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| ID | Type | Description | Link |
|---|---|---|---|
| C0743T12 | Other Identifier | Centocor | |
| 2006-003444-30 | EudraCT Number |
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The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.
This is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. Patients will be randomly (allocation to treatments available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups. The three treatment groups are: Group 1 - CNTO 1275 45 mg dosing at weeks 0 and 4, Group 2 - CNTO 1275 90 mg dosing at weeks 0 and 4, Group 3 - Etanercept 50 mg two times per week through week 12. The total duration for each participant will be up to 64 weeks (approximately 16 months). The active-controlled portion of the study is from Week 0 to Week 12 during which the efficacy and safety of etanercept and 2 dose levels of CNTO 1275 will be evaluated. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. Patients will receive 2 subcutaneous injections of CNTO 1275 (either 45 or 90 mg doses) or twice weekly injections of etanercept during the first twelve weeks of the study. Patients may receive two additional doses of CNTO 1275 (either 45 or 90 mg doses) up to week 44.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNTO 1275 45 mg | Experimental | Patients will receive CNTO 1275 45 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. |
|
| CNTO 1275 90 mg | Experimental | Patients will receive CNTO 1275 90 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment. |
|
| Etanercept 50 mg | Active Comparator | Patients will receive Etanercept 50 mg twice weekly through Week 12. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 1275 45 mg | Drug | Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 | Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12 | Number of participants achieving a physician global assessment (PGA) (0-5) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trial of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe). | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739254 | Derived | Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. | |
| 20071701 | Derived |
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903 partcipants received either ustekinumab (CNTO 1275) or etanercept at 67 sites in North America and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept (CP) | Controlled period (Week 0-12) - Etanercept group |
| FG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg group |
| FG002 | Ustekinumab 90 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 90 mg group |
| FG003 | Etanercept (After CP) | After Controlled period (Week 12- 64) - receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40 |
| FG004 | Ustekinumab 45 mg (After CP) | After Controlled period (Week 12-64) - receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40. |
| FG005 | Ustekinumab 90 mg (After CP) | After Controlled period (Week 12-64) - receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Controlled Period |
|
| ||||||||||||||||||
| After Controlled Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Etanercept | Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after. |
| 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 | Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 | Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0. | Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participants is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or has missing data at Week 12. | Posted | Number | Participants | Baseline and Week 12 |
|
Week 64
One participant in Etanercept (after controlled period [CP]), 1 participant in Ustekinumab 90 mg (after CP) and 3 participants stekinumab 45 mg (after CP) arms were discontinued study agent during the CP but had follow-up after CP and hence were included in the tables of frequent adverse events and serious adverse events after CP.
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 | Etanercept (CP) | Controlled period (Week 0-12) - Etanercept group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Compound Development Team Leader | Centocor Research & Development, Inc. | 1 215-793-7612 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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Not provided
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| CNTO 1275 90 mg | Drug | Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous |
|
| Etanercept 50 mg | Drug | Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous |
|
| Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12 | Number of participants achieving greater than or equal to 90 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). | Baseline and Week 12 |
| Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12) | The difference between the PASI score at Week 12 and that achieved after 12 weeks of retreatment. The PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). | Up to Week 52. Retreatment may occur anytime between Week 16 and Week 40 depending on time of losing PGA response. Hence end of 12 weeks of retreatment would be between Week 28 and Week 52, inclusive. |
| Griffiths CE, Strober BE, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N, Guzzo C, Xia Y, Zhou B, Li S, Dooley LT, Goldstein NH, Menter A; ACCEPT Study Group. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010 Jan 14;362(2):118-28. doi: 10.1056/NEJMoa0810652. |
| Lost to Follow-up |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 |
| Group II: Ustekinumab 45 mg |
Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after. |
| BG002 | Group III: Ustekinumab 90 mg | Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Group I: Etanercept |
Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after. |
| OG001 | Group II: Ustekinumab 45 mg | Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after. |
| OG002 | Group III: Ustekinumab 90 mg | Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after. |
|
|
|
| Secondary | Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12 | Number of participants achieving a physician global assessment (PGA) (0-5) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trial of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe). | Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had a missing PGA score. | Posted | Number | Participants | Week 12 |
|
|
|
|
| Secondary | Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12 | Number of participants achieving greater than or equal to 90 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). | Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. A participant is considered a non-responder if the participant has used any pre-specified prohibited medications, discontinued due to lack of efficacy, or had a missing Week 12 PASI score. | Posted | Number | Participants | Baseline and Week 12 |
|
|
|
|
| Secondary | Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12) | The difference between the PASI score at Week 12 and that achieved after 12 weeks of retreatment. The PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). | Participants who were randomized to ustekinumab, had a PGA score less than or equal to 2 at Week 12, and were retreated upon losing PGA response (PGA greater than or equal to 3). | Posted | Mean | Standard Error | Score on a scale | Up to Week 52. Retreatment may occur anytime between Week 16 and Week 40 depending on time of losing PGA response. Hence end of 12 weeks of retreatment would be between Week 28 and Week 52, inclusive. |
|
|
|
| 4 |
| 347 |
| 154 |
| 347 |
| EG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg group | 4 | 209 | 85 | 209 |
| EG002 | Ustekinumab 90 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 90 mg group | 4 | 347 | 126 | 347 |
| EG003 | Etanercept (After CP) | After Controlled period (Week 12-64) - receiving etanercept at Weeks 0 -> prior to being treated with ustekinumab | 8 | 337 | 60 | 337 |
| EG004 | Etanercept -> Ustekinumab 90 mg (After CP) | After Controlled period (Week 12-64) - receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg upon becoming a nonresponder during Week 12 and Week 40. This group is a subpopulation of Etanercept (after CP). | 10 | 295 | 102 | 295 |
| EG005 | Ustekinumab 45 mg (After CP) | After Controlled period (Week 12-64) - receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40. | 13 | 204 | 85 | 204 |
| EG006 | Ustekinumab 90 mg (After CP) | After Controlled period (Week 12-64) - receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40. | 22 | 343 | 164 | 343 |
| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diverticulitis intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Uvulitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| HIV infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Haematoma infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Oral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Substance abuse | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Finger amputation | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Microangiopathy | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Cochran-Mantel-Haenszel (CMH) chi square |
The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).](streamdown:incomplete-link) |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel (CMH) chi square |
The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).](streamdown:incomplete-link) |
| <0.001 |
| 95 |
| No |
| Superiority or Other |