FKB327 Registry Study

JRCT ID: jRCT1031210582

Registered date:25/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis, Crohn's Disease, Psoriatic Arthritis
• Date of first enrollment: 01/01/2022
• Target sample size: 300
• Study type: Observational

Outcome(s)

Primary Outcome

For biologic-naive patients
The clinical remission rate at 24 weeks of FKB327 treatment by the partial Mayo score for patients with UC, the HBI for patients with CD. For patients with PsA, the functional remission rate at 24 weeks of FKB327 treatment by the HAQ.

For patients switched from adalimumab originator to FKB327
The clinical remission maintenance rate at 24 weeks from 0 week of FKB327 treatment which is switched from adalimumab originator to FKB327 by the partial Mayo score for patients with UC, the HBI for patients with CD. For patients with PsA, to assess the functional remission maintenance rate at 24 weeks from 0 week of FKB327 treatment which is switched from adalimumab originator to FKB327 by the HAQ.

Secondary Outcome

For biologic-naive patients
1)The clinical remission at 48 and 96 weeks of FKB327 treatment by the partial Mayo score for patients with
UC, the HBI for patients with CD. For patients with PsA, the functional remission rate at 48 and 96 weeks
of FKB327 treatment by the HAQ
2)Percentage of achievement in partial response at 24, 48, and 96 weeks of FKB327 treatment by the
partial Mayo score for patients with UC, the HBI for patients with CD. For patients with PsA, proportions of
patients achieving PASI75 and PASI90 at 24, 48 and 96 weeks
3)Sustained clinical remission rate at 24, 48 and 96 weeks by the partial Mayo score for patients with UC,
the HBI for patients with CD. For patients with PsA, sustained functional remission rate at 24, 48 and 96
weeks and the sustained proportions of patients achieving PASI 75 at 24, 48 and 96 weeks
4)Change of the injection-site pain at 4, 12, 24, 48, and 96 weeks by VAS
5)Patient's experience of drug use by questionnaire survey at 24 weeks

For patients switched from adalimumab originator to FKB327
1)The clinical remission maintenance at 48 and 96 weeks of FKB327 treatment by the partial Mayo score for
patients with UC, the HBI for patients with CD. For patients with PsA, percentage of the functional
remission maintenance rate through 48 and 96 weeks by the HAQ
2)Change of the injection-site pain at 0, 4, 12, 24, 48, and 96 weeks by VAS
3)Patient's experience of drug use by questionnaire survey at 0 and 24 weeks

For biologic-naive patients and patients switched from adalimumab originator to FKB327
1)Change in index (partial Mayo score/HBI/HAQ/PASI) at 0, 4, 12, 24, 48, and 96 weeks
2)Change of the injection-site pain at 4, 12, 24, 48, and 96 weeks by VAS
3)Change of the health status at 0, 24, 48, and 96 weeks by the EQ-5D-5L
4)Change of the productivity at 0, 24, 48, and 96 weeks by the WPAI
5)Global assessment by the CGIC and PGIC at 24, 48, and 96 weeks
6)AEs

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

For biologic-naive patients
1)Patients diagnosed with UC, CD/patients diagnosed with PsA by Classification criteria for psoriatic arthritis (CASPAR)
2)Patients with moderate disease activity/Severe disease activity (for patients with UC, CD)/Patients who have not achieved functional remission with existing treatment (for patients with PsA)
<partial Mayo score >= 6, based on findings over the past three days (for patients with UC)/HBI >= 8 , based on three clinical symptoms on the previous day and abdominal mass and complications at the time of the evaluation (for patients with CD)/HAQ > 0.5 (for patients with PsA) >
3)Biologic-naive patients
4)Male or female patients aged 16 years old or older (for patients with UC or CD) / Male or female patients 20 years of age or older (for patients with PsA)
5)Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. (However, the patient is limited to a person judged by the principal investigator or sub-investigator that he/she has capacity for adequate judgement.)

For patients switched from adalimumab originator to FKB327
1)Patients diagnosed with UC, CD/patients diagnosed with PsA by Classification criteria for psoriatic arthritis (CASPAR)
2)Patients who have been on adalimumab originator and in clinical remission* for at least 24 weeks at the point of 0 week. For PsA, patients who have been on adalimumab originator and in functional remission for at least 24 weeks at the point of 0 week.
<partial Mayo score <= 1, based on findings over the past three days (for patients with UC)/HBI <= 4, based on three clinical symptoms on the previous day and abdominal mass and complications at the time of the evaluation (for patients with CD)/HAQ <= 0.5 (for patients with PsA) >
3)Patients who are not using steroid drugs (for patients with UC, CD)
4)Male or female patients aged 16 years old or older (in patients with UC or CD) / Male or female patients 20 years of age or older (in patients with PsA)
5)Patients who have decided to switch from adalimumab originator to FKB327 due to medical reasons or patient preference
6)Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. (However, the patient is limited to a person judged by the principal investigator or sub-investigator that he/she has capacity for adequate judgement.)

Exclude criteria

For biologic-naive patients
1)Patients who fall under any of the warnings or contraindications listed in the package insert
2)Patients participating in other clinical studies. However, this does not apply observational studies if the lead principal investigator, principal investigator, and researchers, etc. at the study site conducting the study enrollment determine that the observational studies will not give an effect on the evaluation of the effectiveness and safety of this study.
3)Patients judged by the principal investigator or sub-investigator as being inappropriate for some reason

For patients switched from adalimumab originator to FKB327
1)Patients who fall under any of the warnings or contraindications listed in the package insert
2)Patients participating in other clinical studies. However, this does not apply observational studies if the lead principal investigator, principal investigator, and researchers, etc. at the study site conducting the study enrollment determine that the observational studies will not give an effect on the evaluation of the effectiveness and safety of this study.
3)Patients judged by the principal investigator or sub-investigator as being inappropriate for some reason

Related Information

• Primary Sponsor: Nozawa Kazutaka