Therapeutic Monitoring of Infliximab and Adalimumab

NCT06033469 | Unknown

• 1 other identifier: RC 01/17
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Anti tumor necrosis factor (TNF agents), particularly infliximab and adalimumab, changed the way chronic inflammatory bowel disease (IBD) refractory to conventional therapies is treated, including in pediatric patients. However, approximately 10-30% of patients do not respond to initial therapy and up to 50% lose response over time. Variability in response to therapy may be influenced by multiple interacting factors at different levels. Recent studies showed that measurement of serum infliximab concentrations during induction therapy predicts treatment effects at one year. Therefore, therapeutic monitoring of infliximab is proposed as a useful strategy to improve clinical outcomes and optimize healthcare resources. Most commercially available methods for infliximab quantification are based on the ELISA assay, which has an assay time of at least 8 hours. Recently, commercial point-of-care devices became available with assay times of less than one hour, enabling real-time therapeutic drug monitoring; however, validation of these devices in clinical settings and comparison with standard assays are still needed, particularly in pediatric patients. In addition, some studies suggest that loss of response in patients treated with anti-TNFs may be partly due to the emergence of specific anti-drug antibodies (AAFs). A limitation of the most widely used ELISA assays is the inability to quantify drug and AAF when they are simultaneously present. Recently, innovative ELISA assays have become available to overcome this problem. However, there is a lack of comparative studies between the classical and the specific method in terms of clinical response in pediatric patients. In patients who do not respond to infliximab, especially if they have high levels of AAF, guidelines call for the use of adalimumab. For this drug, the evidence in the literature regarding therapeutic monitoring of adalimumab concentrations and association with response in pediatric patients is still very preliminary. This study, carried out in in pediatric patients with IBD, aims to:

1. 1.validate the "point of care" infliximab assay by comparing it with reference ELISA assays;
2. 2.evaluate the correlation of infliximab and AAF levels, as measured by the innovative ELISA assays, with response to therapy, compared to traditional assays.
3. 3.evaluate the association between adalimumab and AAF levels and response to therapy

Conditions

Inflammatory Bowel Diseases

Keywords

Infliximab; Adalimumab; Inflammatory Bowel Diseases; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Infliximab concentration

  Assessed with the point-of-care assay and with the ELISA assay

  Through study completion, an average of 5 years

• Adalimumab concentration

  Assessed with ELISA assay

  Through study completion, an average of 5 years

• AAF concentration

  Assessed by the novel ELISA assays

  Through study completion, an average of 5 years

• Response to therapy assessed with validated score

  Assessed by Pediatric Crohn's disease activity index (PCDAI) and Pediatric UlcerativeColitis Activity Index (PUCAI). PCDAI ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10. PUCAI score ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10-35, moderate disease activity from 35-65, and severe disease activity above 65

  Through study completion, an average of 5 years

Study Arms (1)

IBD group

Pediatric patients with IBD

Drug: Infliximab; Drug: Adalimumab

Interventions

Infliximab DRUG

Pediatric patients with IBD suitable for treatment with infliximab

IBD group

Adalimumab DRUG

Pediatric patients with IBD suitable for treatment with adalimumab

IBD group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric subjects with IBD suitable for treatment with infliximab or adalimumab

You may qualify if:

• IBD subjects
• age between 0 and 17 years
• suitable for treatment with infliximab or adalimumab

You may not qualify if:

• Pediatric subjects with IBD not suitable for treatment with infliximab or adalimumab

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (3)

Ospedale Maggiore

Bologna, Italy

RECRUITING

Ospedale Ca' Foncello

Treviso, Italy

RECRUITING

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Infliximab; Adalimumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Gabriele Stocco, MSC

  IRCCS materno infantile Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuliana Decorti, MD

CONTACT

+390403785111; giuliana.decorti@burlo.trieste.it

Gabriele Stocco, MSC

CONTACT

+390403785111; gabriele.stocco@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: March 15, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 14, 2024

Record last verified: 2023-09

Locations

IT (3)