Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease (GIANT)

Sandoz

Status: Completed

Conditions: Crohn´s Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03890445

CGPN017A2001

Details and patient eligibility

About

Hyrimoz™ was developed as a biosimilar to HumiraTM (INN: adalimumab) and Zessly™ was developed as a biosimilar to RemicadeTM (INN: infliximab). Within the Biosimilar Development Program of Hyrimoz™ and Zessly™, two clinical confirmatory efficacy and safety studies were conducted: Hyrimoz™ in plaque psoriasis and Zessly™ in rheumatoid arthritis. Both confirmatory Phase III studies demonstrated equivalent efficacy and similar safety and immunogenicity of Hyrimoz™ to HumiraTM and Zessly™ to RemicadeTM, respectively.

The current study is designed to provide a systematic and consistent overview of the real-world data in biologic-naïve patients with moderate-to-severe Crohn's disease (CD). The data collected in this observational trial will be used to increase the knowledge of the effectiveness of Hyrimoz™ and Zessly™ in clinical routine care in patients with moderate-to-severe CD.

Enrollment: 63 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion and exclusion criteria are to ensure the enrollment of patients receiving the drug according to the label of Hyrimoz™ and the label of Zessly™. Patients observed in this study need to meet all of the following inclusion criteria and none of the exclusion criteria at enrollment:

Inclusion criteria

1. Confirmed diagnosis of CD
2. Harvey-Bradshaw Index (HBI) ≥ 5
3. Treatment failure upon steroids / topical budesonide with or without immunosuppressants
4. Males and females ≥ 18 years of age at enrollment
5. Biologic-naive patients scheduled to receive Hyrimoz™ or Zessly™ and patients already receiving Hyrimoz™ or Zessly™ according to the label and at the discretion of the investigator for up to three months prior enrollment
6. Provision of signed informed consent form

Exclusion criteria

1. Patients with CD in clinical remission (HBI < 5)
2. Hemoglobin < 8.5 g/dL
3. Patients at imminent risk of scheduled intestinal surgery (stenosis, strictures, internal fistula)
4. Any contraindications to Hyrimoz™ or Zessly™ according to the prescribing recommendations in each country
5. Participation in an interventional clinical trial for immune-mediated inflammatory diseases (IMIDs) or having received any investigational agent or procedure within 30 days prior to enrollment (consenting)

Trial design

63 participants in 2 patient groups

Adalimumab Biosimilar (Hyrimoz)

Description:

Patients with moderate-to-severe CD receiving Hyrimoz™ treatment according to the Hyrimoz™ label at the discretion of the investigator

Infliximab Biosimilar (Zessly)

Description:

Patients with moderate-to-severe CD receiving Zessly™ treatment according to the Zessly™ label at the discretion of the investigator