Vedolizumab-4020: A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn’s Disease

Study identification

• EU PAS number:
  EUPAS23702
• Study ID:
  45304
• Official title and acronym:
  Vedolizumab-4020: A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn’s Disease
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  Vedolizumab is a medicine that helps to reduce sensitivity and pain in the digestive system. In this study, people with ulcerative colitis or Crohn’s disease will be treated with vedolizumab. The main aim of the study is to check for side effects from Vedolizumab. At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment. Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Osmania General Hospital, Hyderabad, India, Sunshine Institute for Gastroenterology, Liver Diseases and Minimal Invasive Surgery, Telangana, India, Shree Giriraj Multispecality Hospital, Surat Institute of Digestive Sciences, Apollo Hospital International Ltd Gujarat, India, Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh, India, Indira Gandhi Institute of Medical Sciences Bihar, India, Gandhi Hospital Secunderabad, India, Lakeshore Hospital and Research Centre Ltd, Aster Medcity, Aster DM Healthcare Pvt Ltd, Amrita Institute of Medical Sciences Kerala, India, VGM Hospital, Institute of Gastroenterology Coimbatore, India, Institute of Medical Gastroenterology (IMG). Madras Medical College & Rajiv Gandhi Government General hospital Chennai, India, Midas Multispeciality Hospital Pvt. Ltd. Maharashtra, Institute of Digestive and Liver Disease Dispur Hospitals, Assam, Dayanand Medical college and Hospital, Punjab, Peerless Hospitex Hospital and Research Centre Ltd. Kolkata, India

Study timelines

Date when funding contract was signed

Planned:31/03/2021

Actual:01/09/2017

Study start date

Planned:30/11/2021

Actual:29/12/2021

Data analysis start date

Planned:31/10/2023

Date of final study report

Planned:28/02/2024

Actual:04/10/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable