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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01915537
Date of registration: 30/07/2013
Prospective Registration: Yes
Primary sponsor: Zhang, Xiao, M.D.
Public title: Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients INNOVATION
Scientific title: A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis
Date of first enrolment: August 2013
Target sample size: 170
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01915537
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
China
Contacts
Name:     Xiao Zhang, Ph.D
Address: 
Telephone: +86 139 222 55387
Email: zhangxiao20130724@163.com
Affiliation: 
Name:     Xiao Zhang, Ph.D
Address: 
Telephone:
Email:
Affiliation:  Director
Key inclusion & exclusion 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;



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis(RA)
Intervention(s)
Drug: Classic DMARDs treatment group
Drug: Infliximab group
Primary Outcome(s)
The rate of subjects achieving DAS<2.6 [Time Frame: at week 30]
Secondary Outcome(s)
The rate of subjects achieving SDAI<3.3 [Time Frame: at week 14, 30, 54 and 102]
The SHARP score [Time Frame: at week 14, 30, 54 and 102]
MRI score [Time Frame: at week 14, 30, 54 and 102]
The level of CRP [Time Frame: at week 2, 6, 14, 22, 30, 54 and 102]
The HAQ score [Time Frame: at week 14, 30, 54 and 102]
The rate of subjects achieving DAS<2.6 [Time Frame: at week 14, 54 and 102]
The level of ESR [Time Frame: at week 2, 6, 14, 22, 30, 54 and 102]
The rate of subjects achieving ACR/EULAR remission [Time Frame: at week 14, 30, 54 and 102]
Secondary ID(s)
INNOVATION
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Xijing Hospital
Central South University
Tianjin Medical University General Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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