Health Condition 1: M459- Ankylosing spondylitis of unspecified sites in spine Health Condition 2: M089- Juvenile arthritis, unspecified Health Condition 3: M138- Other specified arthritis Health Condition 4: L409- Psoriasis, unspecified Health Condition 5: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: EtanerRel: The EtanerRelTM will be supplied by Reliance Life Sciences Pvt. Ltd. It will be administered to the study subjects by a designated person. In this study, EtanerRelTM 25 mg vi
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to etanercept or any component of the formulation, Chinese hamster ovary cell products or other recombinant human or humanized antibodies 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 treatment. 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 syndrome 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 months. 16. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety of EtanerRel.Timepoint: 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] | — |
Secondary
| Measure | Time frame |
|---|---|
| • Ankylosing spondylitis - Proportion of patients achieving ASAS 20, ASAS 40, ASAS 50 and ASAS 70 from baseline across visits - Proportion of patients achieving ASAS 5/6 from baseline across visits - Change in the BASDAI score from baseline across visits - Change in CRP and ESR level from baseline across visits Timepoint: 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];• Plaque psoriasis - Proportion of patients achieving PASI 50/75/90/100 response from baseline across visits - Proportion of patients achieving Physician Global Assessment (PGA) score clear/clear or minimal from baseline across visits Timepoint: 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];• 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 - Proportion of patients with disease flare across visits - Change in JADAS71 score from baseline across visits Timepoint: 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];• Psoriatic arthritis - Proportion of patients achieving the ACR 20, 50, and 70 response across visits - Proportion of patients achieving PASI 50/75/90/100 response from baseline across visits - Change in HAQ-DI score from baseline across visits Timepoint: 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];• Rheumatoid arthritis: - Proportion of patients achieving clinical response according to the ACR20, ACR50 and ACR70 criter | — |
Countries
India
Contacts
Public ContactVikram Jadhav
Reliance Life Sciences Pvt. Ltd. (RLS)
Outcome results
None listed