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

NCT02878161 | Unknown Phase 4

• 1 other identifier: XYEYY-GZ81571599-20160118-1
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; tumor necrosis factor α inhibitor; predictive; iTRAQ; signal pathway

Outcome Measures

Primary Outcomes (1)

• EULAR (European League Against Rheumatism) response will be assessed among patients of 3 groups

  EULAR (European League Against Rheumatism) response is based on changes of DAS28-CRP. The following good, moderate and no response are defined based on changes of DAS28-CRP from baseline to weeks 14: \>1.2 units are good response; 0.6-1.2 units are moderate response; ≤0.6 units are no response. The DAS28-CRP will be calculated at every visit within the clinical database. The components of the DAS28-CRP score assessment are: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement will be made at baseline and weeks 14.

  Baseline, Weeks 14

Secondary Outcomes (4)

• The changes of TNF level with different EULAR response will be assessed among patients of 3 groups.

  Baseline, Weeks 14

• The changes of Interest proteins with different EULAR response will be assessed among patients of 3 group.

  Baseline, Weeks 14

• The SNP (Single nucleotide polymorphism) of gene about TNF with different EULAR response will be assessed among patients of 3 groups.

  Weeks 14

• The SNP of gene about interest proteins with different EULAR response will be assessed among patients of 3 groups.

  Weeks 14

Study Arms (3)

A group

EXPERIMENTAL

Infliximab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.

Drug: methotrexate(necessary); Biological: infliximab; Drug: leflunomide (permitted, not necessary); Drug: NSAIDs (permitted,not necessary); Drug: Glucocorticoids (permitted,not necessary)

B group

EXPERIMENTAL

Etanercept plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.

Drug: methotrexate(necessary); Biological: etanercept; Drug: leflunomide (permitted, not necessary); Drug: NSAIDs (permitted,not necessary); Drug: Glucocorticoids (permitted,not necessary)

C group

EXPERIMENTAL

Adalimumab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.

Drug: methotrexate(necessary); Biological: adalimumab; Drug: leflunomide (permitted, not necessary); Drug: NSAIDs (permitted,not necessary); Drug: Glucocorticoids (permitted,not necessary)

Interventions

methotrexate(necessary) DRUG

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

Also known as: MTX

A group; B group; C group

infliximab BIOLOGICAL

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

Also known as: IFX

A group

etanercept BIOLOGICAL

Etanercept :hypodermic injection,25mg/twice a week

Also known as: ETN

B group

adalimumab BIOLOGICAL

Adalimumab:hypodermic injection,40mg/twice a week

Also known as: ADA

C group

leflunomide (permitted, not necessary) DRUG

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

Also known as: LEF

A group; B group; C group

NSAIDs (permitted,not necessary) DRUG

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

Also known as: non steroidal anti inflammatory drugs

A group; B group; C group

Glucocorticoids (permitted,not necessary) DRUG

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.

Also known as: prednisone,methylprednisolone,etc.

A group; B group; C group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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+
• 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

Sponsors & Collaborators

• Fen Li: lead

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab; Etanercept; Adalimumab; Leflunomide; Licensure; Anti-Inflammatory Agents, Non-Steroidal; Glucocorticoids; Prednisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Credentialing; Social Control, Formal; Health Care Economics and Organizations; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Fen Li, doctor

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: August 25, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 25, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share