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

NCT00206674 | Completed Phase 3

• 3 other identifiers: 30838091405Novel 4
• Study Type: interventional
• Target: 286
• Locations: 9 countries
• Sites: 70

Brief Summary

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

Conditions

Crohn Disease

Keywords

Morbus Crohn; Sargramostim; Phase III; Placebo Controlled

Outcome Measures

Primary Outcomes (1)

• Induction of clinical response and/or remission as defined by decrease in CDAI score

  After 8 weeks of treatment

Secondary Outcomes (3)

• Time and duration to response/remission

  During the 8 weeks of treatment

• QoL (different methods)

  During the whole study

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

  About 20 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Sargramostim (Leukine)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sargramostim (Leukine) DRUG

6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks

Also known as: BAY86-5326

Arm 1

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (70)

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Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

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Buenos Aires, Buenos Aires F.D., C1264AAA, Argentina

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Garran, Australian Capital Territory, 2605, Australia

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Concord, New South Wales, 2139, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Sydney, New South Wales, 2050, Australia

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Sydney, New South Wales, 2200, Australia

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Brisbane, Queensland, 4029, Australia

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Brisbane, Queensland, 4101, Australia

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Adelaide, South Australia, 5043, Australia

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Launceston, Tasmania, 7250, Australia

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Ballarat, Victoria, 3350, Australia

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Frankston, Victoria, 3199, Australia

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Melbourne, Victoria, 3065, Australia

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Melbourne, Victoria, 3128, Australia

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Parkville, Victoria, 3050, Australia

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Prahran, Victoria, 3181, Australia

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Fremantle, Western Australia, 6160, Australia

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Penrith, 2751, Australia

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Salvador, Estado de Bahia, 40110060, Brazil

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Curitiba, Paraná, 80060-900, Brazil

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Rio de Janeiro, Rio de Janeiro, 21949 900, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, 05403-900, Brazil

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São Paulo, São Paulo, 05651-901, Brazil

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Edmonton, Alberta, T5H 4B9, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Kelowna, British Columbia, V1Y 2H4, Canada

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Vancouver, British Columbia, V5Z 1H2, Canada

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Vancouver, British Columbia, V6Z 2K5, Canada

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Victoria, British Columbia, V8R 6T9, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M3N 2V7, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Windsor, Ontario, N9A 1L9, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1S 4L8, Canada

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Sherbrooke, Quebec, J1G 2E9, Canada

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Milford, Auckland, 1309, New Zealand

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Christchurch, 8011, New Zealand

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Hamilton, 3204, New Zealand

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Lipetsk, Russia, 398055, Russia

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Moskva, Russia, 105203, Russia

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Samara, Russia, 443023, Russia

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Moscow, 123154, Russia

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Moscow, 129110, Russia

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Moskva, 127015, Russia

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Volgograd, 400107, Russia

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Basel, Basel, 4031, Switzerland

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Bern, Canton of Bern, 3010, Switzerland

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Lausanne, Canton of Vaud, 1011, Switzerland

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Donetsk, 83017, Ukraine

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Kharkiv, 61001, Ukraine

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Kiev, 03049, Ukraine

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Lviv, 49044, Ukraine

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Vinnitsa, 26014, Ukraine

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Bristol, Avon, BS2 8HW, United Kingdom

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London, Greater London, W12 0HS, United Kingdom

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Salford, Greater Manchester, M6 8HD, United Kingdom

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Edinburgh, Lothian, EH4 2XU, United Kingdom

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Liverpool, Merseyside, L7 8XP, United Kingdom

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Harrow, Middlesex, HA1 3UJ, United Kingdom

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Cardiff, South Glamorgan, CF14 4XW, United Kingdom

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

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London, WC1E 6AU, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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MeSH Terms

Conditions

Crohn Disease

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

BR (6); RU (7); CH (3); GB (10); CA (17); AU (17); NZ (3); UA (5); AR (2)