Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

This study has been completed.
Sponsor:
Collaborator:
Shanghai GuangHua Hospital of integrated traditional and western medicine
Information provided by (Responsible Party):
Christine Nardini, Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT01619176
First received: June 5, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
Rheumatoid Arthritis
Drug: methotrexate
Drug: non-steroidal anti-inflammatory drug (NSAID)
Drug: leflunomide
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • Change in ACR20-50-70 [ Time Frame: 3 weeks and 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 weeks and 3 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 15
Study Start Date: October 2012
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. swollen joints >3
    2. tender joints > 5
    3. 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:

    1. Hemoglobin (Hb)>=85g/L
    2. White cell >=3.5 10+9/L
    3. Platelets >= 100 10+9/L
    4. 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)
    5. Kidney function: Serum creatinine (Cr) level should be less than ULN.
    6. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619176

Locations
China, Shanghai
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 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)
  More Information

No publications provided

Responsible Party: Christine Nardini, Principal Investigator, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT01619176     History of Changes
Other Study ID Numbers: acumicro
Study First Received: June 5, 2012
Last Updated: December 12, 2013
Health Authority: China: National Science Foundation of China (NSFC)

Keywords provided by Chinese Academy of Sciences:
Rheumatoid Arthritis
blood
gut intestinal microbiome

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Leflunomide
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014