A study to examine the side effects and benefits of Hetero - Adalimumab
- Conditions
- Health Condition 1: L405- Arthropathic psoriasisHealth Condition 2: M468- Other specified inflammatory spondylopathiesHealth Condition 3: L409- Psoriasis, unspecifiedHealth Condition 4: null- Rheumatoid Arthritis (RA), Axial Spondyloarthritis (AS), Psoriatic Arthritis (PsA), PsoriasisHealth Condition 5: M069- Rheumatoid arthritis, unspecified
- Registration Number
- CTRI/2018/06/014661
- Lead Sponsor
- Hetero Biopharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
o Uveitis
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method