The purpose of this research study is to evaluate the safety and effectiveness profile of the medicine named as EtanerRelTM in patients with different type of arthritis (joint pain)
- Conditions
- Health Condition 1: M459- Ankylosing spondylitis of unspecified sites in spineHealth Condition 2: M089- Juvenile arthritis, unspecifiedHealth Condition 3: M138- Other specified arthritisHealth Condition 4: L409- Psoriasis, unspecifiedHealth Condition 5: M069- Rheumatoid arthritis, unspecified
- Registration Number
- CTRI/2021/06/034073
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
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.
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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br/ ><br>[Wk is Week]
- Secondary Outcome Measures
Name Time Method