Clinical trial NCT00752154: Curcumin in Rheumatoid Arthritis
Official title: Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Subjects
active
Rheumatoid
Arthritis
revised
American
College
Rheumatology
Criteria
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2008-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: American College of Rheumatology 20%
timeFrame: 4 month period
Secondary outcomes:
measure: Inflammatory cell signaling markers
timeFrame: 4 month
measure: Safety of curcumin
timeFrame: 8 month
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203
state: California
city: Los Angeles
country: United States
facility: UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Dinesh Khanna, M.D.
role: PRINCIPAL_INVESTIGATOR
References: