Safety and Efficacy Study of Etanercept (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis
NCT ID: NCT02701205
Last Updated: 2016-03-08
Study Results
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Basic Information
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UNKNOWN
PHASE3
216 participants
INTERVENTIONAL
2015-01-31
2017-12-31
Brief Summary
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Detailed Description
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TNF-α plays a major role in the pathophysiology of both Psoriasis（PsO）and Psoriatic Arthritis (PsA). TNF-α levels are elevated in psoriatic skin lesions, serum samples, and synovial fluid. Anti-TNF-α therapy has shown efficacy in treating psoriatic skin lesions, joint pain and swelling, enthesitis, and dactylitis plus the ability to improve mobility, reduce radiographic progression of disease, and influence quality of life parameters.
Qiangke® is a dimeric, soluble fusion protein consisting of the extracellular ligand binding portion of the TNF receptor linked to the Fc portion of human Immunoglobulin gamma-1（IgG1）. It is capable of binding and neutralizing soluble TNF and transmembrane TNF. It alters neutrophil migration and dendritic cell and T-cell maturation and migration, thus decreasing the local and systemic production of pro-inflammatory cytokines and their subsequent effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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etanercept
Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 50mg twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24
etanercept
Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
etanercept (half dose)
One vial of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®） 25mg and one vial of placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24
etanercept (half dose)
Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
Placebo
Two vials of Placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 25mg twice a week from Week 12 to Week 24
placebo
two vials of placebo twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
Interventions
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etanercept
Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
etanercept (half dose)
Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
placebo
two vials of placebo twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Freely provides both verbal and written informed consent.
3. Consent to use effective contraception during the trial period.
4. Participant had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
5. Participant must have a Psoriasis Area Severity Index score greater than or equal to 12 at the baseline visit and Body Surface Area involvement greater than or equal to 10% at the baseline visit.
6. Participant has previous exposure to systemic psoriasis therapy or phototherapy, but not ideal.
7. Meet the following criteria for Tuberculosis screening: A. has no prior history of occult or active tuberculosis. B. No signs or symptoms of active tuberculosis in history and / or physical examination. C. in the first 6 weeks of the trial, tuberculosis screening test meet the requirements of the trial.
8. Laboratory screening results:Hemoglobin≥110g/L.White blood cell≥4 \* 109 /L. Neutrophil≥1.5 \* 109/L.Platelet≥100 \* 109/L.Serum alanine aminotransferase and / or aspartate aminotransferase not more than 1.5 times of the upper limit of normal.Serum creatinine does not exceed 1.5 mg/dL (International units: ≤133 mol/L).
9. During the first 2 weeks of the study, Participant must stop adjuvant therapy including traditional Chinese medicine and acupuncture.
10. Hepatitis B (HBV) screening in compliance with the requirements of this test.
11. Weight≥60Kg.
Exclusion Criteria
2. Participant had treated with TNF antagonists within 6 weeks prior to the Baseline visit.
3. Participant had treated with Other biological agents within 6 weeks prior to the Baseline visit.
4. Participant had treated with Phototherapy or systemic antipsoriatic treatment (such as:Methotrexate（MTX）， acitretin, cyclosporine, Total Glucosides of Paeony（TGP）, treatment of psoriasis related Chinese medicines, etc.) and systemic corticosteroid treatment within 4 weeks prior to the Baseline visit.
5. Participant had treated with Topical corticosteroid therapy, vitamin A or D analogue or Anthralin within 2 weeks prior to the Baseline visit.
6. Participant received any drug that the drug's metabolism was less than 7 half lives before the Baseline visit.
7. Participant plans to pregnant or breast feeding or father during the study.
8. The history of occult or active granuloma infections, including histoplasmosis, coccidioidomycosis.
9. Participant has suffered from Non Mycobacterium tuberculosis infection or opportunistic infections (such as cytomegalovirus sense of dyeing, Pneumocystis carinii pneumonia, aspergillosis) within 6 weeks prior to the Baseline visit.
10. The close contact history of active tuberculosis patients or Tuberculosis screening results do not meet the requirements.
11. Participant has suffered from severe infection (for example hepatitis, pneumonia, acute pyelonephritis or sepsis), or participant use intravenous antibiotics now because of infection within 6 weeks prior to the Baseline visit.
12. Participant has suffered from chronic or recurrent infections before or at present, including (but not limited to) chronic kidney infection disease and chronic chest infectious diseases (such as bronchial dilation), sinusitis, recurrent urinary tract infections (such as recurrent pyelonephritis and chronic non remission cystitis), open, overflow liquid or infection of skin wound or ulcer.
13. Human immunodeficiency virus (HIV) antibody positive.
14. Hepatitis B virus (HBV) screening results do not meet the requirements.
15. Hepatitis C virus (HCV) antibody positive.
16. Participant has demyelinating diseases such as multiple sclerosis or optic neuritis.
17. A history of congestive heart failure, including asymptomatic congestive heart failure.
18. A history or sign of a lymph node hyperplasia, including lymphoma or suggestive of a possible sign such as the size and location of an enlarged lymph node or a history of clinically significant enlargement of the spleen.
19. Participant has symptoms or signs of severe, progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, nerve, mental or brain diseases.
20. There is a history of malignancy or previous history.
21. Joint prosthesis has not yet been removed or replaced.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Celgen Bio-Pharmaceutical Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Hongzhong Jin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences Peking Union Medical College
Locations
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Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Institute of Dermatology and Skin Disease Hospital Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Changhai Hospital of The Second Military Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hongzhong Jin, M.D.
Role: primary
Heng Gu, M.D.
Role: primary
Qing Sun, M.D.
Role: primary
Jun Gu, M.D.
Role: primary
References
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Gottlieb AB, Chamian F, Masud S, Cardinale I, Abello MV, Lowes MA, Chen F, Magliocco M, Krueger JG. TNF inhibition rapidly down-regulates multiple proinflammatory pathways in psoriasis plaques. J Immunol. 2005 Aug 15;175(4):2721-9. doi: 10.4049/jimmunol.175.4.2721.
Gudjonsson JE, Elder JT. Psoriasis: epidemiology. Clin Dermatol. 2007 Nov-Dec;25(6):535-46. doi: 10.1016/j.clindermatol.2007.08.007.
Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x.
Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, Gottlieb AB; Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003 Nov 20;349(21):2014-22. doi: 10.1056/NEJMoa030409.
Kivelevitch D, Mansouri B, Menter A. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis. Biologics. 2014 Apr 17;8:169-82. doi: 10.2147/BTT.S41481. eCollection 2014.
Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CE, Nakanishi AM, Zitnik R, van de Kerkhof PC, Melvin L; Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005 Jun;152(6):1304-12. doi: 10.1111/j.1365-2133.2005.06688.x.
Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.
Chiu HY, Wang TS, Cho YT, Tsai TF. Etanercept use for psoriasis in Taiwan: a case series study. Int J Dermatol. 2013 Jun;52(6):673-80. doi: 10.1111/j.1365-4632.2011.05273.x. Epub 2012 Feb 20.
Other Identifiers
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QRSTPP
Identifier Type: -
Identifier Source: org_study_id
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