Trial Details

Not Recruiting
Basic Information
Clinical ID c5065
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
Trial URL Visit Original Page
Study Information
Study Results

NULL
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
Interventions Trade Name: Amgevita 40 mg Injektionsl?????ung in einer Fertigspritze Pharmaceutical Form: Solution for injection in pre-filled syringeINN or Proposed INN: ADALIMUMABCAS Number: 331731-18-1Concentration unit: mg milligram(s)Concent
Participant Information
Sponsor Universitsklinikum Erlangen
City NULL
Country/Region Germany
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement NULL
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE4
Time Information
Start Date NULL
Primary Completion Date NULL
Completion Date NULL