A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Psoriatic Arthritis Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908202
• Other study ID #: IM011-054
• Secondary ID: 2020-005097-10U1
• Status: Recruiting
• Phase: Phase 3
• Start date: July 13, 2021
• Est. completion date: May 12, 2027

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: May 12, 2027
• Est. primary completion date: September 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
• Meets the Classification Criteria for Psoriatic Arthritis at Screening.
• Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.
• Active arthritis as shown by = 3 swollen joints and = 3 tender joints at Screening and day 1.
• Participant has high sensitivity C-reactive protein (hsCRP) = 3 mg/L at Screening.
• = 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
• Must have completed the week 52 treatment for the optional open-label long-term extension period. Exclusion Criteria
• Nonplaque psoriasis at screening or day 1.
• Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
• History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
• Active fibromyalgia.
• Received an approved or investigational biologic therapy for the treatment of PsA or PsO.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatic Diseases

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Consultorios Reumatológicos Pampa	Buenos Aires
Argentina	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich	Buenos Aires
Argentina	Local Institution - 0048	Buenos Aires
Argentina	Clinica Adventista Belgrano	Caba	Ciudad Autónoma De Buenos Aires
Argentina	DOM Centro de Reumatología	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0165	Cordoba
Argentina	Hospital Cordoba	Córdoba	Cordoba
Argentina	Local Institution	DQG	Distrito Federal
Argentina	Local Institution - 0054	La Plata	Buenos Aires
Argentina	Instituto de Reumatología	Mendoza
Argentina	CER medical Institute	Quilmes	Ciudad Autónoma De Buenos Aires
Argentina	Instituto CAICI SRL	Rosario	Santa Fe
Argentina	Centro Medico Privado de Reumatologia	San Miguel De Tucuman	Tucuman
Australia	Optimus Clinical Research Pty Ltd	Botany	New South Wales
Australia	Emeritus Research	Camberwell	Victoria
Australia	Local Institution	Clayton	Victoria
Australia	Local Institution - 0211	Hobart	Tasmania
Australia	Paratus Clinical Research Woden	Phillip	Australian Capital Territory
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Brazil	Centro de Estudos em Terapias Inovadoras	Curitiba	Paraná
Brazil	Edumed - Educação em Saúde S/S Ltda.	Curitiba	Paraná
Brazil	Cmip-Centro Mineiro de Pesquisa	Juiz de Fora	Minas Gerais
Brazil	LMK Serviços Médicos S/S-Reumacenter	Porto Alegre	RIO Grande DO SUL
Brazil	Serviços Especializados em Reumatologia	Salvador	Bahia
Brazil	Local Institution	Sao Paulo
Brazil	CEDOES	Vitória	Espirito Santo
Bulgaria	Local Institution - 0253	Burgas
Bulgaria	Medical Center Artmed	Plovdiv
Bulgaria	UMBAL Plovdiv AD	Plovdiv
Bulgaria	Unimed medical Centre - Plovdiv	Plovdiv
Bulgaria	University Hospital Kaspela Clinic of Rheumatology	Plovdiv
Bulgaria	University Multiprofile Hospital for Active Treatment "Pulmed"	Plovdiv
Bulgaria	ACIBADEM City Clinic Diagnostic-Consultative Center	Sofia
Bulgaria	Diagnostic Consultative Centre (DCC) - Fo?us 5	Sofia
Bulgaria	Diagnostic Consulting Centre XVII	Sofia
Bulgaria	Diagnostic and Consultative Center Equita	Varna
Chile	Centro Estudios Reumatologicos	Santiago	Metropolitana
Chile	Centro Internacional de Estudios Clinicos (CIEC)	Santiago	Región Metropolitana De Santiago
Chile	Centro Internacional de Estudios Clinicos (CIEC)	Santiago	Región Metropolitana De Santiago
Chile	Clinica Dermacross	Santiago	Metropolitana
Chile	Estudios Clinicos CTR	Santiago	Región Metropolitana De Santiago
Chile	Prosalud	Santiago	Región Metropolitana De Santiago
Chile	Oncocentro Apys	Viña del Mar	Valparaíso
China	Beijing Hospital-Rheumatology and Immunology Department	Beijing	Beijing
China	The Second Affiliated Hospital Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital Of Dalian Medical University	DaLian	Liaoning
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Anhui Provincial Hospital	Hefei	Anhui
China	Huashan Hospital Affiliated Fudan University-Rheumatology and Immunology Department	Shanghai	Shanghai
China	ShenZhen People's Hospital	Shenzhen	Guangdong
China	Zhejiang University School of Medicine - The Fourth Affiliated Hospital	Yiwu	Zhejiang
Colombia	Centro de Reumatologia y Ortopedia	Barranquilla
Colombia	Fundacion Santa Fe De Bogota	Bogota
Colombia	Solano & Terront Servicios Medicos - UNIENDO	Bogotá	Cundinamarca
Colombia	Servimed EU	Bucaramanga	Santander
Colombia	Centro de Estudios de Reumatología y Dermatología SAS	Cali
Colombia	Hospital Pablo Tobon Uribe	Medellin
Colombia	Healthy Medical Center S.A.S	Zipaquira
Czechia	Artroscan, s.r.o.	Ostrava
Czechia	ARTHROHELP s.r.o.	Pardubice
Czechia	Local Institution	Pardubice
Czechia	Fakultni nemocnice v Motole	Praha	Praha 5
Czechia	Pratia Prague s.r.o.	Praha
Czechia	Revmatologicky ustav-Rheumatology	Praha 2
Czechia	Medical Plus	Uherske Hradiste	Zlínský Kraj
Czechia	Local Institution - 0202	Zlín	Zlínský Kraj
Finland	Meilahti Triangle Hospital	Helsinki
Finland	Satucon oy	Kuopio
Finland	Turku University Hospital-Center for Rheumatology and Clinical Immunology	Turku
France	CHRU Troussau-Rhumatologie	Chambray Les Tours
France	CHU Montpellier Lapeyronie Hospital-Rhumatologie	Montpellier
France	Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière-RHEUMATOLOGIE	Paris
Hungary	Clinexpert Kft.-Clinexpert Budapest	Budapest
Hungary	Local Institution - 0142	Budapest
Hungary	Obudai Egeszsegugyi Centrum	Budapest
Hungary	Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.	Budapest
Hungary	Revita Clinic	Budapest
Hungary	Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház	Gyula	Békés
Hungary	CMed Rehabilitacios es Diagnosztikai Kozpont	Székesfehérvár	Fejér
Hungary	Local Institution - 0068	Zalaegerszeg
Ireland	Connolly Hospital-Rheumatology	Dublin
Ireland	St. Vincent's University Hospital-Rheumatology	Dublin
Ireland	Merlin Park Hospital-Rheumatology	Galway
Ireland	Our Ladys Hospital - Leitrim	Manorhamilton	Leitrim
Italy	Ospedale San Martino-Dept. of Internal Medicine (DIMI)	Genova
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Local Institution - 0096	Udine
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma	Verona
Mexico	Investigacion y Biomedicina de Chihuahua	Chihuahua
Mexico	Centro de Investigación de Enfermedades Autoinmunes (CINEA)	Guadalajara	Jalisco
Mexico	Medical Care and Research SA de CV	Merida	Yucatán
Mexico	Kohler and Milstein Research S.A. de C.V.	Mérida	Yucatán
Mexico	Hospital General de Mexico	México	Distrito Federal
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City	Distrito Federal
Mexico	Local Institution - 0227	Mexico City	Distrito Federal
Mexico	Clinical Research Institute Saltillo	Saltillo	Coahuila
Mexico	Centro De Atencion E Invest Cardiovascular Del Potosi	San Luis Potosí	SAN LUIS Potosi
Mexico	Sociedad de Metabolismo y Corazon	Veracruz
Poland	Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik	Bialystok
Poland	Centrum Medyczne SYNEXUS	Czestochowa	Slaskie
Poland	NSZOZ Unica CR	Dabrówka	Wielkopolskie
Poland	Synexus Polska Gdansku	Gdansk	Pomorskie
Poland	Centrum Medyczne Pratia Gdynia	Gdynia	Pomorskie
Poland	Synexus Polska - Katowicach	Katowice	Slaskie
Poland	Krakowskie Centrum Medyczne	Krakow
Poland	Centrum Medyczne ALL-MED-Centrum Medyczne ALL-MED	Kraków
Poland	Malopolskie Badania Kliniczne-Main Site	Kraków
Poland	Maopolskie Centrum Kliniczne	Kraków	Malopolskie
Poland	SOMED CR	Lodz	Lódzkie
Poland	Zespól Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda	Lublin	Lubelskie
Poland	Mak-Med Clinic Sp. Z O.O.	Nadarzyn	Mazowieckie
Poland	Local Institution - 0206	Nowy Targ	Malopolskie
Poland	ETYKA Osrodek Badan Klinicznych	Olsztyn
Poland	Medyczne Centrum Hetmanska	Poznan
Poland	Reumedika Wieslawa Porawska Lukasz Porawski Spólka Cywilna	Poznan
Poland	Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan	Wielkopolskie
Poland	Lubelskie Centrum Diagnostyczne	Swidnik	Lubelskie
Poland	Centrum Medyczne Reuma Park	Warszawa	Mazowieckie
Poland	Futuremeds Targowek	Warszawa
Poland	MICS Centrum Medyczne Warszawa	Warszawa
Poland	Rheuma Medicus Sp. z o.o.	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa	Mazowieckie
Poland	Centrum Medyczne K2J2	Wolomin	Mazowieckie
Poland	Local Institution - 0210	Wroclaw
Poland	Local Institution - 0251	Wroclaw
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw	Dolnoslaskie
Romania	C.M.D.T.A. Neomed-Reumatologie	Brasov
Romania	CCBR Clinical Research	Bucharest
Romania	Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului	Bucharest
Romania	Local Institution - 0167	Bucharest
Romania	Spital Clinic Sf. Maria	Bucharest	Bucure?ti
Romania	Delta Health Care	Bucuresti
Romania	Local Institution - 0266	Bucuresti	Bucure?ti
Romania	Local Institution - 0011	Cluj Napoca
Romania	Local Institution - 0258	Craiova
Romania	Local Institution - 0265	Ia?i
Romania	RK Medcenter	Ia?i
Romania	Centrul Medical Arcadia Nicolina	Iasi
Romania	SC MEDAUDIO-OPTICA SRL-Rheumatology	Râmnicu Vâlcea
Romania	Centrul de Kinetoterapie si Masaj Banat SRL	Timisoara
Russian Federation	Local Institution	Chelyabinsk
Russian Federation	Local Institution	Kazan
Russian Federation	Local Institution	Kemerovo
Russian Federation	Local Institution	Korolev
Russian Federation	Local Institution	Korolev
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Ryazan
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	Yaroslavl
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia	A Coruña
Spain	Hospital Universitario Reina Sofia-REUMATOLOGIA	Cordoba
Spain	Hospital Universitario La Paz-reumatología	Madrid
Spain	Hospital Universitari Parc Tauli-Rheumatology Clinical trial department	Sabadell
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung City
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	Local Institution - 0121	Tainan City
Taiwan	Taipei Medical University Hospital-Division of General Medicine	Taipei City
Taiwan	Chang Gung Medical Foundation-Linkou Branch-Department of Rheumatology, Allergy and Immunology	Taoyuan
United Kingdom	Princess Alexandra Hospital-Rheumatology	Harlow
United Kingdom	Southampton General Hospital	Southampton	Hampshire
United Kingdom	Haywood Community Hospital	Stoke-on-Trent
United States	Arthritis and Rheumatology Research Institute	Allen	Texas
United States	Amarillo Center for Clinical Research-Research	Amarillo	Texas
United States	Rheumatology and Pulmonary Clinic	Beckley	West Virginia
United States	St. Luke's Clinic	Boise	Idaho
United States	Sound Clinical Research, LLC	Bothell	Washington
United States	Local Institution - 0080	Chicago	Illinois
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center-Dermatology	Cleveland	Ohio
United States	Good Samaritan Hospital Corvallis	Corvallis	Oregon
United States	Local Institution - 0032	Dallas	Texas
United States	Denver Arthritis Clinic	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Local Institution - 0168	Fontana	California
United States	Local Institution	Fountain Valley	California
United States	Providence Medical Foundation	Fullerton	California
United States	Arthritis Center of North Georgia	Gainesville	Georgia
United States	Arizona Arthritis and Rheumatology Associates	Gilbert	Arizona
United States	Local Institution - 0175	Greenville	South Carolina
United States	Klein and Associates, M.D., P.A.	Hagerstown	Maryland
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Arthritis and Rheumatism Associates (ARA) - Jonesboro	Jonesboro	Arkansas
United States	Logan Health Research	Kalispell	Montana
United States	Arthritis Center of Lexington-Bluegrass Community Research, Inc.	Lexington	Kentucky
United States	Life Clinical Trials	Margate	Florida
United States	San Marcus Research Clinic, Inc.	Miami Lakes	Florida
United States	Paramount Medical Research and Consulting, Llc	Middleburg Heights	Ohio
United States	Local Institution - 0182	Oklahoma City	Oklahoma
United States	Greater Chicago Specialty Physicians - Orland Park	Orland Park	Illinois
United States	Local Institution	Palm Desert	California
United States	Local Institution - 0179	Perrysburg	Ohio
United States	Local Institution - 0038	Sacramento	California
United States	Greater Chicago Specialty Physicians	Schaumburg	Illinois
United States	Clinvest Research LLC	Springfield	Missouri
United States	Cohen Medical Centers	Thousand Oaks	California
United States	Local Institution	Toms River	New Jersey
United States	Arthritis, Rheumatic and Bone Disease Associates, Affiliate of Trabecular Medical Group, LLC	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Chile,  China,  Colombia,  Czechia,  Finland,  France,  Hungary,  Ireland,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response		At week 16
Secondary	Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score		At week 16
Secondary	Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score		At week 16
Secondary	Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response		At week 16
Secondary	Change from baseline in the Short Form-36 Physical Component Survey (SF-36 PCS) score		At week 16
Secondary	Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)		At week 16
Secondary	Proportion of participants meeting achievement of Minimal Disease Activity (MDA)		At week 16
Secondary	Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score		At week 16
Secondary	Proportion of participants meeting dactylitis resolution at week 16 among the participants with dactylitis at baseline		At week 16
Secondary	Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score		At week 16
Secondary	Proportion of participants meeting ACR 20 response		Up to 16 weeks
Secondary	Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response		Up to 16 weeks
Secondary	Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response		Up to 16 weeks
Secondary	Change from baseline in HAQ-DI score		Up to 16 weeks
Secondary	Proportion of participants who achieve a clinically meaningful improvement (= 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score = 0.35 at baseline		Up to 16 weeks
Secondary	Proportion of participants with achievement of PASI 75 response		Up to 16 weeks
Secondary	Proportion of participants with achievement of PASI 90 response		Up to 16 weeks
Secondary	Proportion of participants with achievement of PASI 100 response		Up to 16 weeks
Secondary	Change from baseline in the SF-36 PCS score		Up to 16 weeks
Secondary	Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI		Up to 16 weeeks
Secondary	Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of MDA		Up to 16 weeks
Secondary	Change from baseline in SF-36 Mental Component Summary (MCS) score		Up to 16 weeks
Secondary	Change from baseline in FACIT-Fatigue score		Up to 16 weeks
Secondary	Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline		Up to 16 weeks
Secondary	Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score		Up to 16 weeks
Secondary	Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score		Up to 16 weeks
Secondary	Proportion of participants with achievement of DAPSA low disease activity response		Up to 16 weeks
Secondary	Proportion of participants with achievement of DAPSA disease remission		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of = 3		Up to 16 weeks
Secondary	Change from baseline in DAS28-CRP score		Up to 16 weeks
Secondary	Proportion of participants with achievement of a DAS28-CRP low disease activity response		Up to 16 weeks
Secondary	Proportion of participants with achievement of a DAS28-CRP disease remission		Up to 16 weeks
Secondary	Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)		Up to 16 weeks
Secondary	Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score		Up to 16 weeks
Secondary	Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0		At week 16
Secondary	Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0.5		At week 16
Secondary	Proportion of participants meeting achievement of total PsA-modified SvdH score of = smallest detectable change (SDC)		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0.5		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = SDC		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN) score change of = 0		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = 0.5		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = SDC		At week 16
Secondary	Change in PsA-modified SvdH erosion score from baseline		At week 16
Secondary	Change in PsA-modified SvdH JSN score		At week 16
Secondary	Change from baseline in domain scales scores of SF-36		Up to 16 weeks
Secondary	Change from baseline in PCS score of SF-36		Up to 16 weeks
Secondary	Change from baseline in MCS score of SF-36		Up to 16 weeks
Secondary	Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire		Up to 16 weeks
Secondary	Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores		Up to 16 weeks
Secondary	Change from baseline in the 5-level EQ-5D-5L utility score subcomponents		Up to 16 weeks
Secondary	Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)		Up to 16 weeks
Secondary	Incidence of adverse events (AEs)		Up to 156 weeks
Secondary	Incidence of serious adverse events (SAEs)		Up to 156 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting