A Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero – Adalimumab

Hetero Biopharma Limited0 个研究点目标入组 200 人开始时间: 待定最近更新: 2023年12月19日

试验速览

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•1. The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
•2. Male and female adult patients, 18 years or older.
•3. Patients with the any one of the following indications
•o Rheumatoid Arthritis (RA)
•o Juvenile Idiopathic Arthritis (JIA)
•o Axial Spondyloarthritis (AS)
•o Psoriatic Arthritis (PsA)
•o Psoriasis
•o Paediatric Plaque Psoriasis
•o Hidradenitis Suppurativa (HS)
•o Crohns disease
•o Paediatric Crohns disease
•o Ulcerative Colitis
•4. Any other patients indicated Adalimumab as per investigators discretion according to the prescribing information.
•5. Patients who have not taken any biologic agents including Adalimumab previously

•1. Patients with clinical history/ evidence of allergy/hypersensitivity to active substance or to any of the excipients of Hetero-Adalimumab.
•2. Patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections.
•3. Patients with moderate to severe heart failure (NYHA class III/IV)
•4. Receipt of live vaccine within 4 weeks prior to study drug administration
•5. Current medical history/clinical evidence of hepatitis B or hepatitis C infection or HIV
•6. Patients who are likely to be pregnant or lactating patients.
•7. Patients with history or pre-existing clinical evidence of medically significant abnormality or requirements for surgery that precludes the usage of Hetero-Adalimumab, as
•per investigators discretion

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