Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients

• 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

• Name: Xiao Zhang, Ph.D
• 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: Infliximab group

Drug: Classic DMARDs treatment 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]

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]

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]

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]

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