A prospective observational study to investigate real-world IMmunogenicity of theraPeutic Antibodies and to identify faCTors responsible for the interindividual variability (IMPACT study)
Recruiting
- Conditions
- IBD, Psoriasis, Palmoplantar pustulosis, Malignant tumors (Melanoma etc.), RA, Autoimmune diseases
- Registration Number
- jRCT1011220023
- Lead Sponsor
- Sapporo Medical University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Subjects whose medical care and prognostic information can be obtained from medical records
Exclusion Criteria
Subjects presenting with any of the following will be excluded from the study:
- Subjects who requested non-participation in this study based on a published opt-out document.
- Subjects who are participating in or interested in participating in other clinical trials during the study period.
- Subjects who are judged as not suitable for participating in this study by treating physician.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - The rate of anti-drug antibody (ADA) development
- Secondary Outcome Measures
Name Time Method Serum chemokine (CXCL12 etc.) protein levels Serum chemokine (CXCL12 etc.) protein levels
Duration of response Duration of response
The titer of ADA The titer of anti-drug antibodies (ADA)
The time to first development of ADA/NAb after start of treatment The time to first development of anti-drug antibodies (ADA) or neutralizing antibody (NAb) after start of treatment
The presence of neutralizing antibody (NAb) The presence of neutralizing antibody (NAb)
Serum drug concentrations Serum drug concentrations
The incidence of infusion reactions The incidence of infusion reactions
The incidence of genetic polymorphisms (CXCL12, FCGRT, HLA etc.) The incidence of genetic polymorphisms (CXCL12, FCGRT, HLA etc.)