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| ID | Type | Description | Link |
|---|---|---|---|
| C0379T04 | Other Identifier | Centocor |
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The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.
This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose. Patients will be monitored for the safety throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Placebo) | Placebo Comparator | Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg. |
|
| Group II (Ustekinumab 45 mg) | Experimental | Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. |
|
| Group III (Ustekinumab 90 mg) | Experimental | Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo. |
|
| Group IV | Experimental | Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. |
|
| Group V | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12 | Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
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| 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. | |
| 17287478 | Derived |
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320 participants from 45 sites in North America were randomized to receive either Ustekinumab or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (CP) | Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16. |
| FG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg. |
| FG002 | Ustekinumab 90 mg (CP) | Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg. |
| FG003 | Ustekinumab 45 mg Weekly for 4 Weeks (CP) | Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg. |
| FG004 | Ustekinumab 90 mg Weekly for 4 Weeks (CP) | Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Placebo | Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg. |
| BG001 | Group II: Ustekinumab 45 mg |
| 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 Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. 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. | Intent to treat. All participants randomized 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. | Posted | Number | Participants | Week 12 |
|
Week 36
Three participants received placebo by mistake at Week 0, including 1 participant who was not randomized into the study and 2 participants who were randomized to a CNTO 1275 group but received the incorrect study agent. 1 participant not randomized but treated with placebo was included in the placebo group for adverse events
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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 | Placebo (CP) | Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | Centocor Research & Development, Inc. | 1-800-457-6399 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo. |
|
|
| Placebo | Drug | Patients in the placebo group will receive placebo medication. |
|
| Week 12 |
| Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. 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. | Week 32 |
| Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. 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. | Week 28 |
| Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M; CNTO 1275 Psoriasis Study Group. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007 Feb 8;356(6):580-92. doi: 10.1056/NEJMoa062382. |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Other |
|
Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
| BG002 | Group III: Ustekinumab 90 mg | Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
| BG003 | Group IV: Ustekinumab 45 mg Weekly for 4 Weeks | Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
| BG004 | Group V: Ustekinumab 90 mg Weekly for 4 Weeks | Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Group II: Ustekinumab 45 mg | Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
| OG002 | Group III: Ustekinumab 90 mg | Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
| OG003 | Group IV: Ustekinumab 45 mg Weekly for 4 Weeks | Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
| OG004 | Group V: Ustekinumab 90 mg Weekly for 4 Weeks | Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo. |
|
|
|
| Secondary | Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12 | Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score. | 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. Other missing data were not imputed. | Posted | Number | Participants | Week 12 |
|
|
|
|
| Secondary | Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. 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. | 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. Other missing data were not imputed. | Posted | Number | Particpants | Week 32 |
|
|
|
| Secondary | Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. 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. | 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. Other missing data were not imputed. | Posted | Number | Participants | Week 28 |
|
|
|
| 1 |
| 67 |
| 36 |
| 67 |
| EG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg. | 3 | 63 | 38 | 63 |
| EG002 | Ustekinumab 90 mg (CP) | Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg. | 1 | 64 | 40 | 64 |
| EG003 | Ustekinumab 45 mg Weekly for 4 Weeks (CP) | Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg. | 2 | 63 | 31 | 63 |
| EG004 | Ustekinumab 90 mg Weekly for 4 Weeks (CP) | Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg. | 3 | 62 | 27 | 62 |
| EG005 | Placebo -> Ustekinumab 90 mg (After CP) | After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -> receiving ustekinumab 90 mg at Week 20. | 1 | 49 | 16 | 49 |
| EG006 | Ustekinumab 45 mg (After CP) | After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg. | 0 | 60 | 19 | 60 |
| EG007 | Ustekinumab 90 mg (After CP) | After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg. | 2 | 61 | 21 | 61 |
| EG008 | Ustekinumab 45 mg Weekly for 4 Weeks (After CP) | After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg. | 0 | 62 | 17 | 62 |
| EG009 | Ustekinumab 90 mg Weekly for 4 Weeks (After CP) | After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg. | 4 | 62 | 11 | 62 |
| Chest pain | Cardiac disorders | WHOART | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | WHOART | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | WHOART | Systematic Assessment |
|
| Hernia congenital | Congenital, familial and genetic disorders | WHOART | Systematic Assessment |
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| Hepatic enzymes increased | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Coronary artery disorder | Vascular disorders | WHOART | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | WHOART | Systematic Assessment |
|
| Uterine fibroid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
|
| Drug dependence | Psychiatric disorders | WHOART | Systematic Assessment |
|
| Psychosis | Psychiatric disorders | WHOART | Systematic Assessment |
|
| Infection viral | Infections and infestations | WHOART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Psoriasis aggravated | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Cerebral infarction | Vascular disorders | WHOART | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | WHOART | Systematic Assessment |
|
| Pain | Nervous system disorders | WHOART | Systematic Assessment |
|
| Headache | Nervous system disorders | WHOART | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Arthritis aggravated | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
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| Purpura | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
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| Rhinitis | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Upper resp tract infection | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | WHOART | 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 |
Stratified by baseline weight [≤ 90kg vs > 90 kg)].
| <0.001 |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel (CMH) chi square | <0.001 | 95 | No | Superiority or Other |
| Null Hypothesis: No difference between any ustekinumab group and placebo. | Cochran-Mantel-Haenszel (CMH) chi square | Stratified by baseline weight [≤ 90kg vs > 90 kg)]. | <0.001 | 95 | No | Superiority or Other |