Health Condition 1: L405- Arthropathic psoriasis Health Condition 2: M468- Other specified inflammatory spondylopathies Health Condition 3: L409- Psoriasis, unspecified Health Condition 4: null- Rheumatoid Arthritis (RA), Axial Spondyloarthritis (AS), Psoriatic Arthritis (PsA), Psoriasis Health Condition 5: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Hetero-Adalimumab
0.8mL pre-filled syringe
Each single-use pre-filled syringe contains 40mg of Adalimumab: Subcutaneous injection for 12 to 24 weeks. Frequency of administration is base
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, outcome, duration, action taken, and causality of individual adverse events reported during the studyTimepoint: Screening, at the end of 12 weeks, 6 months, 9 months and 12 months or end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy- Change in efficacyTimepoint: Baseline to end of 12 weeks, 6 months, 9 months and 12 months or end of study;Immunogenicity - development and change in antidrug antibodies (ADA) titer against Hetero–AdalimumabTimepoint: Baseline, at the end of 12 weeks, 6 months, 9 months and 12 months or end of the study | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Labs Limited
Outcome results
None listed