Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Phase 1

• Conditions: Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: PTClassification code 10075634Term: Acute haemorrhagic ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002061-54-IT
• Lead Sponsor: IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-15
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1.age =18 years
2.diagnosis of
a.Rheumatoid Arthritis according to ACR criteria (1987 e 2010) OR
b.Sieronegative spondiloarthritis (Ankylosing Spondylitis or Sponsiloarthritis (Psoriasic Arthritis) according to ASAS criteria 2009 OR
c.Inflammatory Disease confirmed by endoscopic and histological criteria
3.Treatment with Infliximab RMP (Remicade®) for at least 6 months with stable dosage at least in the last two infusions.
4.Stable clinical response at the time of inclusion in the study (T-1) [stability is defined as reduction =30% of the disease activity scores in comparison with the start of treatment with Infliximab RMP (Remicade®)]
5.In case of concomitant therapy with immunosuppressive drugs (azatioprine/6 mercaptopurine, methotrexate o leflunomide), their dosage should be stable at least in the last 2 months.
6.In case of concomitant systemic therapy with steroids their dosage should be stable at least in the last 2 months and =7.5 mg/die of prednisone (or equivalent)
7.Any concomitant drug for diseases other than those under study should be at a stable dosage for at least 4 weeks before the study inclusion.

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

1.Active Infectious diseases
2.Severe comorbidities (known malignancy except for basal cell carcinoma, congestive heart failure NYHA grade III/IV, liver and/or hepatobiliary disease, renal disease)
3.Pregnancy or breast feeding
4.Any underlying condition which, in the opinion of the Investigator, might contrarindicate the switch to Remsima®

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified