Trial Details

Not Recruiting
Basic Information
Clinical ID c5089
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.
Trial URL Visit Original Page
Study Information
Study Results

NULL
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 -
Interventions Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINOProduct Name: RemsimaProduct Code: 42942019Pharmaceutical Form: Powder for solution for infusion
Participant Information
Sponsor UNIVERSITCATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
City NULL
Country/Region Italy
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