Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)

PHASE3CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

October 27, 2010

Primary Completion Date

January 15, 2014

Study Completion Date

February 9, 2018

Conditions
Polycythemia Vera
Interventions
DRUG

ruxolitinib tablets

Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy

OTHER

Best Available Therapy (BAT)

Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Trial Locations (102)

Unknown

Birmingham

Scottsdale

Pomona

Sacramento

San Diego

Bridgeport

New Haven

Boynton Beach

Fort Myers

Jacksonville

Winter Park

Boise

Chicago

Lafayette

Scarborough

Baltimore

Columbia

Southfield

Jefferson City

St Louis

Omaha

Morristown

Somerville

Charleston

Greenville

Nashville

Houston

Seattle

Buenos Aires

Brisbane

Parkville

Tweed Heads

Antwerp

Bruges

Brussels

Leuven

Hamilton

Montreal

Toronto

Beijing

Hangzhou

Avignon

Bayonne

Brest

Lille

Nantes

Paris

Vandœuvre-lès-Nancy

Aachen

Berlin

Bonn

Freiburg im Breisgau

Hamburg

Jena

Magdeburg

Mannheim

Minden

München

Ulm

Budapest

Kecskemét

Szeged

Szombathely

Bari

Bergamo

Bologna

Florence

Milan

Napoli

Orbassano

Pavia

Reggio Calabria

Roma

Varese

Vicenza

Chiba

Chuo-city Yamanashi

Maebashi

Nagoya-city Aichi

Osaka

Tokyo

Enschede

Rotterdam

Moscow

Saint Petersburg

Seoul

A Coruña

Barcelona

Las Palmas de Gran Canaria

Madrid

Majadahonda

Málaga

Pamplona

Salamanca

Valencia

Bangkok

Ankara

Istanbul

Izmir

Bournemouth

Cardiff

London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Incyte Corporation

INDUSTRY