Trial Outcomes & Findings for Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan (NCT NCT01514240)

NCT ID: NCT01514240

Last Updated: 2016-10-31

Results Overview

For the primary efficacy variable "Remission after 8 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 123 participants
• Primary outcome timeframe: 8 Week
• Results posted on: 2016-10-31

Participant Flow

First patient enrolled on 08 February 2012. Last subject last visit on 08 September 2014.

Out of 123 enrolled subjects, 112 subjects were randomised and 11 subjects were not randomised. The reasons of no randomisation were 'Eligibility criteria not met' (9 subjects) and 'Adverse event' (2 subjects).

Participant milestones

Measure	D9421-C 9mg + Mesalazine Placebo Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Overall Study STARTED	56	56
Overall Study COMPLETED	50	45
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Measure	D9421-C 9mg + Mesalazine Placebo Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Overall Study Adverse Event	4	4
Overall Study Subject Decision	2	7

Baseline Characteristics

Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

Baseline characteristics by cohort

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.	Total n=112 Participants Total of all reporting groups
Age, Continuous	38.1 Years STANDARD_DEVIATION 13.43 • n=5 Participants	35.8 Years STANDARD_DEVIATION 10.71 • n=7 Participants	36.9 Years STANDARD_DEVIATION 12.15 • n=5 Participants
Age, Customized <30 Years	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Customized >=30 Years	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	43 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Asian	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period

For the primary efficacy variable "Remission after 8 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Remission After 8-week of Treatment	17 Participants	14 Participants

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period

For the secondary efficacy variable "Remission after 2 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Remission After 2-week of Treatment	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period

For the secondary efficacy variable "Remission after 4 weeks of treatment", Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Remission After 4-week of Treatment	12 Participants	7 Participants

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.

Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.

Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=53 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=53 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in Observed CDAI Scores From Baseline to Weeks 2	-38.5 Scores on a scale Standard Error 8.91	-15.7 Scores on a scale Standard Error 7.66

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.

Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.

Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=55 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=50 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in Observed CDAI Scores From Baseline to Weeks 4	-58.7 Scores on a scale Standard Error 9.44	-28.7 Scores on a scale Standard Error 7.29

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.

Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.

Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=51 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in Observed CDAI Scores From Baseline to Weeks 8	-67.0 Scores on a scale Standard Error 11.17	-45.7 Scores on a scale Standard Error 9.11

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period

Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Cumulative Remission Rate at Week 2	12.5 Percentage of participants Interval 5.23 to 19.77	10.7 Percentage of participants Interval 3.92 to 17.51

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period

Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Cumulative Remission Rate at Week 4	25.0 Percentage of participants Interval 15.48 to 34.52	17.9 Percentage of participants Interval 9.44 to 26.28

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period

Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Cumulative Remission Rate at Week 8	37.5 Percentage of participants Interval 26.86 to 48.14	30.4 Percentage of participants Interval 20.25 to 40.46

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period.

Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2	19 Participants 9.07	11 Participants 7.46

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period.

Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4	22 Participants 9.07	13 Participants 7.46

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period.

Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8	27 Participants 9.07	18 Participants 7.46

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period.

Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2	14 Participants 9.07	10 Participants 7.46

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period.

Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4	19 Participants 9.07	11 Participants 7.46

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period.

Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8	24 Participants 9.07	17 Participants 7.46

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=54 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in Total IBDQ Scores From Baseline to Weeks 2	16.2 Scores on a scale Standard Error 2.30	5.7 Scores on a scale Standard Error 2.41

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=55 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=50 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in Total IBDQ Scores From Baseline to Weeks 4	19.4 Scores on a scale Standard Error 3.03	6.8 Scores on a scale Standard Error 2.44

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=51 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in Total IBDQ Scores From Baseline to Weeks 8	18.3 Scores on a scale Standard Error 2.93	5.8 Scores on a scale Standard Error 3.16

SECONDARY outcome

Timeframe: 10 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=50 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in Total IBDQ Scores From Baseline to Weeks 10	21.1 Scores on a scale Standard Error 3.11	7.1 Scores on a scale Standard Error 2.96

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=54 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function	6.1 Scores on a scale Standard Error 0.77	2.7 Scores on a scale Standard Error 0.82

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=55 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=50 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function	6.6 Scores on a scale Standard Error 0.99	2.8 Scores on a scale Standard Error 0.84

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=51 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function	6.5 Scores on a scale Standard Error 1.04	2.4 Scores on a scale Standard Error 1.11

SECONDARY outcome

Timeframe: 10 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=50 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function	6.9 Scores on a scale Standard Error 1.08	3.6 Scores on a scale Standard Error 0.98

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=54 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom	3.0 Scores on a scale Standard Error 0.49	1.0 Scores on a scale Standard Error 0.48

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=55 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=50 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom	3.3 Scores on a scale Standard Error 0.57	1.3 Scores on a scale Standard Error 0.47

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=51 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom	3.5 Scores on a scale Standard Error 0.58	1.2 Scores on a scale Standard Error 0.61

SECONDARY outcome

Timeframe: 10 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=50 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom	3.8 Scores on a scale Standard Error 0.64	1.2 Scores on a scale Standard Error 0.62

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=54 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function	5.1 Scores on a scale Standard Error 1.00	1.3 Scores on a scale Standard Error 1.00

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=55 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=50 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function	7.0 Scores on a scale Standard Error 1.25	2.1 Scores on a scale Standard Error 1.08

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=51 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function	5.9 Scores on a scale Standard Error 1.18	1.6 Scores on a scale Standard Error 1.31

SECONDARY outcome

Timeframe: 10 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=50 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function	8.0 Scores on a scale Standard Error 1.28	1.3 Scores on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: 2 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=56 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=54 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 2 - Social Function	1.9 Scores on a scale Standard Error 0.45	0.6 Scores on a scale Standard Error 0.55

SECONDARY outcome

Timeframe: 4 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=55 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=50 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 4 - Social Function	2.5 Scores on a scale Standard Error 0.58	0.7 Scores on a scale Standard Error 0.56

SECONDARY outcome

Timeframe: 8 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=51 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 8 - Social Function	2.3 Scores on a scale Standard Error 0.57	0.7 Scores on a scale Standard Error 0.63

SECONDARY outcome

Timeframe: 10 Week

Population: All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.

Outcome measures

Measure	D9421-C 9mg + Mesalazine Placebo n=50 Participants Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=45 Participants Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Change in IBDQ Scores From Baseline to Weeks 10 - Social Function	2.4 Scores on a scale Standard Error 0.63	1.2 Scores on a scale Standard Error 0.56

Adverse Events

D9421-C 9mg + Mesalazine Placebo

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Mesalazine 3g + D9421-C Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	D9421-C 9mg + Mesalazine Placebo n=56 participants at risk Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 participants at risk Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Gastrointestinal disorders Ileus	1.8% 1/56 • Number of events 1 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	1.8% 1/56 • Number of events 1 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	1.8% 1/56 • Number of events 1 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	0.00% 0/56 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)
Gastrointestinal disorders Pneumatosis intestinalis	1.8% 1/56 • Number of events 1 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	0.00% 0/56 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)

Other adverse events

Measure	D9421-C 9mg + Mesalazine Placebo n=56 participants at risk Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.	Mesalazine 3g + D9421-C Placebo n=56 participants at risk Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Gastrointestinal disorders Crohn's disease	1.8% 1/56 • Number of events 1 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	5.4% 3/56 • Number of events 3 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)
Gastrointestinal disorders Vomiting	5.4% 3/56 • Number of events 3 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	0.00% 0/56 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)
Infections and infestations Nasopharyngitis	10.7% 6/56 • Number of events 6 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	17.9% 10/56 • Number of events 10 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)
Infections and infestations Pharyngitis	0.00% 0/56 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	5.4% 3/56 • Number of events 3 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)
Nervous system disorders Headache	5.4% 3/56 • Number of events 4 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)	0.00% 0/56 • Adverse events collected from the date of signing of informed consent to Visit 6 or withdrawal visit (including the tapering period)

Additional Information

Masahiro Nii

Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan

Email: Masahiro.Nii@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
• Publication restrictions are in place

Restriction type: OTHER