Clinical trial · Interventional
Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"
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
NCT02878161CI-TRIAL-00023648unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adalimumab | Biological | — | UNRESOLVED |
| etanercept | Biological | — | UNRESOLVED |
| Glucocorticoids (permitted,not necessary) | Drug | — | UNRESOLVED |
| infliximab | Biological | — | UNRESOLVED |
| leflunomide (permitted, not necessary) | Drug | — | UNRESOLVED |
| methotrexate(necessary) | Drug | Methotrexate | ALIAS |
| NSAIDs (permitted,not necessary) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A group
- description
- Infliximab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.
- interventionNames
- Drug: methotrexate(necessary)
- Biological: infliximab
- Drug: leflunomide (permitted, not necessary)
- Drug: NSAIDs (permitted,not necessary)
- Drug: Glucocorticoids (permitted,not necessary)
- type
- EXPERIMENTAL
- label
- B group
- description
- Etanercept plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.
- interventionNames
- Drug: methotrexate(necessary)
- Biological: etanercept
- Drug: leflunomide (permitted, not necessary)
- Drug: NSAIDs (permitted,not necessary)
- Drug: Glucocorticoids (permitted,not necessary)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (43)
- BACKGROUNDvan Vollenhoven RF. Switching between anti-tumour necrosis factors: trying to get a handle on a complex issue. Ann Rheum Dis. 2007 Jul;66(7):849-51. doi: 10.1136/ard.2007.069872. PMID 17576784
- BACKGROUNDRadstake TR, Svenson M, Eijsbouts AM, van den Hoogen FH, Enevold C, van Riel PL, Bendtzen K. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis. 2009 Nov;68(11):1739-45. doi: 10.1136/ard.2008.092833. Epub 2008 Nov 19. PMID 19019895
- BACKGROUNDMiossec P, Verweij CL, Klareskog L, Pitzalis C, Barton A, Lekkerkerker F, Reiter S, Laslop A, Breedveld F, Abadie E, Flamion B, Dere W, Mpofu S, Goel N, Ethgen D, Mitlak B, Ormarsdottir S, Rao R, Tsouderos Y, Reginster JY; Group for Respect of Ethics and Excellence in Science (GREES). Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies. Ann Rheum Dis. 2011 Oct;70(10):1713-8. doi: 10.1136/ard.2011.154252. Epub 2011 Jul 22. PMID 21784723
- BACKGROUNDZeng Z, Duan Z, Zhang T, Wang S, Li G, Gao J, Ye D, Xu S, Xu J, Zhang L, Pan F. Association between tumor necrosis factor-alpha (TNF-alpha) promoter -308 G/A and response to TNF-alpha blockers in rheumatoid arthritis: a meta-analysis. Mod Rheumatol. 2013 May;23(3):489-95. doi: 10.1007/s10165-012-0699-5. Epub 2012 Jul 4. PMID 22760475
- BACKGROUNDKang CP, Lee KW, Yoo DH, Kang C, Bae SC. The influence of a polymorphism at position -857 of the tumour necrosis factor alpha gene on clinical response to etanercept therapy in rheumatoid arthritis. Rheumatology (Oxford). 2005 Apr;44(4):547-52. doi: 10.1093/rheumatology/keh550. Epub 2005 Feb 3. PMID 15695296
- BACKGROUNDMiceli-Richard C, Comets E, Verstuyft C, Tamouza R, Loiseau P, Ravaud P, Kupper H, Becquemont L, Charron D, Mariette X. A single tumour necrosis factor haplotype influences the response to adalimumab in rheumatoid arthritis. Ann Rheum Dis. 2008 Apr;67(4):478-84. doi: 10.1136/ard.2007.074104. Epub 2007 Aug 2.