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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275PSO3009 | Other Identifier | Janssen Biotech, Inc |
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The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.
In this study, a proportion of subjects will receive study agent at its recommended dose and interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than 100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will have the opportunity to receive study agent less frequently during the randomization period depending on the subject's response. The study consists of a 4-week screening period; a 28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104; a 12 week post-treatment period; and a 20-week safety follow-up. Participants will be randomized for the double blind period into one of two study groups. Group 1 participants will receive an injection of the study medication at a 12 week dosing interval. Group 2 participants will undergo a placebo withdrawal and may receive study agents at an extended interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups 1 and 2 will receive placebo as necessary to maintain the blind.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Approved q12w maintenance regimen | Experimental | Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind |
|
| Group 2: Subject-tailored fixed-interval maintenance regimen | Experimental | Subjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab 45 mg | Drug | Form = Injection, route = subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) | Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe. | Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe. |
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Key Eligibility Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Biotech, Inc. Clinical Trial | Janssen Biotech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29559344 | Derived | Loesche MA, Farahi K, Capone K, Fakharzadeh S, Blauvelt A, Duffin KC, DePrimo SE, Munoz-Elias EJ, Brodmerkel C, Dasgupta B, Chevrier M, Smith K, Horwinski J, Tyldsley A, Grice EA. Longitudinal Study of the Psoriasis-Associated Skin Microbiome during Therapy with Ustekinumab in a Randomized Phase 3b Clinical Trial. J Invest Dermatol. 2018 Sep;138(9):1973-1981. doi: 10.1016/j.jid.2018.03.1501. Epub 2018 Mar 17. | |
| 28600818 |
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During this study, two subjects were transferred between sites and counted twice. Hence, a total of 478 subjects were enrolled in this trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ustekinumab 45 mg/Ustekinumab 90 mg | Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label |
|
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| Ustekinumab 90 mg | Drug | Form = Injection, route = subcutaneous |
|
| Placebo | Drug | Form = Injection, route = subcutaneous |
|
| Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 |
| The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline. | Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) |
| The Percentage of Participants With a PASI 75 Response Over Time | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline. | Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 |
| Bakersfield |
| California |
| United States |
| Irvine | California | United States |
| Los Angeles | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Santa Monica | California | United States |
| Denver | Colorado | United States |
| Bridgeport | Connecticut | United States |
| Coral Gables | Florida | United States |
| Saint Augustine | Florida | United States |
| Tampa | Florida | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Plainfield | Indiana | United States |
| Louisville | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Boston | Massachusetts | United States |
| Troy | Michigan | United States |
| Fridley | Minnesota | United States |
| St Louis | Missouri | United States |
| Henderson | Nevada | United States |
| Lebanon | New Hampshire | United States |
| East Windsor | New Jersey | United States |
| New York | New York | United States |
| The Bronx | New York | United States |
| Williamsville | New York | United States |
| Gahanna | Ohio | United States |
| Norman | Oklahoma | United States |
| Portland | Oregon | United States |
| Pittsburgh | Pennsylvania | United States |
| Yardley | Pennsylvania | United States |
| Johnston | Rhode Island | United States |
| Nashville | Tennessee | United States |
| Arlington | Texas | United States |
| Dallas | Texas | United States |
| Salt Lake City | Utah | United States |
| Norfolk | Virginia | United States |
| Spokane | Washington | United States |
| Clarksburg | West Virginia | United States |
| Derived |
| Blauvelt A, Ferris LK, Yamauchi PS, Qureshi A, Leonardi CL, Farahi K, Fakharzadeh S, Hsu MC, Li S, Chevrier M, Smith K, Goyal K, Chen Y, Munoz-Elias EJ, Callis Duffin K. Extension of ustekinumab maintenance dosing interval in moderate-to-severe psoriasis: results of a phase IIIb, randomized, double-blinded, active-controlled, multicentre study (PSTELLAR). Br J Dermatol. 2017 Dec;177(6):1552-1561. doi: 10.1111/bjd.15722. Epub 2017 Nov 16. |
| Group 1: Approved q12w Maintenance Regimen |
Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo. |
| FG002 | Group 2: Subject-tailored Fixed-interval Maintenance Regimen | Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind |
|
|
The "enrolled subject data set" was defined as all participants enrolled at Week 0 who received at least 1 dose of ustekinumab during the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ustekinumab 45 mg/Ustekinumab 90 mg | Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) | Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe. | The "subjects randomized at Week 28 data set" was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28. | Posted | Mean | 95% Confidence Interval | number of visits | Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time | Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe. | The Analysis population was "subjects randomized at Week 28 data set". 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively. | Posted | Number | percentage of participants | Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 |
| |||||||||||||||||||||||||||||||
| Secondary | The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline. | The "subjects randomized at Week 28 data set" was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28. | Posted | Mean | Standard Deviation | number of visits | Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]) |
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With a PASI 75 Response Over Time | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline. | The Analysis population was "subjects randomized at Week 28 data set". 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively. | Posted | Number | percentage of participants | Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112 |
|
Week 0 through Week 124
During this study, 5 pregnancies were reported in female participants in Group 2, and 2 pregnancies were reported in partners of male participants in Group 2.
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 | Ustekinumab 45 mg/Ustekinumab 90 mg | Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0. | 14 | 478 | 73 | 478 | ||
| EG001 | Group 1: Approved q12w Maintenance Regimen | Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo. | 7 | 76 | 39 | 76 | ||
| EG002 | Group 2: Subject-tailored Fixed-interval Maintenance Regimen | Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo. | 21 | 302 | 131 | 302 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 14.0 | Systematic Assessment | During this study, a total of 2 deaths were reported. 1 participant in Group 1 died of natural causes and reported as an SAE of Death, and 1 participant in Group 2 died as an outcome of Acute Myeloid Leukemia (AML) and reported as an SAE of AML. |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Appendicitis Perforated | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Spondylolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
| |
| Chronic Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Carotid Artery Occlusion | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Drug Withdrawal Convulsions | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Viith Nerve Paralysis | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Homicidal Ideation | Psychiatric disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Calculus Ureteric | Renal and urinary disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Vaginal Prolapse | Reproductive system and breast disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hernia Diaphragmatic Repair | Surgical and medical procedures | MedDRA Version 14.0 | Systematic Assessment |
| |
| Knee Arthroplasty | Surgical and medical procedures | MedDRA Version 14.0 | Systematic Assessment |
| |
| Spinal Laminectomy | Surgical and medical procedures | MedDRA Version 14.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | Janssen Biotech, Inc | ClinicalTrialDisclosure@its.jnj.com |
| 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 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Adverse Event |
|
| Death |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Pregnancy |
|
| Other |
|
Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo. |
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