A Phase 3 interventional study of etanercept and etanercept (half dose) in Plaque Psoriasis and Psoriasis, sponsored by Shanghai Celgen Bio-Pharmaceutical Co.,Ltd. Status unknown at 4 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Shanghai Celgen Bio-Pharmaceutical Co.,Ltd · Phase 3, Interventional, and Treatment
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke®. And the second purpose is to assess the efficacy and safety of Qiangke® in Moderate to Severe Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and at the first stage they will be randomized divided into three group: full-dose of Qiangke® group, half-dose of Qiangke® group and placebo group.And the blind stage will last for 12 weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke® for additional 12 weeks.
Psoriasis is a chronic inflammatory skin disease that can lead to significant physical and psychologic distress for patients.Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) can block the role of the cytokine tumor necrosis factor (TNF)-alpha.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's planned enrollment of 216 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →This is the only study on the registry with Shanghai Celgen Bio-Pharmaceutical Co.,Ltd as lead sponsor.
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Exclusion Criteria:
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
Biological: etanercept
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
Biological: etanercept (half dose)
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
Drug: placebo
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.
Also known as: Qiangke®
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.
Also known as: Qiangke®
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.
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
Time frame: Week 12
Proportion of subjects achieving PASI 90 & 50
Time frame: Week 12
Proportion of subjects achieving PASI 90 & 50 & 75
Time frame: Week 24
Physician's Global Assessment (PGA)
Time frame: Week 12 & 24
Nail Psoriasis Severity Index (NAPSI)
Time frame: Week 12 & 24
Dermatology Life Quality Index (DLQI)
Time frame: Week 12 & 24
Patient's Global Assessment (PGA)
Time frame: Week 12 & 24
Safety parameters - Number of Participants With Abnormal Laboratory Values and/or Adverse Events
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time frame: Week 12 & 24
Plan to share: Undecided
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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