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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 =6.
- •- Active rheumatoid arthritis defined as:
- •- =6 swollen joints
- •- =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
- •- Patients aged 18 years or older.
- •- 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
- •- Patients aged 18 years or older.
- •- 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 = 3
- •- 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.
- •3. Women of childbearing potential must agree to use adequate contraception
- •4. Patients willing to provide written assent/ informed consent.
排除标准
- •1. Patients with hypersensitivity to etanercept or any component of the formulation,
- •Chinese hamster ovary cell products or other recombinant human or humanized
- •2. Pregnant or lactating females
- •3. 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
- •4. 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
- •5. Infection requiring parenteral antibiotic treatment within 4 weeks of enrolment.
- •6. Patients with history of any malignancy including lymphomas, leukemia or
- •presence of any premalignant lesions
- •7. Patients with heart failure (New York Heart Association class III or IV)
- •8. Patients with known hematological disorders, demyelinating disease or lupus-like
- •9. Patients with clinically significant liver disease
- •10. Known cases of HIV, Hepatitis B or Hepatitis C infection
- •11. Active TB. 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.
- •12. 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
- •13. Patients currently on cyclophosphamide, anakinra or abatacept therapy
- •14. Patients with moderate to severe alcoholic hepatitis
- •15. Participation in any clinical study of an investigational product within previous 3
- •16. Current signs or symptoms of significant, progressive or uncontrolled renal,
- •hepatic, hematologic, gastrointestinal, endocrine,
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