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NCT Number: NCT01619176

Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai GuangHua Hospital of integrated traditional and western medicine

Shanghai, Shanghai Municipality, 200052, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methotrexate

Drug

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

non-steroidal anti-inflammatory drug (NSAID)

Drug

NSAID: 100mg twice a day for 3 months

leflunomide

Drug

leflunomide: 20mg/day for 3 months

Acupuncture

Procedure

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.

Primary outcomes

  1. ACR20 Response Rate at 3 Weeks

    Time frame: From baseline to 3 weeks

    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 (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

  2. ACR20 Response Rate at 3 Months

    Time frame: From baseline to three 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 (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

Secondary outcomes

  1. ACR50 Response Rate at 3 Weeks

    Time frame: From baseline to 3 weeks

    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 (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

  2. ACR50 Response Rate at 3 Months

    Time frame: From baseline to three 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 (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

  3. ACR70 Response Rate at 3 Weeks

    Time frame: From baseline to 3 weeks

    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 (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

  4. ACR70 Response Rate at 3 Months

    Time frame: From baseline to three 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 (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)

  5. DAS28 at Baseline

    Time frame: At baseline

    The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.

    The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 2.6-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease

  6. DAS28 at 3 Weeks

    Time frame: At 3 weeks

    The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.

    The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease

  7. DAS28 at 3 Months

    Time frame: At 3 months

    The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.

    The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Registry information

Official study title

Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2012
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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