Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

286

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

June 30, 2006

Study Completion Date

June 30, 2006

Conditions
Crohn Disease
Interventions
DRUG

Sargramostim (Leukine)

6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks

DRUG

Placebo

Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks

Trial Locations (70)

1011

Lausanne

1309

Milford

2050

Sydney

2139

Concord

2200

Sydney

2305

New Lambton Heights

2605

Garran

2751

Penrith

3010

Bern

3050

Parkville

3065

Melbourne

3128

Melbourne

3181

Prahran

3199

Frankston

3204

Hamilton

3350

Ballarat

4029

Brisbane

4031

Basel

4101

Brisbane

5043

Adelaide

6160

Fremantle

7250

Launceston

8011

Christchurch

26014

Vinnitsa

49044

Lviv

61001

Kharkiv

83017

Donetsk

105203

Moskva

123154

Moscow

127015

Moskva

129110

Moscow

398055

Lipetsk

400107

Volgograd

443023

Samara

40110060

Salvador

C1118AAT

Buenos Aires

C1264AAA

Buenos Aires

80060-900

Curitiba

21949 900

Rio de Janeiro

Unknown

Porto Alegre

05403-900

São Paulo

05651-901

São Paulo

T5H 4B9

Edmonton

T6G 2B7

Edmonton

V1Y 2H4

Kelowna

V5Z 1H2

Vancouver

V6Z 2K5

Vancouver

V8R 6T9

Victoria

R3A 1R9

Winnipeg

L8N 3Z5

Hamilton

N6A 5A5

London

M3N 2V7

Toronto

M5G 1X5

Toronto

N9A 1L9

Windsor

H3A 1A1

Montreal

H3G 1A4

Montreal

H3T 1E2

Montreal

G1S 4L8

Québec

J1G 2E9

Sherbrooke

03049

Kiev

BS2 8HW

Bristol

W12 0HS

London

M6 8HD

Salford

EH4 2XU

Edinburgh

L7 8XP

Liverpool

HA1 3UJ

Harrow

CF14 4XW

Cardiff

NE1 4LP

Newcastle upon Tyne

WC1E 6AU

London

S10 2JF

Sheffield

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00206674 - Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | Biotech Hunter | Biotech Hunter