Status:
UNKNOWN
Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients
Lead Sponsor:
Zhang, Xiao, M.D.
Collaborating Sponsors:
Central South University
Tianjin Medical University General Hospital
Conditions:
Rheumatoid Arthritis（RA）
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A prospective, multi-centric, cohort study to observe the efficacy difference between intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever rheumatoid arthritis(RA) 28...
Detailed Description
Primary objective is compare the difference of clinical remission rate between classic conventional disease-modifying antirheumatic drugs(DMARDs) and Infliximab with methotrexate(MTX) treatment in sev...
Eligibility Criteria
Inclusion
- Able and willing to provide written informed consent and to comply with the study protocol
- Age is from 18 to 70 years old
- To accord with the diagnostic criteria of ACR/EULAR 2010 and the course of disease is less than 2 years;
- Active RA, DAS28 score is above 5.1
- At least has one poor prognostic factor including:(1)functional limitations,(2)extra-articular manifestation,(3)positive RF or Anti-Cyclic Citrullinated Peptide(CCP) antibody ,(4)X- ray confirmed bone erosion.
Exclusion
- Received Infliximab or other biologics treatment previously;
- Abnormal liver function, the level of alanine aminotransferase(ALT) and aspartate amino transferase(AST) is higher than 3 times of upper limit of normal (ULN);
- Renal dysfunction, the level of serum creatinine is higher than 1.5 times of ULN;
- Receive live virus or bacterial vaccination currently or 4 weeks before recruitment into the study;
- Previously affected by tuberculosis or with positive tuberculin test result;
- Has history of lymphoproliferative disease such as lymphoma or suspected lymphoproliferative disease through signs and symptoms such as lymphadenectasis in posterior cervical triangle, interclavicular or supratrochlear, or splenomegaly (more than 2 cm below the ribs);
- History of multiple sclerosis or other demyelinating diseases of central nervous system;
- Be allergic to experimental drug or with serious allergic constitution;
- Malignancies excluding cured skin basal cell carcinoma or carcinoma in situ of cervix;
- Systemic active infection, HIV infection or active Hepatitis B or Hepatitis B virus carriers;
- With serious medical diseases such as cardiac insufficiency (), myocardial ischemia, serious arrhythmia, renal insufficiency, serious liver dysfunction, significant hematological system diseases, hypercortisolism, uncontrollable hypertension and diabetes mellitus;
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01915537
Start Date
August 1 2013
End Date
December 1 2017
Last Update
August 5 2013
Active Locations (3)
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1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
2
XIJING Hospital
Xi’an, Shanxi, China, 710032
3
Tianjin medical university general hospital
Tianjin, Tianjin Municipality, China, 300052