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The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.
Patients with plaque psoriasis or psoriatic arthritis:
Screening Period:
TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours.
Increased Dose Period:
If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.
Patients with pustular psoriasis or psoriatic erythroderma:
TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-650 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-650 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point. | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions. | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hideshi Torii, MD | Social Insurance Central General Hospital | Study Director |
| Kazuoki Kondo, MD | Mitsubihsi Tanabe Pharma Corporation | Study Director |
| Hidemi Nakagawa, MD | The Jikei University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Chugoku | Japan | ||||
| Investigational site |
Patients of Pustular Psoriasis and Psoriatic Erythroderma could directly receive doses of TA-650 10mg per 1kg not to go though screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | TA-650 | During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either "efficacy attenuated" or "efficacy maintained" at week 8 of the normal dose period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period |
|
| ||||||||||||||||||
| Increased Dose Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plaque Psoriasis | From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| BG001 | Psoriatic Arthritis |
| 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 | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point. | Posted | Number | percentage of participants | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
|
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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 | TA-650（Normal Dose Period）Overall | Overall(Plaque Psoriasis・Psoriatic Arthritis) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis | Musculoskeletal and connective tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations |
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 |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions. 0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
| Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | From 0 (best) to 100 (worst) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
| Assessment of Severity (Only for Patients With Pustular Psoriasis) | From 0 (best) to 17 (worst) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
| Chūbu |
| Japan |
| Investigational site | Hokkaido | Japan |
| Investigational site | Kanto | Japan |
| Investigational site | Kinki | Japan |
| Investigational site | Kyushu | Japan |
| Investigational site | Tōhoku | Japan |
|
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| BG002 | Pustular Psoriasis | From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| BG003 | Psoriatic Erythroderma | From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| OG001 | Plaque Psoriasis | From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| OG002 | Psoriatic Arthritis | From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| OG003 | Pustular Psoriasis | From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
| OG004 | Psoriatic Erythroderma | From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours. |
|
|
| Secondary | Psoriasis Area and Severity Index (PASI) Score | Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions. | Posted | Median | Full Range | units on a scale | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
|
|
|
| Secondary | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions. 0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe | Posted | Number | percentage of participants | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
|
|
|
| Secondary | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | From 0 (best) to 100 (worst) | Posted | Median | Full Range | mm | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
|
|
|
| Secondary | Assessment of Severity (Only for Patients With Pustular Psoriasis) | From 0 (best) to 17 (worst) | Posted | Mean | Full Range | units on a scale | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period |
|
|
|
| 0 |
| 46 |
| 24 |
| 46 |
| EG001 | TA-650（Normal Dose Period）Plaque Psoriasis | Plaque Psoriasis | 0 | 36 | 19 | 36 |
| EG002 | TA-650（Normal Dose Period）Psoriatic Arthritis | Psoriatic Arthritis | 0 | 10 | 5 | 10 |
| EG003 | TA-650（Dose Escalation Period）Overall | Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma) | 5 | 51 | 47 | 51 |
| EG004 | TA-650（Dose Escalation Period）Plaque Psoriasis | Plaque Psoriasis | 4 | 31 | 30 | 31 |
| EG005 | TA-650（Dose Escalation Period）Psoriatic Arthritis | Psoriatic Arthritis | 0 | 8 | 7 | 8 |
| EG006 | TA-650（Dose Escalation Period）Pustular Psoriasis | Pustular Psoriasis | 1 | 7 | 6 | 7 |
| EG007 | TA-650（Dose Escalation Period）Psoriatic Erythroderma | Psoriatic Erythroderma | 0 | 5 | 4 | 5 |
| EG008 | TA-650（Entire Evaluation Period）Plaque Psoriasis | Plaque Psoriasis | 4 | 36 | 34 | 36 |
| EG009 | TA-650（Entire Evaluation Period）Psoriatic Arthritis | Psoriatic Arthritis | 0 | 10 | 9 | 10 |
| Cholecystitis | Hepatobiliary disorders |
|
| Pyelonephritis | Infections and infestations |
|
| Bacterial pneumonia | Infections and infestations |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Conjunctivitis | Infections and infestations |
|
| Enteritis infectious | Infections and infestations |
|
| Folliculitis | Infections and infestations |
|
| Furuncle | Infections and infestations |
|
| Gastroenteritis | Infections and infestations |
|
| Gingivitis | Infections and infestations |
|
| Herpes zoster | Infections and infestations |
|
| Infection | Infections and infestations |
|
| Influenza | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Oral herpes | Infections and infestations |
|
| Pneumonia bacterial | Infections and infestations |
|
| Sinusitis | Infections and infestations |
|
| Upper respiratory tract infection | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Vaginitis bacterial | Infections and infestations |
|
| Vulvovaginal candidiasis | Infections and infestations |
|
| Vulvovaginitis trichomonal | Infections and infestations |
|
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders |
|
| Decreased appetite | Metabolism and nutrition disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Diabetes mellitus | Metabolism and nutrition disorders |
|
| Hypoglycaemia | Metabolism and nutrition disorders |
|
| Depressive symptom | Psychiatric disorders |
|
| Insomnia | Psychiatric disorders |
|
| Headache | Nervous system disorders |
|
| Post herpetic neuralgia | Nervous system disorders |
|
| Iridocyclitis | Eye disorders |
|
| Keratitis | Eye disorders |
|
| Deafness unilateral | Ear and labyrinth disorders |
|
| Sudden hearing loss | Ear and labyrinth disorders |
|
| Tinnitus | Ear and labyrinth disorders |
|
| Vertigo | Ear and labyrinth disorders |
|
| Palpitations | Cardiac disorders |
|
| Tachycardia | Cardiac disorders |
|
| Flushing | Vascular disorders |
|
| Hypertension | Vascular disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
|
| Chapped lips | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Dental caries | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Gastric ulcer | Gastrointestinal disorders |
|
| Haemorrhoids | Gastrointestinal disorders |
|
| Large intestine polyp | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Hepatitis | Hepatobiliary disorders |
|
| Diffuse alopecia | Skin and subcutaneous tissue disorders |
|
| Eczema | Skin and subcutaneous tissue disorders |
|
| Erythema | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Psoriasis | Skin and subcutaneous tissue disorders |
|
| Purpura | Skin and subcutaneous tissue disorders |
|
| Urticaria | Skin and subcutaneous tissue disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Trigger finger | Musculoskeletal and connective tissue disorders |
|
| Hypertonic bladder | Renal and urinary disorders |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders |
|
| Dysfunctional uterine bleeding | Reproductive system and breast disorders |
|
| Erectile dysfunction | Reproductive system and breast disorders |
|
| Feeling abnormal | General disorders |
|
| Feeling hot | General disorders |
|
| Malaise | General disorders |
|
| Pyrexia | General disorders |
|
| Alanine aminotransferase increased | Investigations |
|
| Aspartate aminotransferase increased | Investigations |
|
| Blood pressure decreased | Investigations |
|
| Blood pressure increased | Investigations |
|
| Blood urine present | Investigations |
|
| Double stranded DNA antibody positive | Investigations |
|
| Interleukin level increased | Investigations |
|
| Liver function test abnormal | Investigations |
|
| Oxygen saturation decreased | Investigations |
|
| Arthropod sting | Injury, poisoning and procedural complications |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Foot fracture | Injury, poisoning and procedural complications |
|
| Hand fracture | Injury, poisoning and procedural complications |
|
| Limb crushing injury | Injury, poisoning and procedural complications |
|
| Nail avulsion | Injury, poisoning and procedural complications |
|
| Procedural pain | Injury, poisoning and procedural complications |
|
| Wrist fracture | Injury, poisoning and procedural complications |
|
Not provided
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Week 4 (n=51,31,8,7,5) |
|
| Week 8 (n=50,31,8,6,5) |
|
| Week 12 (n=49,30,8,6,5) |
|
| Week 16 (n=48,29,8,6,5) |
|
| Week 20 (n=46,28,7,6,5) |
|
| Week 24 (n=45,27,7,6,5) |
|
| Week 28 (n=44,26,7,6,5) |
|
| Week 32 (n=44,26,7,6,5) |
|
| Week 36 (n=44,26,7,6,5) |
|
| Week 40 (n=43,26,7,5,5) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=30) |
|
| Week 16 (n=29) |
|
| Week 20 (n=28) |
|
| Week 24 (n=27) |
|
| Week 28 (n=26) |
|
| Week 32 (n=26) |
|
| Week 36 (n=26) |
|
| Week 40 (n=26) |
|
| Title | Measurements |
|---|
|
| Week 12 (n=8) |
|
| Week 16 (n=8) |
|
| Week 20 (n=7) |
|
| Week 24 (n=7) |
|
| Week 28 (n=7) |
|
| Week 32 (n=7) |
|
| Week 36 (n=7) |
|
| Week 40 (n=7) |
|
| Title | Measurements |
|---|
|
| Week 12 (n=6) |
|
| Week 16 (n=6) |
|
| Week 20 (n=6) |
|
| Week 24 (n=6) |
|
| Week 28 (n=6) |
|
| Week 32 (n=6) |
|
| Week 36 (n=6) |
|
| Week 40 (n=5) |
|