Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From "Real World"

• Register: ClinicalTrials.gov
• Last refreshed on: 29 August 2016
• Main ID: NCT02878161
• Date of registration: 12/07/2016
• Prospective Registration: No
• Primary sponsor: Fen Li
• Public title: Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From "Real World"
• Scientific title: Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From "Real World" and Investigating Its Mechanism Through Signal Pathway
• Date of first enrolment: January 2016
• Target sample size: 240
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT02878161
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 4

Contacts

• Name: Fen Li, doctor
• Affiliation: Central South University

Key inclusion & exclusion criteria

Inclusion Criteria:

- signed the consents voluntarily

- age between 18-75 years old

- patients were meet the American College of Rheumatology(ACR)

- European League Against Rheumatism(EULAR) 2009 diagnostic criteria (total scores
beyond 6)

- for severe RA patients DAS28-CRP=5.1

- The participants receiving Infliximab plus Methotrexate will be invited to enroll the
study.

- The participants receiving Etanercept plus Methotrexate will be invited to enroll the
study.

- The participants receiving Adalimumab plus Methotrexate will be invited to enroll the
study.

Exclusion Criteria:

- The patient have the disease history or the disease of cardiovascular, respiratory
system, liver, gastrointestinal tract, endocrine, hematology, neurology or
psychiatric disturbance, and investigator believe that there are some risks for
patients with these disease history or disease when use study drugs, or these disease
history or disease will disturb the interpret of data

- Patients with cancer in situ or exist the possibility of cancer malignancies

- Basically or completely loss of mobility, lack self-care ability, such as rely on a
wheelchair or bed-ridden .

- Experimental examination display any of the following:

Aspartate aminotransferase or alanine aminotransferase>1.5 times of the upper limit of the
normal value Total bilirubin>1.5 times of the upper limit of the normal value Total white
blood cells <2500 cells/L absolute neutrophil count <1200 cells/L lymphocyte count <750
cells/L platelet<100000/L

- Patients with symptomatic herpes simplex

- Latent tuberculosis signal (PPD+++ OR T-SPOT>5 )

- Positive result of the hepatitis B virus (HBV):

HBsAg + Or HBeAg + Or HBeAg + Or HBcAb + Or HBV DNA +

- hepatitis C virus(HCV)+ or HCV RNA +

- HIV infection or HIV+

- 1 months before join the group, from a clinical point of view,patients have a serious
infection caused by the virus, bacteria, fungi, or parasites

- Pregnancy ? location ?prepare for conceive in one years or there is risk to
impregnate their partners

- Patients received any biological therapies for 6 months, or participated any other
clinical trials of new drugs

- A history of drug allergy

- A history of heavy drink

- vaccinate the live vaccine recently



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: infliximab

Biological: adalimumab

Drug: NSAIDs (permitted,not necessary)

Biological: etanercept

Drug: leflunomide (permitted, not necessary)

Drug: Glucocorticoids (permitted,not necessary)

Drug: methotrexate(necessary)

Primary Outcome(s)

EULAR (European League Against Rheumatism) response will be assessed among patients of 3 groups [Time Frame: Baseline, Weeks 14]

Secondary Outcome(s)

The SNP of gene about interest proteins with different EULAR response will be assessed among patients of 3 groups. [Time Frame: Weeks 14]

The SNP (Single nucleotide polymorphism) of gene about TNF with different EULAR response will be assessed among patients of 3 groups. [Time Frame: Weeks 14]

The changes of TNF level with different EULAR response will be assessed among patients of 3 groups. [Time Frame: Baseline, Weeks 14]

The changes of Interest proteins with different EULAR response will be assessed among patients of 3 group. [Time Frame: Baseline, Weeks 14]

Secondary ID(s)

XYEYY-GZ81571599-20160118-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors