Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"
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ClinicalTrials.gov Identifier: NCT02878161 |
Recruitment Status : Unknown
Verified July 2016 by Fen Li, Central South University.
Recruitment status was: Enrolling by invitation
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
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Condition or disease | Intervention/treatment | Phase |
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Rheumatoid Arthritis | Drug: methotrexate(necessary) Biological: infliximab Biological: etanercept Biological: adalimumab Drug: leflunomide (permitted, not necessary) Drug: NSAIDs (permitted,not necessary) Drug: Glucocorticoids (permitted,not necessary) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Screening Protein Predictive of Response to Tumor Necrosis Factor-α Inhibitors Treatment in Chinese Rheumatoid Arthritis From "Real World" and Investigating Its Mechanism Through Signal Pathway |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
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Experimental: A group
Infliximab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.
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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.
Other Name: MTX Biological: infliximab infliximab :intravenous injection 200mg,every times,0,2,6,14week ,4 times)
Other Name: IFX 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.
Other Name: LEF 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.
Other Name: non steroidal anti inflammatory drugs 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.
Other Name: prednisone,methylprednisolone,etc. |
Experimental: B group
Etanercept plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.
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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.
Other Name: MTX Biological: etanercept Etanercept :hypodermic injection,25mg/twice a week
Other Name: ETN 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.
Other Name: LEF 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.
Other Name: non steroidal anti inflammatory drugs 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.
Other Name: prednisone,methylprednisolone,etc. |
Experimental: C group
Adalimumab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.
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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.
Other Name: MTX Biological: adalimumab Adalimumab:hypodermic injection,40mg/twice a week
Other Name: ADA 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.
Other Name: LEF 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.
Other Name: non steroidal anti inflammatory drugs 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.
Other Name: prednisone,methylprednisolone,etc. |
- EULAR (European League Against Rheumatism) response will be assessed among patients of 3 groups [ Time Frame: Baseline, Weeks 14 ]
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.
- The changes of TNF level with different EULAR response will be assessed among patients of 3 groups. [ Time Frame: Baseline, Weeks 14 ]
The TNF level assessment is a direct measurement using ELISA by testing patients' serum. This measurement will be made at baseline and weeks 14.
The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.
- The changes of Interest proteins with different EULAR response will be assessed among patients of 3 group. [ Time Frame: Baseline, Weeks 14 ]
Interest proteins will be screened by iTRAQ (isobaric tags for relative and absolute quantitation). This measurement will be made at baseline and weeks 14 by comparing part of patients with good response or no response.
Interest proteins being screened will be verified by Western Blot among all patients of 3 groups.
The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.
- 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 ]
SNP of TNF gene will be tested by PCR-RFLP (Polymerase Chain Reaction -Restriction Fragment Length Polymorphism). This measurement will be made at weeks 14 among all 3 groups' patients.
The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.
- The SNP of gene about interest proteins with different EULAR response will be assessed among patients of 3 groups. [ Time Frame: Weeks 14 ]
SNP of gene about interest proteins will tested by PCR-HRM(Polymerase Chain Reaction-high resolution melting). This measurement will be made at weeks 14 among all 3 groups' patients.
Interest proteins are screened and verified on above of Secondary Outcome Measure.
The classification of EULAR response and the calculation of DAS28-CRP are based on above of Primary Outcome Measure.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- signed the consents voluntarily
- age between 18-75 years old
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878161
Principal Investigator: | Fen Li, doctor | Central South University |
Responsible Party: | Fen Li, associate chief physician, Central South University |
ClinicalTrials.gov Identifier: | NCT02878161 |
Other Study ID Numbers: |
XYEYY-GZ81571599-20160118-1 |
First Posted: | August 25, 2016 Key Record Dates |
Last Update Posted: | August 25, 2016 |
Last Verified: | July 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
rheumatoid arthritis tumor necrosis factor α inhibitor predictive iTRAQ signal pathway |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Prednisone Methylprednisolone Adalimumab Etanercept Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Methotrexate |
Infliximab Glucocorticoids Leflunomide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Dermatologic Agents |