Trial Details

Not Recruiting
Basic Information
Clinical ID c2708
Identifier EUCTR2016-002061-54-IT
Trial Title Switch between originator infliximab (Remicade) and biosimilar infliximab (Remsima) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases._Evaluation of immunogenicity and clinical response_ - Switch between originator infliximab (Remicade) and biosimilar infliximab (Remsima)
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Rheumatoid arthritis, seronegative spondylo arthritis,_Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0_Level: PT_Classification code 10002556_Term: Ankylosing spondylitis_System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders_ MedDRA version: 20.0_Level: PT_Classification code 10039073_Term: Rheumatoid arthritis_System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders_ MedDRA version: 20.0_Level: PT_Classification code 10011401_Term: Crohn's disease_System Organ Class: 10017947 - Gastrointestinal disorders_ MedDRA version: 20.0_Level: PT_Classification code 10075634_Term: Acute haemorrhagic ulcerative colitis_System Organ Class: 10017947 - Gastrointestinal disorders_;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Interventions Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 Pharmaceutical Form: Powder for solution for infusion
Participant Information
Sponsor UNIVERSITCATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
City -
Country/Region Italy
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 -