Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275DMY3001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The study did not meet the primary endpoint.
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The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active polymyositis (PM)/dermatomyositis (DM) despite receiving 1 or more standard-of-care treatments (for example, glucocorticoids and/or immunomodulators).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ustekinumab | Experimental | Participants will receive body weight-range based IV dosing of approximately 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by ustekinumab 90 milligram (mg) subcutaneously (SC) at Week 8 and every 8 Weeks (q8w) administrations through Week 72. At Week 24, participants will receive IV dosing of placebo. |
|
| Group 2: Placebo | Placebo Comparator | Participants will receive IV dosing of placebo at Week 0 followed by placebo SC administrations at Weeks 8,16 and 24. At Week 24, participants will receive body weight-range based IV dosing of approximately 6 mg/kg of ustekinumab, followed by ustekinumab 90 mg SC q8w administrations Week 32 through Week 72. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab 6 mg/kg | Drug | Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24 | Minimal improvement was defined as IMACS TIS greater than or equal to (>=) 20 in participants with polymyositis (PM)/dermatomyositis (DM). Criteria used the 6 IMACS core set measures: physician global activity (PhGA)(0-10), patient global activity (PtGA)(0-10), manual muscle testing-8 (MMT-8)(0-80), muscle enzymes (creatine kinase, Aldolase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase), extramuscular assessment of myositis disease activity assessment tool (MDAAT)(0-10), and health assessment questionnaire disability index (HAQ-DI)(0-3). Absolute percent change in each core set measure was calculated as final value minus baseline value divided by range*100. Total improvement score was calculated by sum of 6 core set improvement scores. Total improvement score ranged from 0 to 100 where higher scores indicated greater improvement. This was categorized into 3 categories (minimal [improvement >=20], moderate [improvement >=40] and major [improvement >=60]). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Functional Index-2 (FI-2) at Week 24 | Change from baseline in FI-2 at Week 24 was reported. The FI-2 was a functional outcome developed for participants with adult PM or DM to assess muscle endurance in 7 muscle groups (shoulder flexion [0-60], shoulder abduction [0-60], head lift [0-60], hip flexion [0-60], step test [0-60], heel lift [0-120], and toe lift [0-120]). Each muscle group was scored as the number of correctly performed repetitions with 60 or 120 maximal number of repetitions depending on muscle group. The FI-2 was performed unilaterally, preferably on the participant's dominant side for muscle groups of shoulder, hip, and step test. The FI-2 score ranged from 0-60 or 0-120 depending on the muscle group. Higher score indicated better muscle endurance. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical and Dental University Hospital | Bunkyō City | 113 8519 | Japan | |||
| Fukushima Medical University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37652554 | Derived | Kawahata K, Ishii T, Gono T, Tsuchiya Y, Ohashi H, Yoshizawa K, Zheng R, Ayabe M, Nishikawa K. Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group study of ustekinumab in Japanese patients with active polymyositis and dermatomyositis who have not adequately responded to one or more standard-of-care treatments. RMD Open. 2023 Aug;9(3):e003268. doi: 10.1136/rmdopen-2023-003268. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16. |
| FG001 | Ustekinumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (Prior to Week 24) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2021 | Jan 20, 2023 |
Not provided
Not provided
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Not provided
|
| Ustekinumab 90 mg | Drug | Participants will receive ustekinumab 90 mg SC at Week 8 and every 8 Weeks (q8w) through Week 72 in Group 1 and q8w Week 32 through Week 72 in Group 2. |
|
|
| Placebo IV | Drug | Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2. |
|
| Placebo SC | Drug | Participants will receive SC dosing of placebo at Weeks 8,16 and 24. |
|
| Baseline, Week 24 |
| Percentage of Participants Who Experienced Disease Worsening Up to Week 24 Based on Consensus Criteria for Worsening | Percentage of participants who experienced disease worsening up to Week 24 based on consensus criteria for worsening was reported. Criteria for disease worsening in a clinical trial were based on international consensus guideline developed by the IMACS. The worsening of disease was defined as 1 of the following criteria: Worsening of the Physician Global Activity by >=2 centimeter (cm) on a 10-cm visual analogue scale (VAS) and worsening of findings of MMT-8 by >= 20 percent (%) from baseline; worsening of MDAAT-global extramuscular organ disease activity (a composite of constitutional, cutaneous, skeletal, gastrointestinal, pulmonary, and cardiac activity) by >=2 cm on a 10-cm VAS from baseline; worsening of any 3 of 6 IMACS core set (PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-D) activity measures by >= 30% from baseline. | Up to Week 24 |
| Change From Baseline in Manual Muscle Testing (MMT)-8 Score at Week 24 | Change from baseline in MMT-8 score at Week 24 was reported. Manual Muscle Testing was a partially validated tool to assess muscle strength. MMT-8 total score ranged from 0-80, where maximal score was sum of scores from 8 muscle groups (Deltoid middle [left/right], Biceps brachii [left/right], Gluteus maximus [left/right], Gluteus medius [left/right], Quadriceps [left/right], Wrist extensors [left/right], Ankle dorsiflexors [left/right], Neck flexors [axial]) and each muscle group was scored on a 0 to 10-point scale. The sides (right or left) used for calculating the total score. Higher score indicated greater muscle strength, that is, less impairment of muscle. | Baseline, Week 24 |
| Change From Baseline in Physician Global Activity (PhGA) at Week 24 | Change from baseline in PhGA at Week 24 was reported. Physician Global Activity was a partially validated tool to measure the global evaluation by the physician of the participant's overall disease activity at the time of assessment using a 0-10 cm VAS, where 0 cm= no evidence of disease activity and 10 cm= extremely active or severe disease activity. Negative values indicated improvement from baseline. | Baseline, Week 24 |
| Change From Baseline in Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT) at Week 24 | Change from baseline in extramuscular assessment by MDAAT at Week 24 was reported. This validated tool measure the degree of disease activity of extramuscular organ systems and muscle on a 0-10 cm VAS. Extramuscular activity ranged between 0 and 10 via VAS where, 0 cm = absent and 10 cm = maximum disease activity. | Baseline, Week 24 |
| Change From Baseline in Muscle Enzyme Levels at Week 24 | Change from baseline in muscle enzyme levels (creatine kinase, lactate dehydrogenase) at Week 24 was reported. | Baseline, Week 24 |
| Fukushima |
| 960 1295 |
| Japan |
| Shinko Hospital | Hyōgo | 651-0072 | Japan |
| Tokai University Hospital | Isehara | 259-1193 | Japan |
| Kagoshima University Hospital | Kagoshima | 890-8544 | Japan |
| St Marianna University Hospital | Kanagawa | 216 8511 | Japan |
| National Hospital Organization Osaka Minami Medical Center | Kawachi-Nagano | 586 8521 | Japan |
| Hospital of the University of Occupational and Enviromental Health | Kitakyushu | 807-8555 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Kurashiki Central Hospital | Kurashiki | 710-8602 | Japan |
| Shinshu University Hospital | Matsumoto | 390-8621 | Japan |
| Minaminagano Medical Center Shinonoi General Hospital | Nagano | 388-8004 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| National Hospital Organization Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Niigata University Medical And Dental Hospital | Niigata | 951 8520 | Japan |
| Okayama City General Medical Center Okayama City Hospital | Okayama | 700-8557 | Japan |
| Saga University Hospital | Saga | 849-8501 | Japan |
| Kitasato University Hospital | Sagamihara | 252-0375 | Japan |
| Sakai City Medical Center | Sakai | 593-8304 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Tohoku Medical And Pharmaceutical University Hospital | Sendai | 983-8512 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga Gun | 321 0293 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Shinjuku Ku | 162 8655 | Japan |
| The Jikei University Hospital | Tokyo | 105 8471 | Japan |
| Nippon Medical School Hospital | Tokyo | 113 8603 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Fujita Health University Hospital | Toyoake | 470-1192 | Japan |
| Ehime University Hospital | Tōon | 791-0295 | Japan |
| University of Tsukuba Hospital | Tsukuba | 305 8576 | Japan |
| Yamaguchi University Hospital | Ube | 755-8505 | Japan |
| Yokohama Rosai Hospital | Yokohama | 222-0036 | Japan |
Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16.
| FG002 | Placebo to Ustekinumab | Participants who received placebo (matching to ustekinumab) intravenously (IV) at Week 0, placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16, then in order to gain benefit from this study participants received body weight-range based IV dose of ustekinumab 6 milligrams per kilograms (mg/kg) and placebo SC (to maintain blinding) at Week 24, followed by ustekinumab 90 milligrams (mg) SC q8w thereafter through Week 72. |
| FG003 | Ustekinumab Through End of Study (EOS) | Participants who received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0, ustekinumab 90 mg as SC injection at Weeks 8 and 16 then received placebo IV (to maintain blinding) and ustekinumab 90 mg SC at Week 24 and ustekinumab 90 mg SC q8w thereafter through Week 72. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Second Intervention (Week 24 to Week 72) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16. |
| BG001 | Ustekinumab | Participants received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0 followed by ustekinumab 90 mg as SC injection at Weeks 8 and 16. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Percentage of Participants Who Achieved Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24 | Minimal improvement was defined as IMACS TIS greater than or equal to (>=) 20 in participants with polymyositis (PM)/dermatomyositis (DM). Criteria used the 6 IMACS core set measures: physician global activity (PhGA)(0-10), patient global activity (PtGA)(0-10), manual muscle testing-8 (MMT-8)(0-80), muscle enzymes (creatine kinase, Aldolase, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase), extramuscular assessment of myositis disease activity assessment tool (MDAAT)(0-10), and health assessment questionnaire disability index (HAQ-DI)(0-3). Absolute percent change in each core set measure was calculated as final value minus baseline value divided by range*100. Total improvement score was calculated by sum of 6 core set improvement scores. Total improvement score ranged from 0 to 100 where higher scores indicated greater improvement. This was categorized into 3 categories (minimal [improvement >=20], moderate [improvement >=40] and major [improvement >=60]). | All randomized analysis set included all participants who were randomized in this study. | Posted | Number | Percentage of participants | Week 24 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Index-2 (FI-2) at Week 24 | Change from baseline in FI-2 at Week 24 was reported. The FI-2 was a functional outcome developed for participants with adult PM or DM to assess muscle endurance in 7 muscle groups (shoulder flexion [0-60], shoulder abduction [0-60], head lift [0-60], hip flexion [0-60], step test [0-60], heel lift [0-120], and toe lift [0-120]). Each muscle group was scored as the number of correctly performed repetitions with 60 or 120 maximal number of repetitions depending on muscle group. The FI-2 was performed unilaterally, preferably on the participant's dominant side for muscle groups of shoulder, hip, and step test. The FI-2 score ranged from 0-60 or 0-120 depending on the muscle group. Higher score indicated better muscle endurance. | All randomized analysis set included all participants who were randomized in this study. Here, 'n' (number analyzed) signifies participants who were evaluable for this outcome measure for given categories. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Disease Worsening Up to Week 24 Based on Consensus Criteria for Worsening | Percentage of participants who experienced disease worsening up to Week 24 based on consensus criteria for worsening was reported. Criteria for disease worsening in a clinical trial were based on international consensus guideline developed by the IMACS. The worsening of disease was defined as 1 of the following criteria: Worsening of the Physician Global Activity by >=2 centimeter (cm) on a 10-cm visual analogue scale (VAS) and worsening of findings of MMT-8 by >= 20 percent (%) from baseline; worsening of MDAAT-global extramuscular organ disease activity (a composite of constitutional, cutaneous, skeletal, gastrointestinal, pulmonary, and cardiac activity) by >=2 cm on a 10-cm VAS from baseline; worsening of any 3 of 6 IMACS core set (PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-D) activity measures by >= 30% from baseline. | All randomized analysis set included all participants who were randomized in this study. | Posted | Number | Percentage of participants | Up to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Manual Muscle Testing (MMT)-8 Score at Week 24 | Change from baseline in MMT-8 score at Week 24 was reported. Manual Muscle Testing was a partially validated tool to assess muscle strength. MMT-8 total score ranged from 0-80, where maximal score was sum of scores from 8 muscle groups (Deltoid middle [left/right], Biceps brachii [left/right], Gluteus maximus [left/right], Gluteus medius [left/right], Quadriceps [left/right], Wrist extensors [left/right], Ankle dorsiflexors [left/right], Neck flexors [axial]) and each muscle group was scored on a 0 to 10-point scale. The sides (right or left) used for calculating the total score. Higher score indicated greater muscle strength, that is, less impairment of muscle. | All randomized analysis set included all participants who were randomized in this study. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physician Global Activity (PhGA) at Week 24 | Change from baseline in PhGA at Week 24 was reported. Physician Global Activity was a partially validated tool to measure the global evaluation by the physician of the participant's overall disease activity at the time of assessment using a 0-10 cm VAS, where 0 cm= no evidence of disease activity and 10 cm= extremely active or severe disease activity. Negative values indicated improvement from baseline. | All randomized analysis set included all participants who were randomized in this study. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT) at Week 24 | Change from baseline in extramuscular assessment by MDAAT at Week 24 was reported. This validated tool measure the degree of disease activity of extramuscular organ systems and muscle on a 0-10 cm VAS. Extramuscular activity ranged between 0 and 10 via VAS where, 0 cm = absent and 10 cm = maximum disease activity. | All randomized analysis set included all participants who were randomized in this study. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Muscle Enzyme Levels at Week 24 | Change from baseline in muscle enzyme levels (creatine kinase, lactate dehydrogenase) at Week 24 was reported. | All randomized analysis set included all participants who were randomized in this study. Here, 'n' (number analyzed) signifies participants who were evaluable for this outcome measure for given categories. | Posted | Mean | Standard Deviation | Enzyme units per liter (Enzyme U/L) | Baseline, Week 24 |
|
|
Up to Week 88
The safety analysis set included all randomized participants who received at least 1 dose (partial or complete, intravenously [IV] or subcutaneously [SC]) of study agent.
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 | Placebo | Participants received placebo (matching to ustekinumab) intravenously (IV) at Week 0, then placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16. | 0 | 26 | 1 | 26 | 16 | 26 |
| EG001 | Placebo to Ustekinumab | Participants who received placebo (matching to ustekinumab) intravenously (IV) at Week 0, placebo subcutaneously (SC) every 8 weeks (q8w) at Weeks 8 and 16, then in order to gain benefit from this study participants received body weight-range based IV dose of ustekinumab 6 milligrams per kilograms (mg/kg) and placebo SC (to maintain blinding) at Week 24, followed by ustekinumab 90 milligrams (mg) SC q8w thereafter through Week 72. | 0 | 26 | 6 | 26 | 15 | 26 |
| EG002 | Ustekinumab Through End of Study (EOS) | Participants who received body weight-range based IV dose of ustekinumab 6 mg/kg at Week 0, ustekinumab 90 mg as SC injection at Weeks 8 and 16 then received placebo IV (to maintain blinding) and ustekinumab 90 mg SC at Week 24 and ustekinumab 90 mg SC q8w thereafter through Week 72. | 0 | 25 | 8 | 25 | 24 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumatosis Intestinalis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Neuroleptic Malignant Syndrome | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anxiety Disorder | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vaccination Site Reaction | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
This study was terminated early due to lack of efficacy found at Week 24.
If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRODUCT DEVELOPMENT PORTFOLIO LEADER | Janssen Pharmaceutical K.K. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2022 | Jan 20, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin 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
| Withdrawal by Subject |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|