Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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 joints disease activity score>5.1(DAS28>5.1) patients with poor prognostic factors.Primary objective is compare the difference of clinical remission rate between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 30.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhang, Xiao, M.D.
• Collaborators: Central South University; Tianjin Medical University General Hospital; Xijing Hospital
• Treatments: Antirheumatic Agents; Infliximab

Criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol

2. Age is from 18 to 70 years old

3. To accord with the diagnostic criteria of ACR/EULAR 2010 and the course of disease is less than 2 years;

4. Active RA, DAS28 score is above 5.1

5. 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 Criteria:

1. Received Infliximab or other biologics treatment previously;

2. 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);

3. Renal dysfunction, the level of serum creatinine is higher than 1.5 times of ULN;

4. Receive live virus or bacterial vaccination currently or 4 weeks before recruitment into the study;

5. Previously affected by tuberculosis or with positive tuberculin test result;

6. 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);

7. History of multiple sclerosis or other demyelinating diseases of central nervous system;

8. Be allergic to experimental drug or with serious allergic constitution;

9. Malignancies excluding cured skin basal cell carcinoma or carcinoma in situ of cervix;

10. Systemic active infection, HIV infection or active Hepatitis B or Hepatitis B virus carriers;

11. 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;