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

JRCT ID: jRCT1011220023

Registered date:29/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: IBD, Psoriasis, Palmoplantar pustulosis, Malignant tumors (Melanoma etc.), RA, Autoimmune diseases
• Date of first enrollment: 29/10/2022
• Target sample size: 300
• Study type: Observational

Outcome(s)

• Primary Outcome: The rate of anti-drug antibody (ADA) development

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Subjects whose medical care and prognostic information can be obtained from medical records

Exclude 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.

Related Information

• Primary Sponsor: Fukudo Masahide