Back to resultsA Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis (THEIA)
Primary Purpose
Giant Cell Arteritis
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Giant Cell Arteritis
Eligibility Criteria
Inclusion criteria
- Diagnosis of Giant cell arteritis (GCA) according to the revised American College of Rheumatology criteria
- GCA diagnosis confirmed by either temporal artery biopsy revealing features of GCA either at time of diagnosis or at other timepoint during disease history; or evidence of cranial GCA either at time of diagnosis or at other timepoint during disease history by cranial doppler-ultrasound; or cranial Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography; or other imaging modality upon agreement with the sponsor or evidence of GCA by angiography or cross-sectional imaging (ultrasound, MRI, computed tomography [CT], positron emission tomography [PET])
- Have new onset or relapsing GCA
- Have active GCA within 6 weeks of first study intervention: Active GCA: presence of signs and symptoms of GCA and elevated erythrocyte sedimentation rate (ESR) greater than or equal to (>=) 30 millimeter per hour (mm/hour), or C-reactive protein (CRP) >= 10 milligrams per liter (mg/L) (or 1 milligrams per deciliter [mg/dL]), attributed to active GCA. ESR >= 30 mm/hour or CRP >= 10 mg/L (or 1 mg/dL) is not required if active GCA has been confirmed by a positive temporal artery biopsy or ultrasound or other imaging modality within 6 weeks of first study intervention
- Clinically stable GCA disease on a glucocorticoid (GC) dose between 20 and 60 milligrams per day (mg/day) (prednisone or equivalent) at randomization such that the participant is able to safely participate in the protocol defined prednisone taper regimen, in the opinion of the investigator
Exclusion criteria
- Has any known severe or uncontrolled GCA complications
- Has any rheumatic disease other than GCA such that could interfere with assessment of GCA
- Has a current diagnosis or signs or symptoms of severe, progressive, or concomitant medical condition that places the participant at risk by participating in this study)
- Has or has had any major ischemic event, within 12 weeks of first study intervention. Has a personal history of arterial thrombosis or venous thromboembolism (including deep venous thrombosis [DVT] and Pulmonary Embolism [PE])
- Has any comorbidities requiring 3 or more courses of systemic GCs within 12 months of first study intervention, AND, inability, in the opinion of the investigator, to withdraw GC therapy through protocol-defined taper regimen due to suspected or established adrenal insufficiency, OR, currently on systemic chronic GC therapy for reasons other than GCA and be GC dependent and have the potential to flare due to GC tapering (e.g. unstable asthma, unstable COPD)
- Has a history of, or ongoing, chronic or recurrent infectious disease
- Has received within specified timeframe, or 5 half-lives (whichever is greater) , or has failed treatment with any investigational or approved biologic agents or Janus Kinase Inhibitor prior to first study intervention
- Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start: Any cytotoxic agents (cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents) with 6 months; Hydroxychloroquine, cyclosporine A, azathioprine, tacrolimus, sirolimus, sulfasalazine, leflunomide with cholestyramine washout or mycophenolate mofetil/mycophenolic acid within 3 months; Intramuscular, intra-articular, intrabursal, epidural, intra-lesional or IV GCs within 6 week; and Methotrexate (MTX) within 12 weeks. If started MTX >12 weeks prior to first study intervention MTX must have been at a stable dose for minimally 4 weeks and must not be receiving more than 25 mg oral or SC MTX per week
- Has chronic continuous use of systemic GCs for greater than (>) 4 years or inability, in the opinion of the investigator, to withdraw GC treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency
Sites / Locations
- University of Kansas Medical Center
- Massachusetts General Hospital
- Cliniques Universitaires St-Luc
- UZ Leuven Gasthuisberg
- Mount Sinai Hospital
- Hopital du Sacre-Coeur de Montreal
- CHU Dijon
- Hopital Cochin
- Universitätsklinikum Erlangen
- medius KLINIK KIRCHHEIM
- Universitatsklinik Tubingen
- Bnai Zion Medical Center
- Hadassah Medical Center
- Rabin Medical Center, Beilinson Campus
- Tel Aviv Sourasky Medical Center
- Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico
- Ospedale San Raffaele
- Azienda Ospedaliera di Padova
- Fondazione IRCCS Policlinico San Matteo
- Azienda USL 4 Prato
- ASUI Santa Maria della Misericordia di Udine
- Szpital Uniwersytecki Nr 2 w Bydgoszczy
- Szpital Specjalistyczny im. J. Dietla
- NZOZ Lecznica MAK-MED. S.C.
- Hosp. Univ. A Coruña
- Hosp. Clinic I Provincial de Barcelona
- Hosp. Clinico San Carlos
- Hosp. Univ. 12 de Octubre
- Hosp. Regional Univ. de Malaga
- Hosp. Univ. Marques de Valdecilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Guselkumab
Placebo
Arm Description
Participants will receive guselkumab subcutaneously (SC) every 4 weeks from Week 0 through Wweek 48. This will be in combination with a protocol specified 26-week GC taper. Participants of the long-term extension (LTE) period will continue to receive subcutaneous (SC) injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a Giant cell arteritis (GCA) flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.
Participants will receive matching placebo SC every 4 weeks from Week 0 through Week 48. This will be in combination with a protocol-specified 26-week GC taper. Participants of the LTE period will continue to receive SC injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a GCA flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission
Percentage of participants achieving GC-free remission will be assessed.
Secondary Outcome Measures
Percentage of Participants Achieving GC-Free Remission
Percentage of participants achieving GC-free remission will be assessed.
Percentage of Participants Achieving GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR)
Percentage of participants achieving GC-free remission and normalization of ESR will be assessed using the Westergren method.
Percentage of Participants Achieving GC-Free Remission and Normalization of C-Reactive Protein (CRP)
Percentage of participants achieving GC-free remission and normalization of CRP will be assessed.
Percentage of Participants Achieving GC-Free Remission and Normalization of Both ESR and CRP
Percentage of participants achieving normalization of both ESR and CRP will be assessed.
Cumulative GC dose
Cumulative GC dose will be assessed.
Time to First GCA Disease Flare or Discontinuation of Study Intervention due to AE of Worsening of GCA
The time to first GCA disease flare or discontinuation of study intervention due to AE of worsening of GCA will be assessed. Flare is defined as the recurrence of signs and symptoms of GCA, with or without elevation of inflammatory markers, and the necessity for an increase in GC dose for GCA.
Number of GCA Disease Flares or Discontinuation of Study Intervention due to AE of Worsening of GCA
Number of GCA disease flares or discontinuation of study intervention due to AE of worsening of GCA will be assessed.
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) occurring at or after the initial administration of study intervention through the day of last dose plus 12 weeks (up to Week 60) is considered to be treatment emergent. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An adverse event does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Number of Participants with TEAEs by System Organ Class With a Frequency Threshold of 5 percent (%) or More
An AE occurring at or after the initial administration of study intervention through the day of last dose plus 12 weeks is considered to be treatment emergent. An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An adverse event does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Number of Participants with Treatment Emergent Serious Adverse Event (SAEs)
SAE is any untoward medical occurrence that at any dose 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.
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Number of participants with clinically significant abnormalities in vital signs (Temperature, pulse/heart rate, respiratory rate and blood pressure) will be assessed.
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Number of participants with clinically significant abnormalities in laboratory parameters (blood chemistry, hematology, coagulation, serology) will be assessed.
Serum Concentrations of Guselkumab
Serum concentrations of guselkumab will be assessed in participants receiving active study intervention.
Number of Participants with Antibodies to Guselkumab
Number of participants with antibodies to guselkumab will be assessed in participants receiving active study intervention.
Full Information
NCT ID
NCT04633447
First Posted
November 6, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04633447
Brief Title
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
Acronym
THEIA
Official Title
A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
November 23, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).
Detailed Description
Giant cell arteritis (GCA) is a non-necrotizing granulomatous systemic vasculitis of unknown etiology affecting medium-sized and large arteries usually accompanied or preceded by systemic inflammation. Guselkumab is a monoclonal antibody (mAb) that binds to the p19 sub-unit of human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production. It is used in treatment of psoriatic arthritis, generalized pustular psoriasis, erythrodermic psoriasis. The study consists of a screening period (less than or equal to [<=] 6 weeks), double-blind treatment period (48 weeks), and safety follow-up period (12 weeks). Participants who complete the Week 52 visit and are assessed to be in glucocorticoid (GC)-free remission, may have the option to participate in the long-term extension (LTE) period of the study for up to 12 months. This study will evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of guselkumab in combination with a 26-week GC taper regimen for the treatment of active new-onset or relapsing GCA in adult participants. The total duration of the study is up to 66 weeks for the main study and for participants that continue in the LTE period, the total study duration will be up to 112 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab subcutaneously (SC) every 4 weeks from Week 0 through Wweek 48. This will be in combination with a protocol specified 26-week GC taper. Participants of the long-term extension (LTE) period will continue to receive subcutaneous (SC) injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a Giant cell arteritis (GCA) flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive matching placebo SC every 4 weeks from Week 0 through Week 48. This will be in combination with a protocol-specified 26-week GC taper. Participants of the LTE period will continue to receive SC injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a GCA flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
Tremfya, CNTO 1959
Intervention Description
Guselkumab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered subcutaneously.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission
Description
Percentage of participants achieving GC-free remission will be assessed.
Time Frame
At Week 28
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving GC-Free Remission
Description
Percentage of participants achieving GC-free remission will be assessed.
Time Frame
From Week 28 up to Week 52
Title
Percentage of Participants Achieving GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR)
Description
Percentage of participants achieving GC-free remission and normalization of ESR will be assessed using the Westergren method.
Time Frame
At Week 28 and up to Week 52
Title
Percentage of Participants Achieving GC-Free Remission and Normalization of C-Reactive Protein (CRP)
Description
Percentage of participants achieving GC-free remission and normalization of CRP will be assessed.
Time Frame
At Week 28 and up to Week 52
Title
Percentage of Participants Achieving GC-Free Remission and Normalization of Both ESR and CRP
Description
Percentage of participants achieving normalization of both ESR and CRP will be assessed.
Time Frame
At Week 28 and up to Week 52
Title
Cumulative GC dose
Description
Cumulative GC dose will be assessed.
Time Frame
Through Week 28 up to Week 52
Title
Time to First GCA Disease Flare or Discontinuation of Study Intervention due to AE of Worsening of GCA
Description
The time to first GCA disease flare or discontinuation of study intervention due to AE of worsening of GCA will be assessed. Flare is defined as the recurrence of signs and symptoms of GCA, with or without elevation of inflammatory markers, and the necessity for an increase in GC dose for GCA.
Time Frame
Through Week 28 up to Week 52
Title
Number of GCA Disease Flares or Discontinuation of Study Intervention due to AE of Worsening of GCA
Description
Number of GCA disease flares or discontinuation of study intervention due to AE of worsening of GCA will be assessed.
Time Frame
Through Week 28 up to Week 52
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) occurring at or after the initial administration of study intervention through the day of last dose plus 12 weeks (up to Week 60) is considered to be treatment emergent. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An adverse event does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time Frame
Up to Week 60
Title
Number of Participants with TEAEs by System Organ Class With a Frequency Threshold of 5 percent (%) or More
Description
An AE occurring at or after the initial administration of study intervention through the day of last dose plus 12 weeks is considered to be treatment emergent. An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An adverse event does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time Frame
Up to Week 60
Title
Number of Participants with Treatment Emergent Serious Adverse Event (SAEs)
Description
SAE is any untoward medical occurrence that at any dose 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.
Time Frame
Up to Week 60
Title
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Description
Number of participants with clinically significant abnormalities in vital signs (Temperature, pulse/heart rate, respiratory rate and blood pressure) will be assessed.
Time Frame
Up to Week 60
Title
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Description
Number of participants with clinically significant abnormalities in laboratory parameters (blood chemistry, hematology, coagulation, serology) will be assessed.
Time Frame
Up to Week 60
Title
Serum Concentrations of Guselkumab
Description
Serum concentrations of guselkumab will be assessed in participants receiving active study intervention.
Time Frame
Up to Week 52
Title
Number of Participants with Antibodies to Guselkumab
Description
Number of participants with antibodies to guselkumab will be assessed in participants receiving active study intervention.
Time Frame
Up to Week 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Diagnosis of Giant cell arteritis (GCA) according to the revised American College of Rheumatology criteria
GCA diagnosis confirmed by either temporal artery biopsy revealing features of GCA either at time of diagnosis or at other timepoint during disease history; or evidence of cranial GCA either at time of diagnosis or at other timepoint during disease history by cranial doppler-ultrasound; or cranial Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography; or other imaging modality upon agreement with the sponsor or evidence of GCA by angiography or cross-sectional imaging (ultrasound, MRI, computed tomography [CT], positron emission tomography [PET])
Have new onset or relapsing GCA
Have active GCA within 6 weeks of first study intervention: Active GCA: presence of signs and symptoms of GCA and elevated erythrocyte sedimentation rate (ESR) greater than or equal to (>=) 30 millimeter per hour (mm/hour), or C-reactive protein (CRP) >= 10 milligrams per liter (mg/L) (or 1 milligrams per deciliter [mg/dL]), attributed to active GCA. ESR >= 30 mm/hour or CRP >= 10 mg/L (or 1 mg/dL) is not required if active GCA has been confirmed by a positive temporal artery biopsy or ultrasound or other imaging modality within 6 weeks of first study intervention
Clinically stable GCA disease on a glucocorticoid (GC) dose between 20 and 60 milligrams per day (mg/day) (prednisone or equivalent) at randomization such that the participant is able to safely participate in the protocol defined prednisone taper regimen, in the opinion of the investigator
Exclusion criteria
Has any known severe or uncontrolled GCA complications
Has any rheumatic disease other than GCA such that could interfere with assessment of GCA
Has a current diagnosis or signs or symptoms of severe, progressive, or concomitant medical condition that places the participant at risk by participating in this study)
Has or has had any major ischemic event, within 12 weeks of first study intervention. Has a personal history of arterial thrombosis or venous thromboembolism (including deep venous thrombosis [DVT] and Pulmonary Embolism [PE])
Has any comorbidities requiring 3 or more courses of systemic GCs within 12 months of first study intervention, AND, inability, in the opinion of the investigator, to withdraw GC therapy through protocol-defined taper regimen due to suspected or established adrenal insufficiency, OR, currently on systemic chronic GC therapy for reasons other than GCA and be GC dependent and have the potential to flare due to GC tapering (e.g. unstable asthma, unstable COPD)
Has a history of, or ongoing, chronic or recurrent infectious disease
Has received within specified timeframe, or 5 half-lives (whichever is greater) , or has failed treatment with any investigational or approved biologic agents or Janus Kinase Inhibitor prior to first study intervention
Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start: Any cytotoxic agents (cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents) with 6 months; Hydroxychloroquine, cyclosporine A, azathioprine, tacrolimus, sirolimus, sulfasalazine, leflunomide with cholestyramine washout or mycophenolate mofetil/mycophenolic acid within 3 months; Intramuscular, intra-articular, intrabursal, epidural, intra-lesional or IV GCs within 6 week; and Methotrexate (MTX) within 12 weeks. If started MTX >12 weeks prior to first study intervention MTX must have been at a stable dose for minimally 4 weeks and must not be receiving more than 25 mg oral or SC MTX per week
Has chronic continuous use of systemic GCs for greater than (>) 4 years or inability, in the opinion of the investigator, to withdraw GC treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Cliniques Universitaires St-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
medius KLINIK KIRCHHEIM
City
Kirchheim unter Teck
ZIP/Postal Code
73230
Country
Germany
Facility Name
Universitatsklinik Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Bnai Zion Medical Center
City
Hifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35121
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda USL 4 Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
ASUI Santa Maria della Misericordia di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Szpital Uniwersytecki Nr 2 w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Szpital Specjalistyczny im. J. Dietla
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED. S.C.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Regional Univ. de Malaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
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 to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
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