Clinical trial NCT02641392: A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Official title: A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
GED 0301
Mongersen
Safety
Irritable Bowel Disease
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 310
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

Detailed description: This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.

There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3 possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned based on clinical improvement achieved or not achieved from the core GED-0301 study.

1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208;
3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
4. continuous GED-0301 40 mg once daily through Week 208;
5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4 weeks, through Week 208.

The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety findings were noted.

Eligibility criteria: Inclusion Criteria for Adult Subjects:

Subjects must satisfy the following criteria to be screened and enrolled in the study:

* Male or female ≥ 18 years of age.
* Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.
* Subject must use protocol approved contraception.

Inclusion Criteria for Adolescent Subjects:

Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study

* Male or female 12 to 17 years of age.
* Subject must have participated in the GED 0301 CD 003 study.
* Subject is able to swallow the IP tablets.
* Subject must use protocol approved contraception.

Exclusion Criteria for Adult and Adolescent Subjects:

The presence of any of the following will exclude a subject from screening and enrollment:

* Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study.
* Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.
* Subject is pregnant or breastfeeding.
* Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208
timeFrame: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Medical Associates Research Group Inc.
state: California
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Pratt
country: United States
facility: Health Science Research Center, LLC
state: Kansas
city: Wichita
country: United States
facility: Via Christi Research a division of Via Christi Hospitals Wichita Inc
state: Kansas
city: Baton Rouge
country: United States
facility: Gastroenterology Associates LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan PLC
state: Michigan
city: Belton
country: United States
facility: Ehrhardt Clinical Research LLC
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Wilmington
country: United States
facility: Trial Management Associates LLC
state: North Carolina
city: Chattanooga
country: United States
facility: ClinSearch LLC
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute LLC
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants - Dallas
state: Texas
city: Flower Mound
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Sagact Pllc
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Five Dock
country: Australia
facility: Centre For Digestive Diseases
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Bentleigh East
country: Australia
facility: Monash Medical Centre Clayton
city: Graz
country: Austria
facility: LKH Universitaetsklinikum Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
city: Linz
country: Austria
facility: KH der Barmherzigen Bruder Linz
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: St Veit An Der Glan
country: Austria
facility: KH der Barmherzigen Brüder St.Veit an der Glan
city: Wein
country: Austria
facility: Krankenanstalt Rudolfstiftung Wien
city: Wein
country: Austria
facility: AKH Medizinische Universitat Wien
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Plovdiv
country: Bulgaria
facility: MHAT Kaspela EOOD
city: Ruse
country: Bulgaria
facility: MHAT Ruse AD
city: Sofia
country: Bulgaria
facility: Second MHAT Sofia AD
city: Sofia
country: Bulgaria
facility: City Clinic UMHAC EOOD
city: Sofia
country: Bulgaria
facility: UMHAT Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: MHAT Doverie AD
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Edmonton
country: Canada
facility: South Edmonton Gastroenterology
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research
state: British Columbia
city: Brandon
country: Canada
facility: Brandon Medical Arts Clinic
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University Health Sciences Center
state: Ontario
city: London
country: Canada
facility: London Health Science Center U. Hospital
state: Ontario
city: London
country: Canada
facility: LHSC Victoria Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Montfort Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc
state: Ontario
city: Waterloo
country: Canada
facility: Medicine Professional Corporation
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre de sante et de services sociaux Champlain Charles Le Moyne
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre Glen Site Royal Victoria Hospital
state: Quebec
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv Anny v Brne
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK
city: Olomouc
country: Czechia
facility: PreventaMed
city: Praha 3
country: Czechia
facility: CCBR Prague CZ
city: Aahus C
country: Denmark
facility: Aarhus Universitetshospital
city: Alborg
country: Denmark
facility: Alborg Universitets Hospital
city: Frederikssund
country: Denmark
facility: Nordsjaellands Hospital Frederikssund
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Koge
country: Denmark
facility: Koge Sygehus
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
city: Amiens Cedex
country: France
facility: CHU Amiens Hopital Sud
city: Besancon Cedex
country: France
facility: CHU Besancon Hopital Jean Minjoz
city: Chambray les Tours
country: France
facility: CHU Tours Hopital Trousseau
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Clichy cedex
country: France
facility: Hopital Beaujon
city: Nantes Cedex 1
country: France
facility: CHU Nantes Hotel Dieu
city: Nice Cedex 3
country: France
facility: CHU Nice Hopital de lArchet 2
city: Pessac
country: France
facility: Groupe Hospitalier Sud Hopital Haut Leveque USN
city: Pierre Benite cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: CHU Reims Hopital Robert Debre
city: Rennes cedex 09
country: France
facility: CHU Rennes Hopital Pontchaillou
city: Saint Etienne
country: France
facility: CHU Saint Etienne Hopital Nord
city: Strasbourg Cedex
country: France
facility: CHU Strasbourg Hopital Hautepierre
city: Toulouse Cedex 09
country: France
facility: CHU de Toulouse Hopital Rangueil
city: Vandoeuvre les Nancy
country: France
facility: Hopital de Brabois Adultes
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e V
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Halle
country: Germany
facility: Universitaetsklinikum Halle Saale
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Heidelberg
country: Germany
facility: Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein Campus Kiel
city: Leipzig
country: Germany
facility: University Leipzig
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Lueneburg
country: Germany
facility: Medizinisches Zentrum Klinikum Lueneburg
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitaetsklinikum
city: Muenster
country: Germany
facility: Gastro Campus Research
city: München
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Niedersachsen
country: Germany
facility: Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos
city: Athens
country: Greece
facility: Athens Medical Center
city: Rio Patras
country: Greece
facility: University General Hospital of Patras
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Budapest
country: Hungary
facility: Endomedix Diagnosztikai Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Dunaujvaros
country: Hungary
facility: Szent Pantaleon Korhaz Rendelointezet Dunaujvaros
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Szekszard
country: Hungary
facility: Clinfan Szolgaltato Kft
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Department of Hematology
city: Tiberias
country: Israel
facility: The Baruch Padeh MC, Poriya
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G Martino
city: Milano
country: Italy
facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: Azienda Ospedaliera Vincenzo Cervello
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Universita Campus Bio Medico di Roma
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: San Giovanni Rotondo FG
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seongnam-si,
country: Korea, Republic of
facility: CHA Bundang Medical Center CHA University
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Riga
country: Latvia
facility: Digestive Diseases Center Gastro
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Rikshospitalet
city: Kielce
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
city: Knurow
country: Poland
facility: Indywidualna Praktyka Lekarska Maciej Zymla
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes
city: Bucuresti
country: Romania
facility: S.C MedLife S.A
city: Oradea
country: Romania
facility: CMI Dr. Tirnaveanu Amelita
city: Timisoara
country: Romania
facility: Centrul de Gastroenterologie Dr. Goldis
city: Krasnoyarsk
country: Russian Federation
facility: TSBIH Territorial Clinical Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: SBHI of NN region RCH of NN n.a. N.A.Semashko
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
city: Pushkin
country: Russian Federation
facility: Evromedservis
city: Rostov-on-Don
country: Russian Federation
facility: SEIHPE Rostov State Medical University of MoH of RF
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH City Hospital # 26
city: Samara
country: Russian Federation
facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
city: Belgrade
country: Serbia
facility: Clinical Center Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta
city: Bardejov
country: Slovakia
facility: Alian s.r.o.
city: Malacky
country: Slovakia
facility: Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Nitra
country: Slovakia
facility: KM Management, spol. s r.o.
city: Presov
country: Slovakia
facility: GASTRO I., s.r.o.
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Tauli
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus AB
city: Bern
country: Switzerland
facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Yeditepe University Medical School Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty Hospital
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
city: Chernivtsi
country: Ukraine
facility: RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
city: Kharkiv
country: Ukraine
facility: CI of PH Kharkiv CCH #2
city: Kirovohrad
country: Ukraine
facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
city: Kyiv
country: Ukraine
facility: Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #1
city: Kyiv
country: Ukraine
facility: SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
city: Odessa
country: Ukraine
facility: CI Odesa Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Ternopil City Communal Emergency Medical Care Hospital
city: Zaporozhje
country: Ukraine
facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital Wonford
city: Glasgow, Scotland
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: St Marys Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Queens Medical Centre
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
Study officials:
affiliation: Celgene
name: Guillermo Rossiter, MD
role: STUDY_DIRECTOR
References: