A clinical trial to study the safety and efficacy of Biosimilar Adalimumab injection versus HUMIRA® in subjects with active Ankylosing spondylitis .

Phase 3

Completed

• Conditions: Ankylosing spondylitis of unspecified sites in spine,

• Registration Number: CTRI/2020/09/028070
• Lead Sponsor: Enzene Biosciences Limited

Brief Summary

A prospective, multicenter, randomized, double blind, Phase III study to compare the efficacy and safety of Biosimilar Adalimumab injection of Enzene Biosciences Ltd. with HUMIRA® (adalimumab) injection in subjects with active Ankylosing spondylitis (AS).

Primary Objective:  To compare the efficacy of Biosimilar Adalimumab injection with HUMIRA® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteria

Secondary Objective(s):



To evaluate the following: 1. Pharmacokinetics (PK) of Biosimilar versus HUMIRA® (adalimumab) injection

2. Immunogenicity of Biosimilar and HUMIRA® (adalimumab) injection by assessment of anti-Adalimumab antibody

3. Safety and tolerability of the investigational product

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Male or Female subjects between 18 to 65 years of age 2.
• Subjects with diagnosis of Axial Ankylosing spondylitis based on the 1984 modified New York classification criteria, has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits: a.
• BASDAI score ≥ 4 b.
• Total back pain on a visual analog scale ≥ 4 c.
• Morning stiffness ≥ 1 hour 4.
• Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as assessed by the Investigator 5.
• Willing and able to comply with the protocol.

Exclusion Criteria

• Has total spinal ankylosis 2.
• Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to screening 3.
• Has received intra-articular joint injection(s), spinal or paraspinal corticosteroid injection(s) within 28 days prior to Baseline 4.
• Has prior exposure to any anti-TNF therapy at any time 5.
• Subjects with clinically active TB 6.
• Subjects with underlying conditions that may predispose them to infection 7.
• Subjects with history or presence of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, or hepatic disease which in the opinion of the investigator does not allow participation of the subject in this study 8.
• Known hypersensitivity to any component of the investigational product and other medications used in this study 9.
• Subjects with a non-healed fracture 10.
• Subject’s having the following laboratory results at screening a.
• Absolute neutrophil count (ANC) < 1,500/mm3 b.
• Hemoglobin (Hb) <10 g/dL c.
• Platelet count < 100,000/mm3 d.
• Total bilirubin level > 1.5 times the upper limit of the normal laboratory range (ULN) e.
• AST and ALT >3 x ULN f.
• Alkaline phosphatase >3 x ULN g.
• Serum Creatinine level > 1.25 xULN 11.
• Subjects suffering from acute or chronic infection(s) 12.
• Subjects with congestive heart failure 13.
• Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening 14.
• Subjects of child bearing potential, who are not willing to use adequate contraception during the study period.
• Female subjects who are pregnant or nursing 16.
• Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the subject in this study 17.
• Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of Biosimilar Adalimumab injection with HUMIRA® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteria	All subject completing till week 12

Secondary Outcome Measures

Name	Time	Method
1. Pharmacokinetics (PK) of Biosimilar versus HUMIRA® (adalimumab) injection	2. Immunogenicity of Biosimilar and HUMIRA® (adalimumab) injection by assessment of anti-Adalimumab antibody

Trial Locations

Locations (29)

Akash Healthcare Super Specilaity Hopsital; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

All India Institute of Medical Sciences, Delhi; 🇮🇳 Delhi, DELHI, India

Amrita Institue of Medical Science and Resrach Centre; 🇮🇳 Ernakulam, KERALA, India

Andhra Medical College, King George Hospital, Visakhapatnam; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Avron Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

B J Medical College and Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Chanre Rheumatology and Immunology Centre and Research; 🇮🇳 Bangalore, KARNATAKA, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Government Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

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Akash Healthcare Super Specilaity Hopsital

🇮🇳Delhi, DELHI, India

Dr Gaurav Seth

Principal investigator

9871446609

gauravmarch18@gmail.com