A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease

Celgene Corporation14 sites in 4 countries90 target enrollmentMarch 2002

ConditionsCrohn's Disease

DrugsCC-5013

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: Celgene Corporation
Enrollment: 90
Locations: 14
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults with Moderately Severe Crohn's Disease

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

December 2003

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Celgene Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects \> 12 and \< 75 years of age.
•Adolescent and adult female subjects must be of non-childbearing potential (hysterectomy) or be using one highly effective method (e.g., IUD, hormonal contraception, tubal ligation) of birth control during the entire study. Abstinence will be considered an acceptable method of birth control for adolescent females aged 12-17 years who are not sexually active and who the investigator feels will be compliant with this requirement for the 12-week treatment period. Female subjects who are post-menopausal must have had 24 continuous months of amenorrhea.
•Negative pregnancy test for females of child bearing potential.
•A history of Crohn's Disease (CD) of greater than 1-year duration diagnosed and documented by standard clinical, radiographic, endoscopic, histopathological criteria.
•Signs and symptoms of moderately severe CD as defined by a Crohn's Disease Activity Index (CDAI) score of \> 220 and \<
•Normal thyroid function as documented by normal TSH (thyroid stimulating hormone).
•The subject's treatment for CD must be unchanged, as described below:
•The start date of the medications listed below must be at least 4 weeks prior to randomization, and the dose must have been unchanged for at least 2 weeks prior to that visit. Medication doses may be decreased but not increased throughout the study. If not currently using these agents, the stop date of any previous treatment with these agents must be at least 4 weeks prior to randomization. The medications are:
•oral or systemic corticosteroids
•metronidazole (Flagyl®)

Exclusion Criteria

•Pregnancy or lactation.
•Predisposition to cardiac arrhythmias and history of clinically significant cardiac disease.
•Diagnosis of ulcerative colitis.
•CD that is limited to the stomach and proximal small intestine.
•Known severe fixed symptomatic stenosis or stricture of the small or large intestine.
•Current evidence of bowel obstruction, or history within the 3 months preceding randomization confirmed with objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the bowel proximal to the stricture observed upon barium enema or an inability to traverse the stricture at endoscopy.
•Subjects who have undergone a proctocolectomy or total colectomy with ileorectal anastomosis; segmental colectomy is permitted.
•Colostomy or ileostomy.
•Subjects with fulminant disease requiring parenteral steroid treatment, hospitalization, or felt to be in imminent need of surgery, i.e. toxic megacolon, active gastrointestinal bleeding, history of significant ulcer disease and/or esophagitis, peritonitis, intestinal obstruction, perforation, or intra-abdominal abscess requiring surgical drainage.
•Subjects requiring intravenous nutritional support with total parenteral nutrition (TPN)/partial parenteral nutrition (PPN) that provides \> 50 % of total daily caloric intake.