Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Sponsor

Chinese Academy of Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01619176

Collaborator

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine (Other)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.

The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: methotrexate Drug: non-steroidal anti-inflammatory drug (NSAID) Drug: leflunomide Drug: methotrexate Drug: non-steroidal anti-inflammatory drug (NSAID) Drug: leflunomide Procedure: Acupuncture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupuncture Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)	Drug: methotrexate methotrexate: 7.5mg/week to 15mg/week for 3 months Drug: non-steroidal anti-inflammatory drug (NSAID) NSAID: 100mg twice a day for 3 months Drug: leflunomide leflunomide: 20mg/day for 3 months Procedure: Acupuncture 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.
Active Comparator: Control Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)	Drug: methotrexate methotrexate: 7.5mg/week to 15mg/week for 3 months Drug: non-steroidal anti-inflammatory drug (NSAID) NSAID: 100mg twice a day for 3 months Drug: leflunomide leflunomide: 20mg/day for 3 months

Arm

Intervention/Treatment

Experimental: Acupuncture

Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)

Drug: methotrexate

methotrexate: 7.5mg/week to 15mg/week for 3 months

Drug: non-steroidal anti-inflammatory drug (NSAID)

NSAID: 100mg twice a day for 3 months

Drug: leflunomide

leflunomide: 20mg/day for 3 months

Procedure: Acupuncture

30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.

Active Comparator: Control

Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)

Drug: methotrexate

methotrexate: 7.5mg/week to 15mg/week for 3 months

Drug: non-steroidal anti-inflammatory drug (NSAID)

NSAID: 100mg twice a day for 3 months

Drug: leflunomide

leflunomide: 20mg/day for 3 months

Outcome Measures

Primary Outcome Measures

Change in ACR20-50-70 [3 weeks and 3 months]
ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire the number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria

Secondary Outcome Measures

Change in SDAI [3 weeks and 3 months]
simplified disease activity index SDAI, is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity [visual analogue scale (VAS) 0-10 cm] and level of C-reactive protein (mg/dl, normal <1 mg/dl) SDAI≦3.3 is the threshold to consider remission

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The patient should be diagnosed as the first or second stage of rheumatoid Arthritis (RA) and checked with X ray for additional diagnose.
diagnosed for RA according to ACR(1987)
the patient should be in the active stage of the disease, defined as：

swollen joints >3
tender joints > 5
any one of the following： (c1.) morning stiffness lasting more than 45 minutes (c2.) Erythrocyte Sedimentation Rate (ESR) >= 28mm/h (c3.) C-reactive protein (CRP)>= 12mg/L

Should not be resistant to MTX nor leflunomide
Blood test should satisfy:

Hemoglobin (Hb)>=85g/L
White cell >=3.5 10+9/L
Platelets >= 100 10+9/L
Liver function: serum alanine aminotransaminase (ALT), aspartate transaminase (AST) and total bilirubin (TBil) should be less than 1.5 times the upper limit of normal (ULN)
Kidney function: Serum creatinine (Cr) level should be less than ULN.
Pregnancy test should be negative

should be positive for anti-cyclic citrullinated protein antibodies (anti-CCP).
should agree to sign the informed consent

Exclusion Criteria:

Serious diseases affecting liver, kidney, heart and lung, or diseases related to hematologic，endocrine and nervous systems. .
Be treated by MTX or Leflunomide in the last 3 months.
Be treated with cortical hormone （could be intramuscular injection, intravenous injection or injection to articular cavity） in the last 4 weeks.
Be treated with biological agents, such as antagonist of TNF-alpha,IL-6, and CD20 mono antibody in the last 3 months.
Be treated by chronic medicine, such as immunosuppressive agent, Penicillamine, chloroquine and gold based Disease-modifying antirheumatic drugs (DMARDs) in the last 3 months.
Pregnant and breast-feeding woman
Having history of serious drug allergy
In the acute or chronic phase of infection (such as lung diseases)
Easy bleeding patients or patients with local skin infection (only for acupuncture)
The patients cannot accept acupuncture (only for acupuncture)
Be treated with acupuncture in the past 3 months（only for acupuncture）.
No pregnant and breast-feeding woman.
No history of serious drug allergy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai GuangHua Hospital of integrated traditional and western medicine	Shanghai	Shanghai	China	200052

Sponsors and Collaborators

Chinese Academy of Sciences
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Investigators

Study Chair: Christine Nardini, PhD, Key laboratory of Computational Biology, Chines Academy of Sciences - Max Planck Institute - Partner Institute for Computational Biology (CAS MPG PICB)