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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn Disease

Intervention: Sargramostim (Leukine) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

Clinical Details

Official title: Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Induction of clinical response and/or remission as defined by decrease in CDAI score

Secondary outcome:

Time and duration to response/remission

QoL (different methods)

Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)

Detailed description: On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Stable but active Crohn's disease at the time of screening

- Must be able to self-inject or have another person who can help with the injection

Exclusion Criteria:

- Not have a colostomy or ileostomy

- Not be taking prohibited medications as defined in the protocol

- Not have had GI surgery or a bowel obstruction in the last 6 months or planned

surgery for the next months

- Not have ever taken this drug or drugs of similar type in the past

Locations and Contacts

Penrith 2751, Australia

Quebec G1S 4L8, Canada

Christchurch 8011, New Zealand

Hamilton 3204, New Zealand

Moscow 123154, Russian Federation

Moscow 129110, Russian Federation

Moskva 127015, Russian Federation

Volgograd 400107, Russian Federation

Basel 4031, Switzerland

Bern 3010, Switzerland

Donetsk 83017, Ukraine

Kharkiv 61001, Ukraine

Kiev 03049, Ukraine

Lviv 49044, Ukraine

Vinnitsa 26014, Ukraine

London WC1E 6AU, United Kingdom

Sheffield S10 2JF, United Kingdom

Edmonton, Alberta T5H 4B9, Canada

Edmonton, Alberta T6G 2B7, Canada

Milford, Auckland 1309, New Zealand

Garran, Australian Capital Territory 2605, Australia

Bristol, Avon BS2 8HW, United Kingdom

Salvador, Bahia 40110060, Brazil

Kelowna, British Columbia V1Y 2H4, Canada

Vancouver, British Columbia V5Z 1H2, Canada

Vancouver, British Columbia V6Z 2K5, Canada

Victoria, British Columbia V8R 6T9, Canada

Buenos Aires, Capital Federal C1118AAT, Argentina

Buenos Aires, Capital Federal C1264AAA, Argentina

London, Greater London W12 0HS, United Kingdom

Salford, Greater Manchester M6 8HD, United Kingdom

Edinburgh, Lothian EH4 2XU, United Kingdom

Winnipeg, Manitoba R3A 1R9, Canada

Liverpool, Merseyside L7 8XP, United Kingdom

Harrow, Middlesex HA1 3UJ, United Kingdom

Concord, New South Wales 2139, Australia

New Lambton Heights, New South Wales 2305, Australia

Sydney, New South Wales 2050, Australia

Sydney, New South Wales 2200, Australia

Hamilton, Ontario L8N 3Z5, Canada

London, Ontario N6A 5A5, Canada

Toronto, Ontario M3N 2V7, Canada

Toronto, Ontario M5G 1X5, Canada

Windsor, Ontario N9A 1L9, Canada

Curitiba, Parana 80060-900, Brazil

Montreal, Quebec H3A 1A1, Canada

Montreal, Quebec H3G 1A4, Canada

Montreal, Quebec H3T 1E2, Canada

Sherbrooke, Quebec J1G 2E9, Canada

Brisbane, Queensland 4029, Australia

Brisbane, Queensland 4101, Australia

Rio de Janeiro, RJ 21949 900, Brazil

Porto Alegre, RS, Brazil

Lipetsk, Russia 398055, Russian Federation

Moskva, Russia 105203, Russian Federation

Samara, Russia 443023, Russian Federation

Sao Paulo, SP 05403-900, Brazil

SĂŁo Paulo, SP 05651-901, Brazil

Adelaide, South Australia 5043, Australia

Cardiff, South Glamorgan CF14 4XW, United Kingdom

Launceston, Tasmania 7250, Australia

Newcastle Upon Tyne, Tyne and Wear NE1 4LP, United Kingdom

Ballarat, Victoria 3350, Australia

Frankston, Victoria 3199, Australia

Melbourne, Victoria 3065, Australia

Melbourne, Victoria 3128, Australia

Parkville, Victoria 3050, Australia

Prahran, Victoria 3181, Australia

Lausanne, Waadt 1011, Switzerland

Fremantle, Western Australia 6160, Australia

Additional Information

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Starting date: September 2004
Last updated: December 2, 2013

Page last updated: August 23, 2015

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