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A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

Primary Purpose

Polymyositis, Dermatomyositis

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Ustekinumab 6 mg/kg
Ustekinumab 90 mg
Placebo IV
Placebo SC
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyositis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a diagnosis of polymyositis (PM)/ dermatomyositis (DM) made or confirmed by a physician (such as a rheumatologist, neurologist, or dermatologist) experienced in treatment of PM/DM at least 6 weeks prior to first dose of the study drug
  • Has PM or DM which is considered active despite receiving at least 1 standard-of-care treatment by the investigator
  • Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments: i) glucocorticoids, ii) 1 or 2 of the following immunomodulatory drugs: mycophenolate mofetil, azathioprine, oral methotrexate, oral tacrolimus, or oral cyclosporine A
  • Regular or as needed treatment with topical use of glucocorticoids are permitted to treat skin lesions on a stable dose for greater than or equal to (>=) 2 weeks prior to first dose of the study drug
  • Contraceptive (birth control) use by men or women should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
  • Must be medically stable on the basis of clinical laboratory tests performed at screening. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant
  • Demonstrable muscle weakness at screening and Week 0 measured by the Manual Muscle Testing (MMT)-8 less than or equal to (<=)135 units
  • Demonstrable muscle weakness at screening measured by any 2 or more of the followings: (i) PhGA greater than or equal to (>=) 1.5 centimeter (cm), (ii) 1 or more muscle enzymes (Creatine kinase [CK], and aldolase) >=1.4*upper limit of normal (ULN), (iii) Myositis disease activity assessment tool (MDAAT)-Extramuscular Global Assessment >=1.5 cm

Exclusion Criteria:

  • Has myositis other than PM/DM, including but not limited to amyopathic dermatomyositis (ADM), clinically amyopathic DM, juvenile DM, inclusion body myositis (IBM) immune-mediated necrotizing myopathy diagnosed based on muscle biopsy findings and positive anti-SRP or anti-HMGCR antibody, drug-induced myositis, PM associated with human immunodeficiency virus (HIV), and muscular dystrophy, congenital myopathy, metabolic myopathy, and mitochondrial myopathy
  • Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), psoriasis, or Crohn's disease
  • Has severe respiratory muscle weakness confirmed by the investigator based on the consultation with a pulmonologist and the measures of respiratory muscle strength such as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and/or maximal voluntary ventilation (MVV) measurements and lung capacity such as forced vital capacity (FVC). The results need to be within population appropriate normal limits
  • Has severe muscle damage (Myositis Damage Index-VAS [Muscle Damage] greater than (>) 7 centimeter [cm]), permanent weakness due to a non-IIM cause, or myositis with cardiac dysfunction
  • Has glucocorticoid-induced myopathy which the investigator considers the primary cause of muscle weakness
  • Has positive test result of anti-melanoma differentiation-associated protein 5 (MDA5) antibody (anti clinically amyopathic dermatomyositis (C-ADM)-140 antibody).
  • Has had a nontuberculous mycobacterial infection or opportunistic infection
  • Has a history of, or ongoing, chronic or recurrent infectious disease
  • Has past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple relapses of these conditions
  • Presence or history of malignancy within 5 years before screening

Sites / Locations

  • Tokyo Medical and Dental University Hospital
  • Fukushima Medical University Hospital
  • Shinko Hospital
  • Tokai University Hospital
  • Kagoshima University Hospital
  • St.Marianna University Hospital
  • National Hospital Organization Osaka Minami Medical Center
  • Hospital of the University of Occupational and Enviromental Health
  • Kumamoto University Hospital
  • Kurashiki Central Hospital
  • Shinshu University Hospital
  • Minaminagano Medical Center Shinonoi General Hospital
  • Nagasaki University Hospital
  • National Hospital Organization Nagoya Medical Center
  • Niigata University Medical & Dental Hospital
  • Okayama City General Medical Center Okayama City Hospital
  • Kitasato University Hospital
  • Saga University Hospital
  • Sakai City Medical Center
  • Tohoku University Hospital
  • Tohoku Medical And Pharmaceutical University Hospital
  • Dokkyo Medical University Hospital
  • The Jikei University Hospital
  • Juntendo University Hospital
  • Nippon Medical School Hospital
  • Tokyo Medical University Hospital
  • National Center for Global Health and Medicine
  • Ehime University Hospital
  • Fujita Health University Hospital
  • University of Tsukuba Hospital
  • Yamaguchi University Hospital
  • Yokohama Rosai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: Ustekinumab + Placebo

Group 2: Placebo + Ustekinumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants who achieve Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24
Minimal improvement is defined as IMACS TIS greater than or equal to (>=)20 in participants with polymyositis (PM)/ dermatomyositis (DM). The criteria use the 6 IMACS core set measures: Global Activity-VAS, Patient Global Activity-VAS, MMT-8, Muscle Enzymes, Extramuscular Assessment (MDAAT), and Functional Assessment (HAQ-DI). The absolute percentage change in each measure with varying weights is combined to obtain a Total Improvement Score (TIS) on a scale of 0 to 100. Higher score indicates greater improvement.

Secondary Outcome Measures

Change from Baseline in Functional Index-2 (FI-2) Score at Week 24
Change from baseline in functional Index-2 at Week 24 will be reported. The FI-2 is a functional outcome developed for participants with adult PM or DM to assess muscle endurance in 7 muscle groups. Each muscle group is scored as the number of correctly performed repetitions with 60 or 120 maximal number of repetitions depending on muscle group. The FI-2 is performed unilaterally, preferably on the participant's dominant side for muscle groups of shoulder, hip, and step test. The FI-2 has been validated as to content and construct validity and intra- and interrater reliability. The score ranges from 0-60 or 0-120 depending on the muscle group. Higher score indicates better muscle endurance.
Percentage of Participants who Experience Disease Worsening Through Week 24 Based on Consensus Criteria for Worsening
Percentage of participants who experience disease worsening through Week 24 based on consensus criteria for worsening will be reported. Criteria for disease worsening in a clinical trial were based on international consensus guideline developed by the IMACS. The worsening of disease is defined as 1 of the following criteria: Worsening of the Physician Global Activity by greater than or equal to (>=2) centimeter (cm) on a 10-cm 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 activity measures by >= 30% from baseline.
Change from Baseline in Manual Muscle Testing (MMT)-8 Score at Week 24
Change from baseline in MMT-8 score at Week 24 will be reported. Manual Muscle Testing is a partially validated tool to assess muscle strength. MMT-8 score ranges from 0-80, where maximal score is sum of scores from 8 muscle groups and each muscle group is scored on a 0 to 10-point scale. Higher score indicates greater muscle strength, that is, less impairment of muscle.
Change from Baseline in Physician Global Activity (PhGA) at Week 24
Change from baseline in physician global activity at Week 24 will be reported. Physician Global Activity is 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 10 cm VAS, where 0 cm= no evidence of disease activity and 10 cm= extremely active or severe disease activity.
Change from Baseline in Extramuscular Assessment (Myositis Disease Activity Assessment Tool [MDAAT]-Extramuscular Global Assessment) Score at Week 24
Change from baseline in extramuscular assessment (myositis disease activity assessment tool [MDAAT]-Extramuscular Global Assessment) Score at Week 24 will be reported. MDAAT is scored on a 10 cm scale ranging from 0-10 cm where, 0 cm = absent and 10 cm = maximum disease activity.
Change from Baseline in Muscle Enzymes at Week 24
Change from baseline in muscle enzyme like creatine kinase [CK], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactate dehydrogenase [LDH], and aldolase) at Week 24 measured as units/liter will be reported.

Full Information

First Posted
June 7, 2019
Last Updated
August 9, 2022
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT03981744
Brief Title
A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
The study did not meet the primary endpoint.
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyositis, Dermatomyositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Ustekinumab + Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Placebo + Ustekinumab
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 6 mg/kg
Other Intervention Name(s)
STELARA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 90 mg
Other Intervention Name(s)
STELARA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo IV
Intervention Description
Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
Intervention Type
Drug
Intervention Name(s)
Placebo SC
Intervention Description
Participants will receive SC dosing of placebo at Weeks 8,16 and 24.
Primary Outcome Measure Information:
Title
Percentage of Participants who achieve Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24
Description
Minimal improvement is defined as IMACS TIS greater than or equal to (>=)20 in participants with polymyositis (PM)/ dermatomyositis (DM). The criteria use the 6 IMACS core set measures: Global Activity-VAS, Patient Global Activity-VAS, MMT-8, Muscle Enzymes, Extramuscular Assessment (MDAAT), and Functional Assessment (HAQ-DI). The absolute percentage change in each measure with varying weights is combined to obtain a Total Improvement Score (TIS) on a scale of 0 to 100. Higher score indicates greater improvement.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in Functional Index-2 (FI-2) Score at Week 24
Description
Change from baseline in functional Index-2 at Week 24 will be reported. The FI-2 is a functional outcome developed for participants with adult PM or DM to assess muscle endurance in 7 muscle groups. Each muscle group is scored as the number of correctly performed repetitions with 60 or 120 maximal number of repetitions depending on muscle group. The FI-2 is performed unilaterally, preferably on the participant's dominant side for muscle groups of shoulder, hip, and step test. The FI-2 has been validated as to content and construct validity and intra- and interrater reliability. The score ranges from 0-60 or 0-120 depending on the muscle group. Higher score indicates better muscle endurance.
Time Frame
Baseline and Week 24
Title
Percentage of Participants who Experience Disease Worsening Through Week 24 Based on Consensus Criteria for Worsening
Description
Percentage of participants who experience disease worsening through Week 24 based on consensus criteria for worsening will be reported. Criteria for disease worsening in a clinical trial were based on international consensus guideline developed by the IMACS. The worsening of disease is defined as 1 of the following criteria: Worsening of the Physician Global Activity by greater than or equal to (>=2) centimeter (cm) on a 10-cm 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 activity measures by >= 30% from baseline.
Time Frame
Through Week 24
Title
Change from Baseline in Manual Muscle Testing (MMT)-8 Score at Week 24
Description
Change from baseline in MMT-8 score at Week 24 will be reported. Manual Muscle Testing is a partially validated tool to assess muscle strength. MMT-8 score ranges from 0-80, where maximal score is sum of scores from 8 muscle groups and each muscle group is scored on a 0 to 10-point scale. Higher score indicates greater muscle strength, that is, less impairment of muscle.
Time Frame
Baseline and Week 24
Title
Change from Baseline in Physician Global Activity (PhGA) at Week 24
Description
Change from baseline in physician global activity at Week 24 will be reported. Physician Global Activity is 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 10 cm VAS, where 0 cm= no evidence of disease activity and 10 cm= extremely active or severe disease activity.
Time Frame
Baseline and Week 24
Title
Change from Baseline in Extramuscular Assessment (Myositis Disease Activity Assessment Tool [MDAAT]-Extramuscular Global Assessment) Score at Week 24
Description
Change from baseline in extramuscular assessment (myositis disease activity assessment tool [MDAAT]-Extramuscular Global Assessment) Score at Week 24 will be reported. MDAAT is scored on a 10 cm scale ranging from 0-10 cm where, 0 cm = absent and 10 cm = maximum disease activity.
Time Frame
Baseline and Week 24
Title
Change from Baseline in Muscle Enzymes at Week 24
Description
Change from baseline in muscle enzyme like creatine kinase [CK], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactate dehydrogenase [LDH], and aldolase) at Week 24 measured as units/liter will be reported.
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a diagnosis of polymyositis (PM)/ dermatomyositis (DM) made or confirmed by a physician (such as a rheumatologist, neurologist, or dermatologist) experienced in treatment of PM/DM at least 6 weeks prior to first dose of the study drug Has PM or DM which is considered active despite receiving at least 1 standard-of-care treatment by the investigator Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments: i) glucocorticoids, ii) 1 or 2 of the following immunomodulatory drugs: mycophenolate mofetil, azathioprine, oral methotrexate, oral tacrolimus, or oral cyclosporine A Regular or as needed treatment with topical use of glucocorticoids are permitted to treat skin lesions on a stable dose for greater than or equal to (>=) 2 weeks prior to first dose of the study drug Contraceptive (birth control) use by men or women should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies Must be medically stable on the basis of clinical laboratory tests performed at screening. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant Demonstrable muscle weakness at screening and Week 0 measured by the Manual Muscle Testing (MMT)-8 less than or equal to (<=)135 units Demonstrable muscle weakness at screening measured by any 2 or more of the followings: (i) PhGA greater than or equal to (>=) 1.5 centimeter (cm), (ii) 1 or more muscle enzymes (Creatine kinase [CK], and aldolase) >=1.4*upper limit of normal (ULN), (iii) Myositis disease activity assessment tool (MDAAT)-Extramuscular Global Assessment >=1.5 cm Exclusion Criteria: Has myositis other than PM/DM, including but not limited to amyopathic dermatomyositis (ADM), clinically amyopathic DM, juvenile DM, inclusion body myositis (IBM) immune-mediated necrotizing myopathy diagnosed based on muscle biopsy findings and positive anti-SRP or anti-HMGCR antibody, drug-induced myositis, PM associated with human immunodeficiency virus (HIV), and muscular dystrophy, congenital myopathy, metabolic myopathy, and mitochondrial myopathy Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), psoriasis, or Crohn's disease Has severe respiratory muscle weakness confirmed by the investigator based on the consultation with a pulmonologist and the measures of respiratory muscle strength such as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and/or maximal voluntary ventilation (MVV) measurements and lung capacity such as forced vital capacity (FVC). The results need to be within population appropriate normal limits Has severe muscle damage (Myositis Damage Index-VAS [Muscle Damage] greater than (>) 7 centimeter [cm]), permanent weakness due to a non-IIM cause, or myositis with cardiac dysfunction Has glucocorticoid-induced myopathy which the investigator considers the primary cause of muscle weakness Has positive test result of anti-melanoma differentiation-associated protein 5 (MDA5) antibody (anti clinically amyopathic dermatomyositis (C-ADM)-140 antibody). Has had a nontuberculous mycobacterial infection or opportunistic infection Has a history of, or ongoing, chronic or recurrent infectious disease Has past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple relapses of these conditions Presence or history of malignancy within 5 years before screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Shinko Hospital
City
Hyogo
ZIP/Postal Code
651-0072
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima City
ZIP/Postal Code
890-8544
Country
Japan
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
National Hospital Organization Osaka Minami Medical Center
City
Kawachi-Nagano
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Hospital of the University of Occupational and Enviromental Health
City
Kita-kyushu
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Minaminagano Medical Center Shinonoi General Hospital
City
Nagano
ZIP/Postal Code
388-8004
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Okayama City General Medical Center Okayama City Hospital
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Sakai City Medical Center
City
Sakai City
ZIP/Postal Code
593-8304
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tohoku Medical And Pharmaceutical University Hospital
City
Sendai
ZIP/Postal Code
983-8512
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
The Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Ehime University Hospital
City
Toon
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Yokohama Rosai Hospital
City
Yokohama
ZIP/Postal Code
222-0036
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

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