Crohn's Disease
Conditions
Keywords
mild to moderate active Crohn's disease, affecting ileum, ileocecal region, ascending colon, score of 180-400 on the CDAI
Brief summary
The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.
Detailed description
A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn's Disease (CD) in Japan
Interventions
DRUGD9421-C capsule 3 mg
Patients randomised to D9421-C 9 mg will take 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.
DRUGMesalazine tablets
Patients randomised to Mesalazine 3 g will take 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.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* 15 years of age or older * Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation until the study completion or discontinuation * Ability to read, write and to fill a diary card and HRQL questionnaire Having mild to moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline
Exclusion criteria
* Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease) * Patient who need any concomitant treatment for CD that may affect the assessment for efficacy of the study drug * Patient who need any medication which is prohibited due to suspected influence to metabolism of the study drug * Patient who is judged to be inadequate to participate in this study from the safety point of view Patient with well-founded doubt about protocol violation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission After 8-week of Treatment | 8 Week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission After 4-week of Treatment | 4 Week | 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. |
| Change in Observed CDAI Scores From Baseline to Weeks 2 | 2 Week | 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. |
| Change in Observed CDAI Scores From Baseline to Weeks 4 | 4 Week | 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. |
| Change in Observed CDAI Scores From Baseline to Weeks 8 | 8 Week | 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. |
| Cumulative Remission Rate at Week 2 | 2 Week | 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. |
| Cumulative Remission Rate at Week 4 | 4 Week | 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. |
| Cumulative Remission Rate at Week 8 | 8 Week | 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. |
| Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2 | 2 Week | Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 70 points. |
| Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4 | 4 Week | Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 70 points. |
| Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8 | 8 Week | Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 70 points. |
| Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2 | 2 Week | Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 100 points. |
| Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4 | 4 Week | Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 100 points. |
| Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8 | 8 Week | Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 100 points. |
| Change in Total IBDQ Scores From Baseline to Weeks 2 | 2 Week | 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. |
| Change in Total IBDQ Scores From Baseline to Weeks 4 | 4 Week | 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. |
| Change in Total IBDQ Scores From Baseline to Weeks 8 | 8 Week | 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. |
| Remission After 2-week of Treatment | 2 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function | 2 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function | 4 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function | 8 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function | 10 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom | 2 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom | 4 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom | 8 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom | 10 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function | 2 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function | 4 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function | 8 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function | 10 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 2 - Social Function | 2 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 4 - Social Function | 4 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 8 - Social Function | 8 Week | 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. |
| Change in IBDQ Scores From Baseline to Weeks 10 - Social Function | 10 Week | 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. |
| Change in Total IBDQ Scores From Baseline to Weeks 10 | 10 Week | 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. |
Countries
Japan
Participant flow
Recruitment details
First patient enrolled on 08 February 2012. Last subject last visit on 08 September 2014.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 56 |
| 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. | 56 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Subject Decision | 2 | 7 |
Baseline characteristics
| Characteristic | D9421-C 9mg + Mesalazine Placebo | Mesalazine 3g + D9421-C Placebo | Total |
|---|---|---|---|
| Age, Continuous | 38.1 Years STANDARD_DEVIATION 13.43 | 35.8 Years STANDARD_DEVIATION 10.71 | 36.9 Years STANDARD_DEVIATION 12.15 |
| Age, Customized <30 Years | 19 Participants | 20 Participants | 39 Participants |
| Age, Customized >=30 Years | 37 Participants | 36 Participants | 73 Participants |
| Race/Ethnicity, Customized Asian | 56 Participants | 55 Participants | 111 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 19 Participants | 13 Participants | 32 Participants |
| Sex: Female, Male Male | 37 Participants | 43 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 56 | 16 / 56 |
| serious Total, serious adverse events | 3 / 56 | 1 / 56 |
Outcome results
Primary
Remission After 8-week of Treatment
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.
Time frame: 8 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Remission After 8-week of Treatment | 17 Participants |
| Mesalazine 3g + D9421-C Placebo | Remission After 8-week of Treatment | 14 Participants |
Comparison: The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.p-value: 0.52690% CI: [-8.49, 18.94]Chi-squared
Secondary
Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function | 6.9 Scores on a scale | Standard Error 1.08 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function | 3.6 Scores on a scale | Standard Error 0.98 |
90% CI: [0.9, 5.76]
Secondary
Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function | 8.0 Scores on a scale | Standard Error 1.28 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function | 1.3 Scores on a scale | Standard Error 1.34 |
90% CI: [3.56, 9.72]
Secondary
Change in IBDQ Scores From Baseline to Weeks 10 - Social Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Social Function | 2.4 Scores on a scale | Standard Error 0.63 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Social Function | 1.2 Scores on a scale | Standard Error 0.56 |
90% CI: [-0.15, 2.76]
Secondary
Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom | 3.8 Scores on a scale | Standard Error 0.64 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom | 1.2 Scores on a scale | Standard Error 0.62 |
90% CI: [1.15, 4.09]
Secondary
Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function | 6.1 Scores on a scale | Standard Error 0.77 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function | 2.7 Scores on a scale | Standard Error 0.82 |
90% CI: [1.49, 5.29]
Secondary
Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function | 5.1 Scores on a scale | Standard Error 1 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function | 1.3 Scores on a scale | Standard Error 1 |
90% CI: [1.44, 6.19]
Secondary
Change in IBDQ Scores From Baseline to Weeks 2 - Social Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Social Function | 1.9 Scores on a scale | Standard Error 0.45 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Social Function | 0.6 Scores on a scale | Standard Error 0.55 |
90% CI: [0.01, 2.43]
Secondary
Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom | 3.0 Scores on a scale | Standard Error 0.49 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom | 1.0 Scores on a scale | Standard Error 0.48 |
90% CI: [0.89, 3.17]
Secondary
Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function | 6.6 Scores on a scale | Standard Error 0.99 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function | 2.8 Scores on a scale | Standard Error 0.84 |
90% CI: [1.64, 5.97]
Secondary
Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function | 7.0 Scores on a scale | Standard Error 1.25 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function | 2.1 Scores on a scale | Standard Error 1.08 |
90% CI: [2.14, 7.65]
Secondary
Change in IBDQ Scores From Baseline to Weeks 4 - Social Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Social Function | 2.5 Scores on a scale | Standard Error 0.58 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Social Function | 0.7 Scores on a scale | Standard Error 0.56 |
90% CI: [0.42, 3.12]
Secondary
Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom | 3.3 Scores on a scale | Standard Error 0.57 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom | 1.3 Scores on a scale | Standard Error 0.47 |
90% CI: [0.73, 3.19]
Secondary
Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function | 6.5 Scores on a scale | Standard Error 1.04 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function | 2.4 Scores on a scale | Standard Error 1.11 |
90% CI: [1.58, 6.64]
Secondary
Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function | 5.9 Scores on a scale | Standard Error 1.18 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function | 1.6 Scores on a scale | Standard Error 1.31 |
90% CI: [1.4, 7.25]
Secondary
Change in IBDQ Scores From Baseline to Weeks 8 - Social Function
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Social Function | 2.3 Scores on a scale | Standard Error 0.57 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Social Function | 0.7 Scores on a scale | Standard Error 0.63 |
90% CI: [0.19, 3.04]
Secondary
Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom | 3.5 Scores on a scale | Standard Error 0.58 |
| Mesalazine 3g + D9421-C Placebo | Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom | 1.2 Scores on a scale | Standard Error 0.61 |
90% CI: [0.96, 3.76]
Secondary
Change in Observed CDAI Scores From Baseline to Weeks 2
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in Observed CDAI Scores From Baseline to Weeks 2 | -38.5 Scores on a scale | Standard Error 8.91 |
| Mesalazine 3g + D9421-C Placebo | Change in Observed CDAI Scores From Baseline to Weeks 2 | -15.7 Scores on a scale | Standard Error 7.66 |
p-value: 0.05890% CI: [-42.55, -3.09]Mixed Models Analysis
Secondary
Change in Observed CDAI Scores From Baseline to Weeks 4
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in Observed CDAI Scores From Baseline to Weeks 4 | -58.7 Scores on a scale | Standard Error 9.44 |
| Mesalazine 3g + D9421-C Placebo | Change in Observed CDAI Scores From Baseline to Weeks 4 | -28.7 Scores on a scale | Standard Error 7.29 |
p-value: 0.01490% CI: [-49.95, -9.96]Mixed Models Analysis
Secondary
Change in Observed CDAI Scores From Baseline to Weeks 8
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in Observed CDAI Scores From Baseline to Weeks 8 | -67.0 Scores on a scale | Standard Error 11.17 |
| Mesalazine 3g + D9421-C Placebo | Change in Observed CDAI Scores From Baseline to Weeks 8 | -45.7 Scores on a scale | Standard Error 9.11 |
p-value: 0.14490% CI: [-45.47, 2.74]Mixed Models Analysis
Secondary
Change in Total IBDQ Scores From Baseline to Weeks 10
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in Total IBDQ Scores From Baseline to Weeks 10 | 21.1 Scores on a scale | Standard Error 3.11 |
| Mesalazine 3g + D9421-C Placebo | Change in Total IBDQ Scores From Baseline to Weeks 10 | 7.1 Scores on a scale | Standard Error 2.96 |
90% CI: [6.9, 21.23]
Secondary
Change in Total IBDQ Scores From Baseline to Weeks 2
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in Total IBDQ Scores From Baseline to Weeks 2 | 16.2 Scores on a scale | Standard Error 2.3 |
| Mesalazine 3g + D9421-C Placebo | Change in Total IBDQ Scores From Baseline to Weeks 2 | 5.7 Scores on a scale | Standard Error 2.41 |
90% CI: [4.86, 16.14]
Secondary
Change in Total IBDQ Scores From Baseline to Weeks 4
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in Total IBDQ Scores From Baseline to Weeks 4 | 19.4 Scores on a scale | Standard Error 3.03 |
| Mesalazine 3g + D9421-C Placebo | Change in Total IBDQ Scores From Baseline to Weeks 4 | 6.8 Scores on a scale | Standard Error 2.44 |
90% CI: [6.07, 19.11]
Secondary
Change in Total IBDQ Scores From Baseline to Weeks 8
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Change in Total IBDQ Scores From Baseline to Weeks 8 | 18.3 Scores on a scale | Standard Error 2.93 |
| Mesalazine 3g + D9421-C Placebo | Change in Total IBDQ Scores From Baseline to Weeks 8 | 5.8 Scores on a scale | Standard Error 3.16 |
90% CI: [5.4, 19.72]
Secondary
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2
Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 100 points.
Time frame: 2 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2 | 14 Participants | 9.07 |
| Mesalazine 3g + D9421-C Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2 | 10 Participants | 7.46 |
90% CI: [-5.67, 19.71]
Secondary
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4
Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 100 points.
Time frame: 4 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4 | 19 Participants | 9.07 |
| Mesalazine 3g + D9421-C Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4 | 11 Participants | 7.46 |
90% CI: [0.5, 27.4]
Secondary
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8
Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 100 points.
Time frame: 8 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8 | 24 Participants | 9.07 |
| Mesalazine 3g + D9421-C Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8 | 17 Participants | 7.46 |
90% CI: [-2.44, 26.68]
Secondary
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2
Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 70 points.
Time frame: 2 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2 | 19 Participants | 9.07 |
| Mesalazine 3g + D9421-C Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2 | 11 Participants | 7.46 |
90% CI: [0.5, 27.4]
Secondary
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4
Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 70 points.
Time frame: 4 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4 | 22 Participants | 9.07 |
| Mesalazine 3g + D9421-C Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4 | 13 Participants | 7.46 |
90% CI: [1.66, 29.61]
Secondary
Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8
Clinical improvement is defined as CDAI score of \<=150 or a decrease in CDAI score from baseline of at least 70 points.
Time frame: 8 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8 | 27 Participants | 9.07 |
| Mesalazine 3g + D9421-C Placebo | Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8 | 18 Participants | 7.46 |
90% CI: [0.85, 30.29]
Secondary
Cumulative Remission Rate at Week 2
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.
Time frame: 2 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Cumulative Remission Rate at Week 2 | 12.5 Percentage of participants |
| Mesalazine 3g + D9421-C Placebo | Cumulative Remission Rate at Week 2 | 10.7 Percentage of participants |
Secondary
Cumulative Remission Rate at Week 4
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.
Time frame: 4 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Cumulative Remission Rate at Week 4 | 25.0 Percentage of participants |
| Mesalazine 3g + D9421-C Placebo | Cumulative Remission Rate at Week 4 | 17.9 Percentage of participants |
Secondary
Cumulative Remission Rate at Week 8
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.
Time frame: 8 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Cumulative Remission Rate at Week 8 | 37.5 Percentage of participants |
| Mesalazine 3g + D9421-C Placebo | Cumulative Remission Rate at Week 8 | 30.4 Percentage of participants |
Secondary
Remission After 2-week of Treatment
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.
Time frame: 2 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Remission After 2-week of Treatment | 7 Participants |
| Mesalazine 3g + D9421-C Placebo | Remission After 2-week of Treatment | 6 Participants |
p-value: 0.76890% CI: [-8.54, 12.15]Chi-squared
Secondary
Remission After 4-week of Treatment
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.
Time frame: 4 Week
Population: All randomised patients who take the investigational products at least once and have data in the treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9mg + Mesalazine Placebo | Remission After 4-week of Treatment | 12 Participants |
| Mesalazine 3g + D9421-C Placebo | Remission After 4-week of Treatment | 7 Participants |
p-value: 0.20890% CI: [-2.87, 20.58]Chi-squared