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

NCT02878161 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-08-25

No results posted yet for this study

Summary

Rheumatoid arthritis (RA) is a chronic and disabling disease. tumor necrosis factor-a(TNF-a) inhibitors have demonstrated an outstanding performance in relieving joint inflammation and retarding bone erosion involved in RA. However, there is still about one-thirds of RA patients had a poor response to TNF α inhibitors. The Investigators hope to discover prediction protein with a domestic genetic background and finally establish prediction system with Chinese characteristics.

Conditions

Interventions

DRUG

methotrexate(necessary)

Methotrexate will be received orally with dosage of 10mg/ week for every patient and MTX dose must be stable for at least 4 weeks.

BIOLOGICAL

infliximab

infliximab :intravenous injection 200mg,every times,0,2,6,14week ,4 times)

BIOLOGICAL

etanercept

Etanercept :hypodermic injection,25mg/twice a week

BIOLOGICAL

adalimumab

Adalimumab:hypodermic injection,40mg/twice a week

DRUG

leflunomide (permitted, not necessary)

LEF will be permitted if patient had received for 1 month before enrollment and will not be changed for 14 weeks.

DRUG

NSAIDs (permitted,not necessary)

NSAIDs will be allowed if patient had received for 1 month before enrollment and will not be changed for 14 weeks.

DRUG

Glucocorticoids (permitted,not necessary)

Glucocorticoids (prednisone less than 10mg/day, or equal dosage of other similar drugs) will be permitted if the patient had received for 1 month before enrollment and the dosage will not be changed during the period.

Sponsors & Collaborators

  • Fen Li

    lead OTHER

Principal Investigators

  • Fen Li, doctor · Second Xiangya Hospital of Central South University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02878161 on ClinicalTrials.gov