Curcumin in Rheumatoid Arthritis

Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study

Curcuma longa or turmeric is a tropical plant native to south and southeast tropical Asia. Perhaps the most active component in turmeric is curcumin which may make up 2-5% of the total spice in turmeric. The study drug being tested in this study is curcumin.

This study is called a cross-over study because all subjects will receive the study drug for a certain amount of time and then switch to placebo (an inactive substance) for a certain time or vice versa. The subject's participation may last up to 8 months.

The subject will be randomized (by chance; like flipping a coin) to receive either the study drug, curcumin, or placebo for 4 months. After 4 months, if the subject was taking curcumin they will stop taking it and begin to take placebo and if the subject was taking placebo they will stop taking it and begin taking curcumin for the remaining 4 months. By completion of the study, all 40 subjects will have taken curcumin and placebo for 4 months each.

Curcumin/placebo will be provided in capsule form and the subject will take it by mouth. The dose dose will be increased every week for up to a total of 4 grams per day.

Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Curcumin (Longvida™)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Amber Bechtel, BS; Phone Number: 310-825-0425; Email: abechtel@mednet.ucla.edu
• Study Contact Backup: Name: Emma Hasan, Study Coordinator; Phone Number: 310-206-5732; Email: hasan@mednet.ucla.edu

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90042
      • Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203
    • Los Angeles, California, United States, 90095
      • UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years; read and understand English
2. Stable dose of non-steroidal anti-inflammatory agents (NSAID) for ≥ 2 weeks.

3. Oral prednisone or equivalent ≤ 10 mg daily and stable dose for ≥ 2 weeks(and must be kept stable throughout the duration of the protocol).

   • ESR > 20 mm/hr, or CRP > 0.8 mg/dl
4. May be using any of the following DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or leflunomide. If using any of these DMARDs must be using them for ≥ 12 weeks and stable dose for ≥ 4 weeks. If using other DMARD, or DMARD combinations, these additional or other DMARDs must be stopped for ≥ 4 weeks before baseline visit. May also participate if patient not on DMARD,
5. Subjects must be diagnosed with rheumatoid arthritis based on the revised American College of Rheumatology criteria:Presence of > swollen and > 6 tender joint count (28 joint count), and either ESR > 20 mm/hr or CRP > 0.8 mg/dl

Exclusion Criteria:

1. Acute medical conditions deemed as inappropriate by the investigators (acute heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
2. AST/ALT > 1.5 upper limit of normal (ULN)
3. Serum creatinine > 1.6 mg/dl
4. Hemoglobin/Hematocrit < 10.0 gram/dl/ 30.0
5. Platelet count < 100,000
6. Current use of warfarin (as there is a drug interaction between curcumin and warfarin).
7. Currently on biologic therapy (must have stopped etanercept for ≥ 4 weeks or adalimumab or infliximab for ≥ 8 weeks at time of Time 1 visit),
8. Women who are pregnant,
9. Subjects who are taking digoxin, warfarin and/or heparin,
10. Subjects with a history of antiphospholipid syndrome and other thrombophilic states,
11. Subjects who have an INR >= 1.5 at baseline,
12. Subjects with acute episode(s) of cholecystitis within the last 6 months,
13. Subjects with active peptic ulcer disease within the last 6 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
American College of Rheumatology 20%	4 month period

Secondary Outcome Measures

Outcome Measure	Time Frame
Inflammatory cell signaling markers	4 month
Safety of curcumin	8 month

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Dinesh Khanna, M.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 12, 2008
• First Posted (Estimated): September 15, 2008

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Arthritis; Rheumatoid; Subjects; Criteria; Rheumatology; active; College; revised; American
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 07-12-051