Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.
This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-650 | Experimental | Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30. Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-650 | Drug | TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Achieved PCDAI Response | Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| PCDAI Score | Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Toshifumi Hibi, MD | Kitasato University Kitasato Institute Hospital | Study Director |
| Kazuoki Kondo, MD | Mitsubihsi Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Chūbu | Japan | ||||
| Investigational site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30114224 | Result | Tajiri H, Motoya S, Kinjo F, Maemoto A, Matsumoto T, Sato N, Yamada H, Nagano M, Susuta Y, Ozaki K, Kondo K, Hibi T. Infliximab for pediatric patients with Crohn's disease: A Phase 3, open-label, uncontrolled, multicenter trial in Japan. PLoS One. 2018 Aug 16;13(8):e0201956. doi: 10.1371/journal.pone.0201956. eCollection 2018. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TA-650 | This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg. TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen. For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen. If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Period (Week 0 to 14) |
| |||||||||||||
| Maintenance Period (Week 14 to 54) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TA-650 | This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg. TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen. For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen. If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients Who Achieved PCDAI Response | Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | 2 patients were discontinued because of an adverse event and a lack of efficacy respectively. | Posted | Number | percentage of participants | Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TA-650 | This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg. TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen. For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen. If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
Not provided
| ID | Term |
|---|---|
| C536215 | Pediatric Crohn's disease |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Change From Baseline of PCDAI Score | Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54 |
| Percent of Patients Who Achieved PCDAI-Based Remission Rate. | Crohn's Disease Activity Index(PCDAI)-based remission was defined as a case where PCDAI on the evaluation day was decreased to not more than 10. Patients who satisfied the criterion for PCDAI response at least once in the evaluation at Week 2, 6 and 10 were defined as responders at Week 10. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54 |
| Serum TA-650 Concentration | Median, Min and Max of serum TA-650 concentration at each evaluation point after dose of 5 mg/kg TA-650. | After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration. |
| The Percent of the Patients Who Experienced an Adverse Event | Until the last time point during the period from administration of the study drug to Week 54 |
| Hokkaido |
| Japan |
| Investigational site | Hokuriku | Japan |
| Investigational site | Kanto | Japan |
| Investigational site | Kinki | Japan |
| Investigational site | Kyusyu | Japan |
| Investigational site | Tōhoku | Japan |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
This group represents patients who received at least one dose of TA-650 5 mg/kg or 10 mg/kg.
TA-650 was intravenously infused at a dose of 5 mg/kg at Week 0, 2, 6 as an induction regimen.
For patients who met the responder criteria at Week 10, TA-650 was administered at 8-week intervals thereafter until week 46 as a maintenance regimen.
If the the criteria for a dose-increasing are met at Week 14, 22, 30, 38 or 46, TA-650 was administered at a dose of 10 mg/kg.
|
|
| Secondary | PCDAI Score | Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | 2 patients were discontinued because of an adverse event and a lack of efficacy respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54 |
|
|
|
| Secondary | Change From Baseline of PCDAI Score | Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | 2 patients were discontinued because of an adverse event and a lack of efficacy respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54 |
|
|
|
| Secondary | Percent of Patients Who Achieved PCDAI-Based Remission Rate. | Crohn's Disease Activity Index(PCDAI)-based remission was defined as a case where PCDAI on the evaluation day was decreased to not more than 10. Patients who satisfied the criterion for PCDAI response at least once in the evaluation at Week 2, 6 and 10 were defined as responders at Week 10. PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10). | 2 patients were discontinued because of an adverse event and a lack of efficacy respectively. | Posted | Number | percentage of participants | Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54 |
|
|
|
| Secondary | Serum TA-650 Concentration | Median, Min and Max of serum TA-650 concentration at each evaluation point after dose of 5 mg/kg TA-650. | This table does not include the data after an increased dose of 10 mg/kg. In the case of missing examination values or the case where measurement was impossible due to problems with test samples, the relevant measurement result was treated as a missing value. | Posted | Median | Full Range | μg/mL | After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration. |
|
|
|
| Secondary | The Percent of the Patients Who Experienced an Adverse Event | The analysis population is overall patients receiving at least one dose of TA-650 5 mg/kg or 10 mg/kg. | Posted | Number | percentage of participants | Until the last time point during the period from administration of the study drug to Week 54 |
|
|
|
| 2 |
| 14 |
| 14 |
| 14 |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atrioventricular dissociation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Antinuclear antibody increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Double stranded DNA antibody positive | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
Not provided
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Week 6 |
|
|
| Week 10 |
|
|
| Week 14 |
|
|
| Week 18 |
|
|
| Week 22 |
|
|
| Week 26 |
|
|
| Week 30 |
|
|
| Week 34 |
|
|
| Week 38 |
|
|
| Week 42 |
|
|
| Week 46 |
|
|
| Week 50 |
|
|
| Week 54 |
|
|
| The last time point |
|
|
|
| Week 10 |
|
|
| Week 14 |
|
|
| Week 18 |
|
|
| Week 22 |
|
|
| Week 26 |
|
|
| Week 30 |
|
|
| Week 34 |
|
|
| Week 38 |
|
|
| Week 42 |
|
|
| Week 46 |
|
|
| Week 50 |
|
|
| Week 54 |
|
|
| The last time point |
|
|
|
| Week 10 |
|
|
| Week 14 |
|
|
| Week 18 |
|
|
| Week 22 |
|
|
| Week 26 |
|
|
| Week 30 |
|
|
| Week 34 |
|
|
| Week 38 |
|
|
| Week 42 |
|
|
| Week 46 |
|
|
| Week 50 |
|
|
| Week 54 |
|
|
| The last time point |
|
|
|
| Week 2, before dose |
|
|
| Week 6, before dose |
|
|
| Week 10 |
|
|
| Week 14, before dose |
|
|
| Week 18 |
|
|
| Week 22, before dose |
|
|
| Week 22, 1 hr after end of dose |
|
|
| Week 26 |
|
|
| Week 30, before dose |
|
|
| Week 34 |
|
|
| Week 38, before dose |
|
|
| Week 42 |
|
|
| Week 46, before dose |
|
|
| Week 46, 1 hr after end of dose |
|
|
| Week 50 |
|
|
| Week 54 |
|
|