Last updated: November 8, 2023
Sponsor: Chinese Academy of Sciences
Overall Status: Completed
Phase
N/A
Condition
Joint Injuries
Dermatomyositis (Connective Tissue Disease)
Rheumatoid Arthritis
Treatment
non-steroidal anti-inflammatory drug (NSAID)
Acupuncture
leflunomide
Clinical Study ID
NCT01619176
acumicro
Ages 18-65 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 ofnormal (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
Exclusion Criteria:
- Serious diseases affecting liver, kidney, heart and lung, or diseases related tohematologic,endocrine and nervous systems. .
- Be treated by MTX or Leflunomide in the last 3 months.
- Be treated with cortical hormone (could be intramuscular injection, intravenousinjection 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 monoantibody 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.
Study Design
Total Participants: 10
Treatment Group(s): 4
Primary Treatment: non-steroidal anti-inflammatory drug (NSAID)
Phase:
Study Start date:
October 01, 2012
Estimated Completion Date:
December 31, 2014
Connect with a study center
Shanghai GuangHua Hospital of integrated traditional and western medicine
Shanghai, Shanghai 200052
ChinaSite Not Available

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