Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
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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 |
- 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
- 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 |
| Estimated Primary Completion Date: | October 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 |
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| Contact: Christine Nardini, PhD | christine@picb.ac.cn |
| China, Shanghai | |
| Shanghai GuangHua Hospital of integrated traditional and western medicine | Recruiting |
| Shanghai, Shanghai, China, 200052 | |
| Principal Investigator: Yongying Liang, MD | |
| Principal Investigator: Dongyi He, MD | |
| Sub-Investigator: Ting Jiang, MD | |
| Sub-Investigator: Qin Ding, MD | |
| 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: | October 24, 2012 |
| 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 Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Methotrexate Leflunomide Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013