CTRI/2021/06/034073已完成4 期
A prospective, multi-centre, phase IV study to evaluate safety and efficacy of EtanerRelTM (etanercept manufactured by Reliance Life Sciences Pvt. Ltd.)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 15
- 主要终点
- To evaluate safety of EtanerRel.
研究概览
简要总结
The purpose of this trial is to evaluate the safety and efficacy profile of EtanerRelTM in patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis or plaque psoriasis as defined below – Rheumatoid arthritis.
- •Patients aged 18 years or older.
- •Diagnosis of Rheumatoid Arthritis according to the criteria based on the revised 2010 American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria for Rheumatoid Arthritis.
- •ACR/EULAR diagnostic criteria score ≥
- •Active rheumatoid arthritis defined as:.
- •â‰¥6 swollen joints.
- •â‰¥6 tender joints and c.Acute phase reactant values (CRP >8 mg/L or ESR >28 mm/h) Juvenile idiopathic arthritis.
- •Patients aged 2 years or older.
- •Moderately to severely active polyarticular-course juvenile idiopathic arthritis Psoriatic arthritis.
- •Active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
- •Patients with plaque psoriasis with a lesion ≥ 2 cm in diameter. Ankylosing spondylitis.
- •Active ankylosing spondylitis defined as: a. Visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus b.VAS scores of ≥ 30 for at least 2 of the following 3 parameters: -patient global assessment; -average of VAS values for nocturnal back pain and total back pain; -average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI). Plaque psoriasis:.
- •Patients aged 4 years or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- •static Physician Global Assessment (sPGA) score ≥
- •Plaque psoriasis involving ≥ 10% of the body surface area.
- •Psoriasis area and severity index (PASI) of ≥ 10 2.Patients must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
- •Women of childbearing potential must agree to use adequate contraception
- •Patients willing to provide written assent/ informed consent.
排除标准
- •Patients with hypersensitivity to etanercept or any component of the formulation, Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- •Pregnant or lactating females
- •Presence of serious or active infection due to bacterial, mycobacterial, invasive, fungal, viral, parasitic or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis
- •History of serious infection, which caused hospitalization within 6 months prior to enrolment 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 enrolment.
- •Patients with history of any malignancy including lymphomas, leukemia 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 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.
- •Subjects who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the etanercept therapy, e.g., Lyme disease
- •Patients currently on cyclophosphamide, anakinra or abatacept therapy
- •Patients with moderate to severe alcoholic hepatitis
- •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
To evaluate safety of EtanerRel.
时间窗: Day 0, Wk1, Wk2, Wk3, Wk4, Wk5, Wk6, Wk7, Wk8, Wk9, Wk10, Wk11, Wk12, Wk13, Wk14,Wk15, Wk16, Wk17, Wk18, Wk19, Wk20, Wk21, Wk22, Wk23, Wk24, Wk48 (SAFETY FOLLOW UP). | [Wk is Week]
次要结局
- To evaluate efficacy of EtanerRelTM(Day 0, Wk1, Wk2, Wk3, Wk4, Wk5, Wk6, Wk7, Wk8, Wk9, Wk10, Wk11, Wk12, Wk13, Wk14,Wk15, Wk16, Wk17, Wk18, Wk19, Wk20, Wk21, Wk22, Wk23, Wk24, Wk48 (SAFETY FOLLOW UP).)
- •Rheumatoid arthritis:(- Proportion of patients achieving clinical response according to the ACR20, ACR50 and ACR70 criteria across visits)
- •Polyarticular juvenile idiopathic arthritis(- Proportion of patients achieving ACR Pedi 30, ACR Pedi 20, ACR Pedi 50, and ACR Pedi 70 response at across visits)
- •Psoriatic arthritis(- Proportion of patients achieving the ACR 20, 50, and 70 response across visits)
- •Ankylosing spondylitis(- Proportion of patients achieving ASAS 20, ASAS 40, ASAS 50 and ASAS 70 from baseline across visits)
- •Plaque psoriasis(- Proportion of patients achieving PASI 50/75/90/100 response from baseline across visits)
研究者
研究点 (15)
Loading locations...
相似试验
进行中（未招募）
Unknown
The post marketing clinical research on drug Tenecteplase in patients with ST segment elevation myocardial infarction or left bundle branch blockCTRI/2020/07/026356Reliance Life Sciences Pvt Ltd202
终止
4 期
Pilot Study Evaluating The Efficacy Of Etanercept In Acute GoutGout AttackNCT03636373Rutgers, The State University of New Jersey5
Unknown
2 期
Etanercept (Enbrel) in Ankylosing SpondylitisAnkylosing SpondylitisNCT01289743Charite University, Berlin, Germany24
已完成
2 期
Safety and Tolerability of Etanercept in Alzheimer's DiseaseAlzheimer's DiseaseNCT01068353University of Southampton41
Unknown
2 期
Etanercept (Enbrel) in Undifferentiated SpondyloarthritisSpondyloarthritisNCT01289730Charite University, Berlin, Germany8