Active Rheumatoid Arthritis
Conditions
Interventions
A:Treatment of Yisaipu combined with methotrexate for 52 weeks
B:Treatment of Yisaipu combined with methotrexate for the first 24 weeks and followed by methotrexate monotherapy
C:Methotrexate monotherapy for 52 weeks
Sponsors
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with rheumatoid arthritis for more than 6 months according to the revised 1987 American College of Rheumatology (ACR) criteria; 2. During the screening and baseline periods, the swollen joints counts (SJC) should be >=6 (of total 66 joints), while the tender joints count (TJC) should be >=8 (of total 68 joints). Laboratory test ESR >=28mm/h, or CRP >= 20mg/l; Meanwhile, at least one bone erosion lesion was found on both hands/wrist X-ray; 3. Subjects were aged from 18 to 60 years old (inclusive); 4. Subjects were not treated with any marketed or unmarketed biologic agent for rheumatoid arthritis prior to screening (focusing on Enasipril, Infliximab, Adamab, Rituximab [CD20], Tocilizumab [IL-6 receptor], Abatacept [CTLA4-Ig], Anakinra [IL-1 antagonist]); 5. DMARDs medications other than MTX were discontinued 4 weeks before the trial; Subjects were allowed to take orally corticosteroids (prednisone <=10 mg/d or its equivalent) and NSAIDs (up to the maximum recommended dose), but their dose should be stable for at least 4 weeks before the baseline period; 6. Women of childbearing age agreed to use effective contraceptive measures during the trial period; 7. Urine pregnancy tests should be negative for women of reproductive age at screening; 8. Subjects would sign the informed consent voluntarily and comply with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects who had undergone major surgery (including joint surgery) within 8 weeks before screening, or who planned to undergo major surgery within 6 months after enrollment; 2. Subjects with rheumatoid autoimmune diseases other than rheumatoid arthritis including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma and polymyositis. However, subjects with Sjogren's syndrome were allowed to participate in this trial. If ANA is positive, the possibility of SLE should be excluded in combination with clinical conditions and negative anti-DNA antibody test. 3. Subjects with rheumatoid arthritis had stage IV of wrist X-ray; 4. Subjects who had or were suffering from inflammatory arthritis other than rheumatoid arthritis (such as gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy and lyme disease); 5. Subjects who had received any of the study drugs within 4 weeks (or 5 half-lives, select the longest time of two) prior to screening; 6. Subjects who had undergone any cell elimination therapy, including study drugs (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CDL9); 7. Subjects who had received intravenous gamma-globulin, plasma exchange or Prosorba column therapy within 6 months prior to baseline; 8. Subjects who received intra-articular or other corticosteroid injections within 4 weeks prior to baseline; 9. Subjects who had received any vaccine within 4 weeks before the baseline; 10. Subjects who received any alkylating agent such as cyclophosphamide, phenylbutazidine or total lymphatic irradiation therapy within 4 weeks before baseline; 11. Subjects with severe and uncontrolled cardiovascular disease, nervous system disease, pulmonary disease (including obstructive pulmonary disease and interstitial pulmonary disease), renal disease, liver disease, endocrine disease (including uncontrolled diabetes) and gastrointestinal disease; 12. Subjects with an uncontrolled disease status, such as asthma, psoriasis, inflammatory bowel disease, who usually need to take orally or inject corticosteroids to treat recurrence; 13. Subjects who are currently known to have a history of active or recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis and atypical mycobacteria disease, chest X-ray showed granulomatous disease, hepatitis B and hepatitis C, HIV infection, herpes zoster, but does not include onychomycosis), or who requiring hospitalization and intravenous antibiotic therapy within 4 weeks before screening, or who requiring oral antibiotic therapy within 2 weeks before screening; 14. Subjects with a history of malignancy, including solid tumors and hematologic malignancies (except for skin basal cell carcinoma that has been removed or cured); 15. Pregnant or lactating women (breastfeeding); 16. Subjects with neuropathy and other painful diseases that may interfere with pain assessment; 17. Serum creatinine value is greater than 1.5mg/dl; 18. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the normal upper limit (If the ALT or AST measured at the first time is greater than 2 times the upper limit of normal, the sample should be taken again during the screening period), or with total bilirubin greater than the normal upper limit (If total bilirubin was measured above the upper limit of normal value for the first time, it should be measured again during th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved Sharp scores of the X-rays in affected joints; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects reaching ACR20, ACR50 and ACR70;The changes in ACR core parameters relative to baseline;The changes in HAQ scores from baseline to 52 weeks;The duration of ACR20, ACR50 and ACR70 was reached in each treatment group;The proportion of subjects reached low disease activity at each visit;The duration of low disease activity was reached at each visit;Proportion of subjects reached remission at each visit;The duration of remission was reached at each visit;MRI changes (joint space narrowing and bone erosion); | — |
Countries
China
Contacts
Public ContactYan Zhao
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Outcome results
None listed