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

NCT00295165 | Terminated Phase 3

• 3 other identifiers: 31018791494NOVEL8
• Study Type: interventional
• Target: 33
• Locations: 11 countries
• Sites: 111

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

Outcome Measures

Primary Outcomes (1)

• To induce clinical remission and/or clinical response following 8 weeks of treatment

  8 weeks

Secondary Outcomes (2)

• To assess the safety profile of sargramostim (including development of antibodies against sargramostim)

  During study treatment

• To assess quality of life (QoL)

  During study treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Sargramostim (Leukine)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sargramostim (Leukine) DRUG

Sargramostim 6 mcg/kg subcutaneously once daily

Also known as: BAY86-5326

Arm 1

Placebo DRUG

Placebo subcutaneously once daily

Arm 2

Eligibility Criteria

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

You may qualify if:

• Written informed consent
• Male or female, age \>/= 18 years
• Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
• Moderately to severely active Crohn's disease at time of screening (i.e., CDAI greater than or equal to 220 and less than or equal to 475 points)
• If under treatment for Crohn's disease, medication must be stable for at least 4 weeks prior to receiving the first dose of study drug. The following therapies are allowed:
• Oral therapy with salicylates (mesalamine, sulfasalazine, olsalazine, or balsalazide) for Crohn's disease
• Antibiotics or probiotics for Crohn's disease
• Topical rectal therapy with mesalamine
• Females of child-bearing potential:
• Negative pregnancy test within 72 hours prior to receiving the first dose of study drug
• Sexually-active males and females of child-bearing potential:
• Agreement to use adequate method of contraception throughout the study
• Ability to self-inject study drug or availability of a designee who can do so

You may not qualify if:

• Pregnancy or breast-feeding
• Colostomy or ileostomy
• Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
• GI surgery within 6 months prior to receiving the first dose of study drug
• Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
• Positive stool test results for any of the following:
• Bacteria:
• Salmonella spec.
• Shigella spec.
• Campylobacter spec.
• Bacterial toxin:
• Clostridium difficile
• Ova and parasites:
• Amoeba spec.
• Giardia spec.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (111)

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Huntsville, Alabama, 35801, United States

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Orange, California, 92868, United States

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San Francisco, California, 94117, United States

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Lakewood, Colorado, 80215, United States

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Littleton, Colorado, 80120, United States

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Washington D.C., District of Columbia, 20007-2197, United States

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Boca Raton, Florida, 33486, United States

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Gainesville, Florida, 32610-0254, United States

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Atlanta, Georgia, 30342, United States

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Indianapolis, Indiana, 46202, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Hagerstown, Maryland, 21740, United States

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Lutherville, Maryland, 21093, United States

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Towson, Maryland, 21204, United States

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Ann Arbor, Michigan, 48109-0330, United States

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Chesterfield, Michigan, 48047, United States

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Troy, Michigan, 48098, United States

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Plymouth, Minnesota, 55446, United States

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Mexico, Missouri, 65265, United States

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St Louis, Missouri, 63110, United States

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Lincoln, Nebraska, 68503, United States

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Florham Park, New Jersey, 07932, United States

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New Brunswick, New Jersey, 08901, United States

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Great Neck, New York, 11021, United States

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Mineola, New York, 11501-3987, United States

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New York, New York, 10028, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28207, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27157, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44195, United States

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Dayton, Ohio, 45440, United States

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Oklahoma City, Oklahoma, 73104, United States

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Tulsa, Oklahoma, 74104, United States

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Sayre, Pennsylvania, 18840, United States

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Columbia, South Carolina, 29203, United States

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San Antonio, Texas, 78229, United States

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Charlottesville, Virginia, 22908, United States

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Chesapeake, Virginia, 23320, United States

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Christiansburg, Virginia, 24073, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23249-0002, United States

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Seattle, Washington, 98195, United States

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Wenatchee, Washington, 98801, United States

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Liverpool, New South Wales, 2170, Australia

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Caboolture, Queensland, Australia

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Adelaide, South Australia, 5000, Australia

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Frankston, Victoria, 3199, Australia

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Melbourne, Victoria, 3084, Australia

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Brisbane, QLD 4000, Australia

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Hamilton, 3204, Australia

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Sydney, Australia

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Blumenau, Santa Catarina, 89010-205, Brazil

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Florianópolis, Santa Catarina, 88020-210, Brazil

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Botucatu, São Paulo, 18618-970, Brazil

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São Paulo, São Paulo, 0122-1020, Brazil

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São Paulo, São Paulo, 04023-900, Brazil

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Santos, 11075-900, Brazil

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Sofia, 1233, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Varna, 9010, Bulgaria

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Abbotsford, British Columbia, V2S 3N5, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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Saint John, New Brunswick, E2K 1J5, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Guelph, Ontario, N1H 3R3, Canada

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Kingston, Ontario, K7L 5G2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Montreal, Quebec, H3H 1V4, Canada

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Québec, Quebec, G1R 2J6, Canada

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Saint-Charles-Borromée, Quebec, J6E 2C3, Canada

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Haifa, Israel, 31048, Israel

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Ẕerifin, Israel, 70300, Israel

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Jerusalem, 91120, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64299, Israel

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Auckland, 0622, New Zealand

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Dunedin, 9016, New Zealand

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Hamilton, 3204, New Zealand

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Tauranga, New Zealand

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Bucharest, 011025, Romania

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Bucharest, Romania

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Craiova, 200670, Romania

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Kazan', 420011, Russia

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Krasnodar, 350086, Russia

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Moskva, 119992, Russia

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Saint Petersburg, 194017, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 197110, Russia

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Saint Petersburg, Russia

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Port Elizabeth, Eastern Cape, 6057, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Cape Town, Western Cape, 7463, South Africa

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Cape Town, Western Cape, 7530, South Africa

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Cape Town, Western Cape, 7708, South Africa

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Cape Town, Western Cape, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Durban, 4001, South Africa

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Durban, South Africa

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Dnipro, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, 61039, Ukraine

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Kiev, Ukraine

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Lviv, 79013, Ukraine

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Zaporizhzhya, Ukraine

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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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 23, 2006
• Study Start: January 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

CA (10); ZA (11); RU (7); BU (4); NZ (4); RO (3); IL (5); UA (6); BR (6); AU (8); US (47)