The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.
Study Type
OBSERVATIONAL
Enrollment
137
No intervention or treatment will be administered as part of this study. Data available per routine clinical practice at clinic visits as well as directly from participant using a smartphone/tablet application will be collected.
Tokyo Medical and Dental University Hospital
Bunkyō City, Japan
Percentage of Participants With a Rectal Bleeding Score of 0 or 1
The rectal bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 indicates 'No blood seen' and 1 indicates 'Streaks of blood with stool less than half the time'.
Time frame: Up to Week 8
Percentage of Participants With a Stool Frequency Score of 0 or 1
The stool bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 will indicate 'Normal number of stools' and 1 will indicate '1 to 2 stools more than normal'.
Time frame: Up to Week 8
Change From Baseline in Rectal Bleeding Score Through Week 8
Change from baseline in rectal bleeding score through Week 8 will be reported.
Time frame: Baseline, Up to Week 8
Change from Baseline in Stool Frequency Score Through Week 8
Change from baseline in stool frequency score through Week 8 will be reported.
Time frame: Baseline, Up to Week 8
Percentage of Participants with a Reduction in Rectal Bleeding Score of Greater than or Equal to (>=) 1 From Baseline
Percentage of participants with a reduction in rectal bleeding score of \>= 1 from baseline through Week 8 will be reported.
Time frame: Up to Week 8
Percentage of Participants with Reduction in Stool Frequency Score of >= 1 From Baseline
Percentage of participants with a reduction in stool frequency score of \>= 1 from baseline through Week 8 will be reported.
Time frame: Up to Week 8
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Juntendo University Hospital
Bunkyō City, Japan
Chiba University Hospital
Chiba, Japan
Toho University Sakura Medical Center
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
Fukuoka University Hospital
Fukuoka, Japan
Hamamatsu University Hospital
Hamamatsu, Japan
Shimane University Hospital
Izumo, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, Japan
Saitama Medical University Saitama Medical Center
Kawagoe, Japan
...and 13 more locations
Change from Baseline in Calculated Partial Mayo Score at Week 8 and Week 16 or Week 20
The partial Mayo (pMayo) is a composite score to indicate ulcerative colitis status without the requirement for endoscopy. It records participant-reported stool frequency over three days relative to normal on a 0-3 subscale (stool frequency, rectal bleeding, and physician global assessment of disease severity) each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.
Time frame: Baseline, Week 8 and Week 16 or Week 20
Change from Baseline in Rectal Bleeding Score at Week 16 or Week 20
Change from baseline in rectal bleeding score Week 16 or Week 20 will be reported.
Time frame: Baseline, Week 16 or Week 20
Change from Baseline in Stool Frequency Score at Week 16 or Week 20
Change from baseline in stool frequency score at Week 16 or Week 20 will be reported.
Time frame: Baseline, Week 16 or Week 20
Change from Baseline in Abdominal Pain Through Week 8
Change from baseline in abdominal pain through Week 8 will be reported. Abdominal Pain will be evaluated based on numeric rating scale (NRS) ranging from 0 to 10 with lower score of 0 indicating 'no pain', score of 5 indicating 'moderate pain' and higher score of 10 indicating 'worst pain'. The abdominal pain score represents the most severe pain of the day.
Time frame: Baseline, Up to Week 8
Percentage of Participants with Presence of Nocturnal Diarrhea
Percentage of participants with presence of nocturnal diarrhea will be reported. Nocturnal Diarrhea will be evaluated based on 'Yes/No' questionnaire, completed by participants using a smartphone/tablet-based application.
Time frame: Up to Week 8
Percentage of Participants with Presence of Tenesmus
Percentage of participants with presence of tenesmus will be reported. Tenesmus will be evaluated based on 'Yes/No' questionnaire, completed by participants using a smartphone/tablet-based application.
Time frame: Up to Week 8
Percentage of Participants with Perceived Improvement in Ulcerative Colitis (UC)
Percentage of participants with perceived improvement in UC will be reported. Perceived Improvement in UC will be evaluated based on NRS ranging from 0 to 10 with lower score of 0 indicating 'completely better (no UC symptoms)', score of 5 indicating 'starting condition (condition immediately before the induction of ustekinumab)' and higher score of 10 indicating 'poor condition (lots of UC symptoms).' Improvement is shown by recording a number less than 5 and worsening by recording a number greater than 5.
Time frame: Up to Week 8