A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of AdaliRel® in patients with moderate to severe plaque psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
- 试验地点
- 17
- 主要终点
- Incidence of adverse events occurring during the study
研究概览
简要总结
Psoriasis is an immune mediated genetically determined common dermatological disorder which affects skin, nails, joints and has various systemic associations. There is a growing number of population-based studies providing worldwide prevalence estimates of psoriasis. Prevalence of psoriasis varies in different parts of the world. According to published reports, prevalence in different populations varies from 0% to 11.8%. For most of the data given, the range extends from around 0.5% to close to 2.5%. In the USA, the prevalence of psoriasis was estimated to be around 4.6% while in Canada it was 4.7%. Data from Europe show little variation in countries with a range from 1.4% (Norway), 1.55% (Croatia) and 1.6% (UK). In East Africa, the figure was 0.7% and in the Henan district of China only 0.7% were found affected.
Adalimumab is the first fully human, high-affinity, recombinant immunoglobulin G1 (IgG1) anti-TNF monoclonal antibody. Adalimumab was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. Because it is indistinguishable in structure and function from naturally occurring human IgG1, adalimumab has high selectivity and affinity for TNF; suitability for long-term chronic administration with a low degree of immunogenicity, with or without concomitant methotrexate (MTX) use; a low incidence of allergic reactions; and a half-life comparable to that of IgG1, allowing every-other-week dosing for patient convenience.
AdaliRel® is a similar biological medicinal product to the innovator product. AdaliRel® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
This prospective, multi-centre, open label, phase IV study has been designed to evaluate the safety and efficacy of InfimabTM in patients with moderate to severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 65 years (both inclusive)
- •Patients with confirmed diagnosis of plaque psoriasis since at least 6 months
- •Patients with moderate to severe plaque psoriasis with ≥10% BSA involvement and PASI ≥12
- •Physician’s Global Assessment (PGA) of at least moderate disease severity
- •Women of childbearing potential and men agreeing to use adequate contraception
- •Patients able to understand and willing to provide written informed consent.
排除标准
- •Patients with hypersensitivity to Adalimumab or any of its components.
- •Pregnant or lactating females
- •Presence of serious or active infection due to bacteria, fungi, viruses or other opportunistic pathogens
- •History of serious infection, which caused hospitalization within 6 months prior to randomization or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection such as histoplasmosis, or a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment.
- •Infection requiring parenteral antibiotic treatment within 4 weeks of randomization.
- •Patients with history of any malignancy diagnosed within last 5 years or presence of any premalignant lesions
- •Patients with heart failure (New York Heart Association class III or IV)
- •Patients with known hematological disorders, demyelinating disease or lupus-like syndrome
- •Patients with known clinically significant liver disease
- •Known cases of HIV, Hepatitis B or Hepatitis C infection
- •Also excluded are subjects who have evidence of latent TB [evidence of tuberculosis based on chest X rays, tuberculin skin (Mantoux) test, QuantiFERON®-TB Gold test or other tuberculosis test performed during screening] without adequate therapy for TB completed prior to first infusion of Study Medication.
- •Also excluded are subjects with evidence of an old or latent TB infection without documented adequate therapy, if they will not be treated with antitubercular therapy during the study.
- •Subjects with a current close contact with an individual with active TB will also be excluded.
- •Additionally, subjects who have completed treatment for active TB within the previous 2 years are explicitly excluded from the study.
- •Subjects with a household member who has a history of active pulmonary TB, which has been treated, should have had a thorough evaluation for TB prior to study enrolment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies.
- •Also excluded are subjects with opportunistic infections including, but not limited to, evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc., within the previous 6 months.
- •Patients with any condition that might make it difficult for patients to participate in the study or that might affect interpretation of results of the study, at the discretion of Investigator.
- •Participation in any clinical study of an investigational product within previous 3 months.
- •Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study.
结局指标
主要结局
Incidence of adverse events occurring during the study
时间窗: throughout the study
次要结局
- Percentage of patients achieving PASI 50/75/90/100 response from baseline to week 16(week 16)
- Mean percentage PASI score improvement from baseline to week 16
- Percentage of patient achieving Physician Global Assessment (PGA) score clear/clear or minimal from baseline to week 16(week 16)