Trial Details

Not Recruiting
Basic Information
Clinical ID c2606
Identifier EUCTR2019-003662-40-DE
Trial Title Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions MedDRA version: 20.1_Level: PT_Classification code 10021972_Term: Inflammatory bowel disease_System Organ Class: 10017947 - Gastrointestinal disorders_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Trade Name: Amgevita 40 mg Injektionsl鈭氣垈sung in einer Fertigspritze Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Amgevita 40 mg Injektionslsung im Fertigpen Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-
Participant Information
Sponsor Universitsklinikum Erlangen
City -
Country/Region Germany
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -