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The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-650 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-650 | Drug | (1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period | To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | Increased Dose Period (Week 0 to Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| CDAI at Each Evaluation Time Point in the Increased Dose Period | CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | Increased Dose Period (every 4 weeks for up to 40 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshifumi Hibi, Professor | Department of Internal Medicine, Keio University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Hokkaido | Japan | ||||
| Investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | TA-650 | Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal. Increased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period |
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| ||||||||||||||||||||||||
| Increased Dose Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TA-650 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Screening period: |
| 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 | Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period | To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | Posted | Median | 95% Confidence Interval | units on a scale | Increased Dose Period (Week 0 to Week 8) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entire Evaluation Period | Screening Period + Increased Dose Period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA/J ver. 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA/J ver. 13.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
|
| CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period | CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | Increased Dose Period (every 4 weeks for up to 40 weeks) |
| CDAI Change at Each Evaluation Time Point in the Increased Dose Period | To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | Increased Dose Period (every 4 weeks for up to 40 weeks) |
| Serum Concentration of TA-650 at Each Time Point | Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks |
| Antibody to TA-650 Determination | Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40) |
| Kansai |
| Japan |
| Investigational site | Kanto | Japan |
| Investigational site | Kyushu | Japan |
| Responder |
|
|
| Standard Deviation |
| years |
|
| Sex: Female, Male | Screening period: | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | CDAI at Each Evaluation Time Point in the Increased Dose Period | CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point. | Posted | Median | Full Range | units on a scale | Increased Dose Period (every 4 weeks for up to 40 weeks) |
|
|
|
| Secondary | CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period | CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Increased Dose Period (every 4 weeks for up to 40 weeks) |
|
|
|
| Secondary | CDAI Change at Each Evaluation Time Point in the Increased Dose Period | To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points. | One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point. | Posted | Median | Full Range | units on a scale | Increased Dose Period (every 4 weeks for up to 40 weeks) |
|
|
|
| Secondary | Serum Concentration of TA-650 at Each Time Point | Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point. | Posted | Median | Full Range | μg/mL | Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks |
|
|
|
| Secondary | Antibody to TA-650 Determination | Posted | Number | percentage of participants | Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40) |
|
|
|
| 9 |
| 45 |
| 37 |
| 45 |
| EG001 | Screening Period | 2 | 45 | 25 | 45 |
| EG002 | Increased Dose Period | 8 | 39 | 29 | 39 |
| Melaena | Gastrointestinal disorders | MedDRA/J ver. 13.0 |
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| Peritonitis | Gastrointestinal disorders | MedDRA/J ver. 13.0 |
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| Bronchitis | Infections and infestations | MedDRA/J ver. 13.0 |
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| Cytomegalovirus infection | Infections and infestations | MedDRA/J ver. 13.0 |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA/J ver. 13.0 |
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| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA/J ver. 13.0 |
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| Influenza | Infections and infestations | MedDRA/J ver. 13.0 |
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| Gastroenteritis | Infections and infestations | MedDRA/J ver. 13.0 |
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| Pharyngitis | Infections and infestations | MedDRA/J ver. 13.0 |
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| Bronchitis | Infections and infestations | MedDRA/J ver. 13.0 |
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| Folliculitis | Infections and infestations | MedDRA/J ver. 13.0 |
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| Otitis externa | Infections and infestations | MedDRA/J ver. 13.0 |
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| Otitis media | Infections and infestations | MedDRA/J ver. 13.0 |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA/J ver. 13.0 |
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| Anal fistula infection | Infections and infestations | MedDRA/J ver. 13.0 |
|
| DNA antibody positive | Investigations | MedDRA/J ver. 13.0 |
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| Blood urine present | Investigations | MedDRA/J ver. 13.0 |
|
| Liver function test abnormal | Investigations | MedDRA/J ver. 13.0 |
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| Protein urine present | Investigations | MedDRA/J ver. 13.0 |
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| Blood alkaline phosphatase increased | Investigations | MedDRA/J ver. 13.0 |
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| Chest X-ray abnormal | Investigations | MedDRA/J ver. 13.0 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 |
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| Headache | Nervous system disorders | MedDRA/J ver. 13.0 |
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| Dizziness | Nervous system disorders | MedDRA/J ver. 13.0 |
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| Somnolence | Nervous system disorders | MedDRA/J ver. 13.0 |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 |
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| Polymorphic light eruption | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 |
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| Pyrexia | General disorders | MedDRA/J ver. 13.0 |
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| Oedema peripheral | General disorders | MedDRA/J ver. 13.0 |
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| Hot flush | Vascular disorders | MedDRA/J ver. 13.0 |
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| Anaemia | Blood and lymphatic system disorders | MedDRA/J ver. 13.0 |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA/J ver. 13.0 |
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| Injury | Injury, poisoning and procedural complications | MedDRA/J ver. 13.0 |
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| Contusion | Injury, poisoning and procedural complications | MedDRA/J ver. 13.0 |
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| Periodontitis | Gastrointestinal disorders | MedDRA/J ver. 13.0 |
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| Renal mass | Renal and urinary disorders | MedDRA/J ver. 13.0 |
|
| Haematospermia | Reproductive system and breast disorders | MedDRA/J ver. 13.0 |
|
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| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 40 (the last time point) |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 40 (the last time point) |
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| Week 0 to Week 12 |
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| Week 0 to Week 16 |
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| Week 0 to Week 20 |
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| Week 0 to Week 24 |
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| Week 0 to Week 28 |
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| Week 0 to Week 32 |
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| Week 0 to Week 36 |
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| Week 0 to Week 40 |
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| Week 0 to 40(last measurable time point) |
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| SP, Week 4 |
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| SP, Week 8 |
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| SP, Week 12 |
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| SP, Week 16 |
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| Increased dose Period(IP), Week0 (pre-dose) |
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| IP, 1 hr after treatment end for week 0 |
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| IP, Week 4 |
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| IP, Week 8 |
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| IP, Week 12 |
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| IP, Week 16 (pre-dose) |
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| IP, 1hr after administration at week 16 |
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| IP, Week 20 |
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| IP, Week 24 |
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| IP, Week 28 |
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| IP, Week 32 |
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| IP, Week 36 |
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| IP, Week 40 |
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| Inconclusive |
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