CTRI/2021/06/034073 [Registered on: 08/06/2021] Trial Registered Prospectively
Last Modified On:
17/01/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Single Arm Study
Public Title of Study
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)
Scientific Title of Study
A prospective, multi-centre, phase IV study to evaluate safety and efficacy of EtanerRelTM (etanercept manufactured by Reliance Life Sciences Pvt. Ltd.)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
RLS/PMS/2018/03, Version 3.0, Dated 14th Oct 2019
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Ganesh Bagul
Designation
Head - Clinical Operations
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences
Centre, Dept/Division: Clinical Research, Room number -B22(DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences
Centre, Dept/Division: Clinical Research, Room number -B22(DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences
Centre, Dept/Division: Clinical Research, Room number -B22(DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai
Thane MAHARASHTRA 400701 India
Phone
Fax
Email
Vikram.Jadhav@relbio.com
Source of Monetary or Material Support
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences
Centre, Dept/Division: Clinical Research, Room number -B22(DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai
Primary Sponsor
Name
Reliance Life Sciences Pvt Ltd
Address
R-282, TTC Area of MIDC Thane - Belapur Road, Rabale, Navi Mumbai - 400701, Maharashtra, INDIA
401,402, 4th floor, Santorini Square, Opp star Bazzar, Behind abhishree complex, Near jodhpur cross road, Satellite road, Ahmedabad Ahmadabad GUJARAT
8511555477
drvishnusharma@yahoo.co.in
Dr Manojkumar Katragadda
Andhra Medical College/King George Hospital, Visakhapatnam
Room#1 Research room, Andhra Medical College
King George Hospital, Maharanipeta,
Visakhapatnam-530002
India
Visakhapatnam ANDHRA PRADESH
9010223228
drkmanojkumaresearch@gmail.com
Dr Syamasis Bandyopadhyay
Apollo Gleneagles Hospital
Department and Div: Clinical trials and Research, Room#: 4th floor daycare bldg. Apollo Gleneagles Hospital,
58 Canal Circular Road,
Kolkata - 700054
West Bengal, India
Kolkata WEST BENGAL
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 vial and 50 mg pre-filled syringe (PFS) will be supplied.
1).Dose and frequency:
a). Adult RA, AS and PsA: 50 mg weekly.
b). Adult PsO : Starting Dose 50 mg Twice weekly for 3 months, Maintenance Dose : 50 mg once weekly.
c). Pediatric dose(PsO or JIA): 63kg (138 pounds) or more recommended dose - 50 mg weekly, for patients Less than 63kg (138 pounds) recommended dose - 0.8mg/kg weekly.
2). Route of administration: Subcutaneous Injection.
and
3). Duration of therapy: 23 weeks
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
2.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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, pulmonary, cardiac, neurologic or
cerebral disease that renders the patient incapable of participating in the study.
• Rheumatoid arthritis:
- Proportion of patients achieving clinical response according to the ACR20, ACR50 and ACR70 criteria across visits
- Change in DAS28 and HAQ-DI score from baseline across visits
- Changes in CRP and ESR level from baseline across visits
- Changes in Rheumatoid Factor from baseline 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
- Proportion of patients with disease flare across visits
- Change in JADAS71 score from baseline across visits
• 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
• 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
• 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
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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