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A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)

Primary Purpose

Takayasu Arteritis

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Ustekinumab
Placebo
Glucorticoid Taper Regimen
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takayasu Arteritis

Eligibility Criteria

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

Inclusion Criteria:

  • Must have developed a relapse of Takayasu Arteritis (TAK) within 12 weeks prior to administration of study intervention and the relapse must have occurred at a dose of at least 7.5 milligrams (mg)/day (prednisolone or equivalent)
  • Must be receiving oral glucorticoid (GC) treatment of greater than or equal to (>=)15 mg/day (prednisolone or equivalent), inclusive for the treatment of relapsing TAK and be on a stable dose for at least 2 weeks prior to the first administration of study intervention
  • If receiving an oral anti-platelet therapy (including but not limited to aspirin, clopidogrel, ticlopidine) or anti-coagulation therapy (including but not limited to warfarin) for treatment of TAK, the dose must have been stable for at least 2 weeks prior to first administration of the study intervention. In terms of warfarin, the dose should be controlled 1-5mg/day to maintain Prothrombin Time and International Normalized Ratio (PT-INR) target range between 2.0-3.0 (if participants are over 70 years old, PT-INR target range should be between 1.6-2.6)
  • Have no history of latent or active Tuberculosis (TB) prior to screening. An exception is made for participants who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB at least 3 weeks prior to the first administration of the study intervention, or have documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of the study intervention. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation
  • If receiving an oral anti-hypertensive therapy for treatment of TAK, the dose must have been stable for at least 2 weeks prior to first administration of the study intervention

Exclusion Criteria:

  • Has currently any known severe or uncontrolled TAK complications (example, hypertension not responding to adequate treatment, aortic incompetence with cardiac insufficiency, progressing aortic aneurysm, coronary artery lesions with severe stenosis)
  • Has received immunosuppressant (s) (including but not limited to Methotrexate [MTX], Azathioprine [AZA], Mycophenolate Mofetil [MMF], oral Triamcinolone [TAC], oral Cyclosporine A) within 4 weeks of first study intervention
  • Has had a Bacille Calmette-guerin (BCG) vaccination within 12 months of screening
  • Any major illness/condition or evidence of an unstable clinical condition example, history of liver or renal insufficiency (estimated creatinine clearance below 60 milliliters/minute [mL/min]); significant (cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances), disease of any organ system or active acute or chronic infection/infectious illness that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study
  • Having a condition that is steroid dependent (example, steroid dependent asthma, chronic obstructive pulmonary disease, et cetera) that is not amenable to tapering oral GC

Sites / Locations

  • Tokyo Medical and Dental University Hospital
  • Chiba University Hospital
  • Kyushu University Hospital
  • Hamamatsu University Hospital
  • Saitama Medical University Hospital
  • Kagawa University Hospital
  • Kobe University Hospital
  • Kyoto University Hospital
  • Matsuyama Red Cross Hospital
  • Nagoya City University Hospital
  • Niigata University Medical & Dental Hospital
  • Okayama University Hospital
  • Kindai University Hospital
  • Kitano Hospital
  • Rinku General Medical Center
  • Kitasato University Hospital
  • Hokkaido University Hospital
  • Sapporo Medical University Hospital
  • Tohoku University Hospital
  • National Cerebral and Cardiovascular Center
  • Mitsui Memorial Hospital
  • St. Luke's International Hospital
  • National Center for Global Health and Medicine
  • Fujita Health University Hospital
  • University of Tsukuba Hospital
  • Wakayama Medical University Hospital
  • Tottori University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ustekinumab

Placebo

Arm Description

Double-blind (DB) Period: Participants will receive weight-ranged based ustekinumab (6 milligrams/kilogram[mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90mg injection SC 8 weeks after initial IV dose, then every 8 weeks (q8w) thereafter until the end of the DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. Open Label Extension (OLE) period: Participants will receive ustekinumab SC injection at Week OL-0, followed by ustekinumab 90mg SC injection with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from first SC administration after end of DB period whichever is later. Long-term Extension (LTE) Period: Participants who completed OLE period may be eligible to enter LTE and continue to receive ustekinumab 90mg SC injection q8w.

DB period: Participants will receive placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then q8w thereafter until the end of DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. OLE period: Participants will receive ustekinumab SC at Week OL-0, followed by SC administration of ustekinumab with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from the first SC administration after the end of DB period, whichever is later. LTE Period: Participants who complete their participation in OLE period may be eligible to enter the LTE and continue to receive 90 mg SC ustekinumab q8w.

Outcomes

Primary Outcome Measures

Time to Relapse Through the End of Double-blind (DB) Period
Time to relapse is defined as the assessment of 'signs of relapse present' as judged by the investigator for at least 2 of 5 categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms.

Secondary Outcome Measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Time to Relapse of TAK by Kerr's Criteria Through the End of DB Period
Time to relapse is defined as the assessment of 'signs of relapse present as judged by the investigator for at least 2 of 4 categories: systemic symptoms (objective or subjective), elevated inflammation markers, vascular signs, and symptoms and ischemic symptoms.
Time to Relapse Based on Clinical Symptoms Through the End of DB Period
Time to relapse based on clinical symptoms through the end of DB period will be reported. Participants who meet at least 1 category in the following 4 clinical categories will be considered as relapse per clinical symptom: 1) Objective systemic symptoms; 2) Subjective systemic symptoms; 3) Vascular signs and symptoms; 4) Ischemic symptoms.
Time to Relapse of TAK in Each of the 5 Categories Through the End of DB Period
Time to relapse is defined as the assessment of 'signs of relapse present' as judged by the investigator in each of the 5 categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms.
Percentage of Participants with Relapse in Each of the 5 Categories Through the End of DB Period
Percentage of participants with relapse in each of the 5 categories (objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms) through the end of DB period will be reported.
Cumulative Oral Glucocorticoid (GC) Dose Through the End of DB Period
Cumulative oral GC dose (prednisolone or equivalent) through the end of DB period will be reported.
Change from Baseline in Oral GC Dose Through the End of DB Period
Change from baseline in oral GC dose (prednisolone or equivalent) through the end of DB period will be reported.
Number of Participants Achieving GC Dose of 5 milligrams (mg)/day or Less Through the End of DB Period
Number of participants achieving GC dose of 5 mg/day or less at the end of DB period will be reported.
Number of Participants with Change from Baseline in Imaging Evaluation Through the End of DB Period
Number of participants with change from baseline in imaging evaluation through the end of DB period will be reported. Vessel involvement such as stenosis, obstruction, and aneurysm; arterial wall thickness; and the presence of mural contrast enhancement and oedema will be assessed for imaging evaluation using magnetic resonance angiography (MRA).
Change from Baseline in C-reactive Protein (CRP) Through the End of DB Period
Change from baseline in CRP through the end of DB period will be reported.
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Through the End of DB Period
Change from baseline in ESR through the end of DB period will be reported.
Serum Concentrations of Ustekinumab
Serum concentrations of ustekinumab will be reported.
Number of Participants with Positive Anti-ustekinumab Antibodies
Number of participants with positive anti-ustekinumab antibodies will be reported.

Full Information

First Posted
May 10, 2021
Last Updated
July 27, 2023
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT04882072
Brief Title
A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Takayasu Arteritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to difficulties in enrollment and ongoing feasibility issues
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 25, 2023 (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 compared to placebo, in combination with oral glucocorticoid (GC) taper regimen, in participants with relapsing Takayasu Arteritis (TAK).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takayasu Arteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ustekinumab
Arm Type
Experimental
Arm Description
Double-blind (DB) Period: Participants will receive weight-ranged based ustekinumab (6 milligrams/kilogram[mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90mg injection SC 8 weeks after initial IV dose, then every 8 weeks (q8w) thereafter until the end of the DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. Open Label Extension (OLE) period: Participants will receive ustekinumab SC injection at Week OL-0, followed by ustekinumab 90mg SC injection with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from first SC administration after end of DB period whichever is later. Long-term Extension (LTE) Period: Participants who completed OLE period may be eligible to enter LTE and continue to receive ustekinumab 90mg SC injection q8w.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
DB period: Participants will receive placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then q8w thereafter until the end of DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. OLE period: Participants will receive ustekinumab SC at Week OL-0, followed by SC administration of ustekinumab with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from the first SC administration after the end of DB period, whichever is later. LTE Period: Participants who complete their participation in OLE period may be eligible to enter the LTE and continue to receive 90 mg SC ustekinumab q8w.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
Stelara®, CNTO1275
Intervention Description
Participants will receive IV infusion and SC injection of ustekinumab.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive IV infusion and SC injection of matching placebo.
Intervention Type
Drug
Intervention Name(s)
Glucorticoid Taper Regimen
Intervention Description
Glucocorticoid will be administered orally.
Primary Outcome Measure Information:
Title
Time to Relapse Through the End of Double-blind (DB) Period
Description
Time to relapse is defined as the assessment of 'signs of relapse present' as judged by the investigator for at least 2 of 5 categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms.
Time Frame
Up to occurrence of 35 events (Up to 24 months)
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to 3 years
Title
Number of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to 3 years
Title
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Description
SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to 3 years
Title
Time to Relapse of TAK by Kerr's Criteria Through the End of DB Period
Description
Time to relapse is defined as the assessment of 'signs of relapse present as judged by the investigator for at least 2 of 4 categories: systemic symptoms (objective or subjective), elevated inflammation markers, vascular signs, and symptoms and ischemic symptoms.
Time Frame
Up to occurrence of 35 events (Up to 24 months)
Title
Time to Relapse Based on Clinical Symptoms Through the End of DB Period
Description
Time to relapse based on clinical symptoms through the end of DB period will be reported. Participants who meet at least 1 category in the following 4 clinical categories will be considered as relapse per clinical symptom: 1) Objective systemic symptoms; 2) Subjective systemic symptoms; 3) Vascular signs and symptoms; 4) Ischemic symptoms.
Time Frame
Up to occurrence of 35 events (Up to 24 months)
Title
Time to Relapse of TAK in Each of the 5 Categories Through the End of DB Period
Description
Time to relapse is defined as the assessment of 'signs of relapse present' as judged by the investigator in each of the 5 categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms.
Time Frame
Up to occurrence of 35 events (Up to 24 months)
Title
Percentage of Participants with Relapse in Each of the 5 Categories Through the End of DB Period
Description
Percentage of participants with relapse in each of the 5 categories (objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms) through the end of DB period will be reported.
Time Frame
Up to occurrence of 35 events (Up to 24 months)
Title
Cumulative Oral Glucocorticoid (GC) Dose Through the End of DB Period
Description
Cumulative oral GC dose (prednisolone or equivalent) through the end of DB period will be reported.
Time Frame
Up to occurrence of 35 events (Up to 24 months)
Title
Change from Baseline in Oral GC Dose Through the End of DB Period
Description
Change from baseline in oral GC dose (prednisolone or equivalent) through the end of DB period will be reported.
Time Frame
Baseline; up to the end of DB period (Up to 24 months)
Title
Number of Participants Achieving GC Dose of 5 milligrams (mg)/day or Less Through the End of DB Period
Description
Number of participants achieving GC dose of 5 mg/day or less at the end of DB period will be reported.
Time Frame
Up to 24 months
Title
Number of Participants with Change from Baseline in Imaging Evaluation Through the End of DB Period
Description
Number of participants with change from baseline in imaging evaluation through the end of DB period will be reported. Vessel involvement such as stenosis, obstruction, and aneurysm; arterial wall thickness; and the presence of mural contrast enhancement and oedema will be assessed for imaging evaluation using magnetic resonance angiography (MRA).
Time Frame
Baseline, every 24 weeks from Week 0 and relapse confirmation visit (Up to 24 months)
Title
Change from Baseline in C-reactive Protein (CRP) Through the End of DB Period
Description
Change from baseline in CRP through the end of DB period will be reported.
Time Frame
Baseline; up to 24 months
Title
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Through the End of DB Period
Description
Change from baseline in ESR through the end of DB period will be reported.
Time Frame
Baseline; up to 24 months
Title
Serum Concentrations of Ustekinumab
Description
Serum concentrations of ustekinumab will be reported.
Time Frame
Up to end of study (Up to 3 years)
Title
Number of Participants with Positive Anti-ustekinumab Antibodies
Description
Number of participants with positive anti-ustekinumab antibodies will be reported.
Time Frame
Up to end of study (Up to 3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have developed a relapse of Takayasu Arteritis (TAK) within 12 weeks prior to administration of study intervention and the relapse must have occurred at a dose of at least 7.5 milligrams (mg)/day (prednisolone or equivalent) Must be receiving oral glucorticoid (GC) treatment of greater than or equal to (>=)15 mg/day (prednisolone or equivalent), inclusive for the treatment of relapsing TAK and be on a stable dose for at least 2 weeks prior to the first administration of study intervention If receiving an oral anti-platelet therapy (including but not limited to aspirin, clopidogrel, ticlopidine) or anti-coagulation therapy (including but not limited to warfarin) for treatment of TAK, the dose must have been stable for at least 2 weeks prior to first administration of the study intervention. In terms of warfarin, the dose should be controlled 1-5mg/day to maintain Prothrombin Time and International Normalized Ratio (PT-INR) target range between 2.0-3.0 (if participants are over 70 years old, PT-INR target range should be between 1.6-2.6) Have no history of latent or active Tuberculosis (TB) prior to screening. An exception is made for participants who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB at least 3 weeks prior to the first administration of the study intervention, or have documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of the study intervention. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation If receiving an oral anti-hypertensive therapy for treatment of TAK, the dose must have been stable for at least 2 weeks prior to first administration of the study intervention Exclusion Criteria: Has currently any known severe or uncontrolled TAK complications (example, hypertension not responding to adequate treatment, aortic incompetence with cardiac insufficiency, progressing aortic aneurysm, coronary artery lesions with severe stenosis) Has received immunosuppressant (s) (including but not limited to Methotrexate [MTX], Azathioprine [AZA], Mycophenolate Mofetil [MMF], oral Triamcinolone [TAC], oral Cyclosporine A) within 4 weeks of first study intervention Has had a Bacille Calmette-guerin (BCG) vaccination within 12 months of screening Any major illness/condition or evidence of an unstable clinical condition example, history of liver or renal insufficiency (estimated creatinine clearance below 60 milliliters/minute [mL/min]); significant (cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances), disease of any organ system or active acute or chronic infection/infectious illness that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study Having a condition that is steroid dependent (example, steroid dependent asthma, chronic obstructive pulmonary disease, et cetera) that is not amenable to tapering oral GC
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
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-Gun
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Matsuyama Red Cross Hospital
City
Matsuyama-City
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya-City
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka-Sayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
Rinku General Medical Center
City
Osaka
ZIP/Postal Code
598-8577
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-Shi
ZIP/Postal Code
564-8565
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Tokyo
ZIP/Postal Code
101-8643
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-8655
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
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago
ZIP/Postal Code
683-8504
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 Takayasu Arteritis (TAK)

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