Clinical trial NCT01619176: Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
Official title: Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
blood
gut intestinal microbiome
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
First posted: 2012-06-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: ACR20 Response Rate at 3 Weeks
timeFrame: From baseline to 3 weeks
measure: ACR20 Response Rate at 3 Months
timeFrame: From baseline to three months
Secondary outcomes:
measure: ACR50 Response Rate at 3 Weeks
timeFrame: From baseline to 3 weeks
measure: ACR50 Response Rate at 3 Months
timeFrame: From baseline to three months
measure: ACR70 Response Rate at 3 Weeks
timeFrame: From baseline to 3 weeks
measure: ACR70 Response Rate at 3 Months
timeFrame: From baseline to three months
measure: DAS28 at Baseline
timeFrame: At baseline
measure: DAS28 at 3 Weeks
timeFrame: At 3 weeks
measure: DAS28 at 3 Months
timeFrame: At 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai GuangHua Hospital of integrated traditional and western medicine
state: Shanghai
Study officials:
affiliation: Key laboratory of Computational Biology,Chines Academy of Sciences-Max Planck Institute-CAS MPG PICB
name: Christine Nardini, PhD
role: STUDY_CHAIR
affiliation: Consiglio Nazionale delle Ricerche Istituto per le Applicazioni del Calcolo "Mauro Picone"
name: Christine Nardini, PhD
role: STUDY_CHAIR
affiliation: Shanghai Institute of Biochemistry and Cell Biology, CAS, Shanghai, PRC
name: Yuanhua Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Guanghua Hospital, Shanghai, PRC
name: Yongying Liang
role: PRINCIPAL_INVESTIGATOR
affiliation: Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China
name: Xiaoyuan Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China
name: Jennifer E. Dent
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, University of California, San Francisco, USA
name: Ting Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Guanghua Hospital, Shanghai, PRC
name: Ding Qin
role: PRINCIPAL_INVESTIGATOR
affiliation: Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China
name: Youtao Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Guanghua Hospital, Shanghai, PRC
name: Dongyi He
role: STUDY_DIRECTOR
References:
citation: Liu, Y. et al. (2023). Wound Healing from Bench to Bedside: A PPPM Bridge Between Physical Therapies and Chronic Inflammation. In: Podbielska, H., Kapalla, M. (eds) Predictive, Preventive, and Personalised Medicine: From Bench to Bedside. Advances in Predictive, Preventive and Personalised Medicine, vol 17. Springer, Cham. https://doi.org/10.1007/978-3-031-34884-6_12