EFFICACY AND SAFETY OF S.C. INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB

NCT05719389 | Unknown DMC

• 1 other identifier: BIO BETTER SWITCH
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Phase-IV, national, multicentric, non-randomized, observational real-life study. The goal of this stud is to investigate the patient's benefits in terms of quality of life and work ability resulting from the switch from infliximab i.v. to s.c. in patients with gastroenterological or rheumatological indication at month 12.Patients who are eligible but were switched before the inclusion in this study will also be enrolled, and the data already collected according to clinical practice and consistent with the study outcome measures will be used retrospectively. All patients will be followed up according to the standard of care of each participating center. The main questions it aims to answer are:

• Job type and need for any authorization to go to the hospital to receive the study drug
• Distance and duration of the travel home-hospital
• Mode of travel home-hospital
• Need for a caregiver to be present
• Time spent at hospital
• Patient's preference for the way of study drug administration expressed on a 10-grades VAS scale. The study period for observation will be 12 months from the date of switch. At week 0, month 2, 6 and 12 from the date of the switch, clinical activity, safety data and biomarker levels will be collected. For those patients who have had an endoscopic evaluation of the disease within 2 months of inclusion and repeat the endoscopic evaluation at 12 months ± 8 weeks, endoscopic data will also be collected (valid only in the presence of IBD). In those centers where a blood sample to analyze the minimum levels and anti-drug antibodies of infliximab has been collected and/or stored within 2 months prior to the date of transition, the patient will be asked to give informed consent to the use of this sample and to provide a blood sample for the same analysis at week 0, month 2 and 12. These samples will be analyzed and compared to evaluate the immunogenicity of the drug. These analyzes will be centralized in one lab.

Conditions

Inflammatory Bowel Diseases; Rheumatologic Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with stable or improved from baseline WPAI and SF-36 scores at month 12 s.c. in patients with gastroenterological or rheumatological indication at month 12.

  Proportion of patients with stable or improved from baseline WPAI and SF-36 scores at month 12 s.c. in patients with gastroenterological or rheumatological indication at month 12.

  12 months

Secondary Outcomes (3)

• Proportion of patients with normal or improved clinical scores at month 2, 6, and 12

  12 months

• Number, severity, and type of adverse events/ seriuos adverse events through month 12

  12 months

• f) Difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching

  12 months

Interventions

CT-P13 DRUG

CT-P13 is a biosimilar of infliximab approved by EMA since 2015, and it is administered intravenously (i.v.) at a standard dose of 5 mg/kg at week 0, 2, 6 and then every 8 weeks, although the scheduled maintenance regimen can be optimized by administering the drug every 4-6 weeks or increasing the dose up to 10 mg/kg2.The safety profile of CT-P13 SC was comparable to that of CT-P13 i.v.; There were also fewer patients with positive anti-drug antibodies with CT-P13 SC than with CT-P13 i.v.3 At the moment, no data are available on the effectiveness, safety and immunogenicity in a real-world population of patients who have been switched from i.v. to s.c. infliximab.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

250 patients with any indication will be enrolled. Since no previous data are available from the literature, this is a number which is considered reasonable to get adequate magnitude to support the validity of the expected data for the primary outcome. At least 10 hospitals across Italy will be involved, where IBD patients and patients with rheumatological disease are regularly followed-up and treated for their condition. The enrollment will be competitive, although all measures will be taken to allow adequate balance in the number of patients enrolled in each center, and in the number of patients with gastroenterological or rheumatological conditions.

You may qualify if:

• Male or female patient of ≥18 years age and no upper age limit
• Patients with confirmed diagnosis of at least one of the following conditions: Crohn's disease; ulcerative colitis; rheumatoid arthritis4 (2010 ACR/EULAR criteria); ankylosing spondylitis (according to the ASAS modification of the Berlin algorithm for diagnosing ankylosing spondylitis)5; psoriatic arthritis (CASPAR criteria)6.
• Treatment with infliximab is according to local approved label
• Full ability to understand the study procedures and to sign an informed consent form

You may not qualify if:

• a. Known intolerance/allergy/reaction to infliximab or any excipient included in the s.c. infliximab formulation
• Non confirmed diagnosis of IBD (unclassified IBD) or not classifiable as having RA or AxSpA or PsA according to the respective criteria
• Cardiac insufficiency grade IV according to the NYHA scale

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Collagen Diseases

Interventions

CT-P13

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Silvio Danese

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvio Danese

CONTACT

0226432069; ibd.trials@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GASTROENTEROLOGIST

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 9, 2023
• Study Start: September 14, 2022
• Primary Completion: October 20, 2023
• Study Completion: April 20, 2025
• Last Updated: February 9, 2023

Record last verified: 2023-01

Locations

IT (1)