A prospective observational study to investigate real-world IMmunogenicity of theraPeutic Antibodies and to identify faCTors responsible for the interindividual variability

A prospective observational study to investigate real-world IMmunogenicity of theraPeutic Antibodies and to identify faCTors responsible for the interindividual variability - IMPACT study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1011220023

Enrollment

1000

Registered

2022-10-29

Start date

2022-10-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD, Psoriasis, Palmoplantar pustulosis, Malignant tumors (Melanoma etc.), RA, Autoimmune diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects whose medical care and prognostic information can be obtained from medical records

Exclusion criteria

Exclusion criteria: Subjects presenting with any of the following will be excluded from the study: 1. Subjects who requested non-participation in this study based on a published opt-out document. 2. Subjects who are participating in or interested in participating in other clinical trials during the study period. 3. Subjects who are judged as not suitable for participating in this study by treating physician.

Design outcomes

Primary

Measure	Time frame
The rate of anti-drug antibody (ADA) development	—

Secondary

Measure	Time frame
-The titer of ADA -The presence of neutralizing antibody (NAb) -The time to first development of ADA/NAb after start of treatment -Serum drug concentrations -Serum chemokine (CXCL12 etc.) protein levels -Duration of response -The incidence of infusion reactions -The incidence of genetic polymorphisms (CXCL12, FCGRT, HLA etc.)	—

Contacts

Public ContactMasahide Fukudo

Sapporo Medical University Hospital

fukudom@sapmed.ac.jp+81-11-688-9686

Outcome results