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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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

Key facts

Study ID

NCT00295165

Run by

Genzyme, a Sanofi Company

People needed

33

Starts

2006-01-01

Expected to finish

2006-10-01

Last updated by the study team

2013-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Cryptosporidium spec.
• Any of the following laboratory abnormalities:
• Serum creatinine >/= 2.0 mg/dL
• Alkaline phosphatase (AP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >/=; 2 x the upper limit of normal
• Hemoglobin (Hgb) < 8.0 g/dL
• Absolute neutrophil count (ANC) </= 1,000 cells/µL or > cells 20,000/µL
• Planned in-patient hospitalization during the study
• Presence or history of cancer of any type (except treated basal cell carcinoma) or definite dysplasia of the colon within the last 5 years
• Use of any of the following medications during the specified period of time prior to receiving the first dose of study drug:
• At any time:

Where it is running

• Study site — Orange, California, United States
• Study site — San Francisco, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Boca Raton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Lutherville, Maryland, United States
• Study site — Towson, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Chesterfield, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Plymouth, Minnesota, United States
• Study site — Mexico, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Florham Park, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Great Neck, New York, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.