine, sulfasalazine, and minocycline, will be allowed if stable for 1month prior to randomization and unchanged throughout the study.

• Leflunomide, gold compounds, azathioprine, or cyclosporine will be exclusionary ifused within the month prior to randomization.

• Oral Corticosteroid use > 10 mg/d prednisolone or equivalent or parenteralcorticosteroids of any dose will be exclusionary (1 month prior to randomization untilfinal assessment visit).

• Oral corticosteroids in low doses (< 10 mg/d prednisone or equivalent) will beallowed if stable for 1 month prior to randomization and unchanged throughout thestudy).

• Topical, inhaled, or intranasal steroids are not exclusionary

• Past parenteral or oral (> 10 mg/d prednisolone equivalent) corticosteroidsallowed 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 randomizationfor 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 duringthe 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 theskin.

• History of, or concurrent, serious chronic infection.

• Women who are pre-menopausal (women with menses within the past 12-months) with anintact uterus must have a negative pregnancy test at screening and randomization, mustbe 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 theopinion of the investigator, may pose an added risk to the patient including, but notlimited 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 5years) 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, includingturmeric-containing foods such as curry or mustard.

• Inability or difficulty in swallowing oral medications, or any malabsorptioncondition.

• Inability to provide informed consent for any reason or to complete simplequestionnaires.