A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease

NCT00446433 | Completed Phase 2

• 1 other identifier: CC-5013-CD-001
• Study Type: interventional
• Target: 90
• Locations: 4 countries
• Sites: 20

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

Conditions

Crohn's Disease

Interventions

CC-5013 DRUG

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 400.
• 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®)
• sulfasalazine
• oral mesalamine
• oral olsalazine
• topical rectal therapy with corticosteroids or mesalamine
• The start date of the medications listed below must be at least 3 months (12 weeks) prior to randomization, and the dose must have been unchanged for at least 4 weeks. 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 6 weeks prior to randomization. The medications are:

You may not qualify if:

• 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.
• Subjects in whom enteral nutrition with elemental or semi-elemental formula comprises more than 50% of their total daily caloric intake. For adolescents between the ages of 12-17, subjects in whom enternal nutrition with elemental or semi-elemental formula comprises more the 75% of their total daily caloric intake.
• Chronic hepatitis B and C
• Documented HIV infection, ARC (AIDS related complex), AIDS, or immune deficiency.
• Stool examination positive for enteric pathogens (including Clostridium difficile),pathogenic ova, or parasites.
• Concomitant or recent medication use as follows:

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (20)

Advanced Clinical Therapeutics

Tucson, Arizona, 85712, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Washington Hospital Center Physicians Office Building

Washington D.C., District of Columbia, 20010, United States

Location

Springfield Clinic

Springfield, Illinois, 62794-9248, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Hopital Saint Louis

Paris, 75010, France

Location

Rambam Hospital

Haifa, Israel

Location

Department of Medicine A, Liver & Gastroenterology Units

Jerusalem, 91120, Israel

Location

Department of Gastroenterology and Hepatology

Tel Litwinsky, 52621, Israel

Location

Department of Gastroenterology

Dartford, Kent, DA2 8DA, United Kingdom

Location

Department of Gastroenterology

Bristol, BS2 8HW, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 2QQ, United Kingdom

Location

Department of Medicine

Cardiff, CF 14 4XW, United Kingdom

Location

Department of Gastroenterology

London, NW3 2QG, United Kingdom

Location

Department of Gastroenterology

London, W12 0HS, United Kingdom

Location

Department of Gastroenterology

London, W1N 8AA, United Kingdom

Location

Department of Gastroenterology

Manchester, M13 9WL, United Kingdom

Location

St. Mark's Hospital

Middlesex, HA 1 3UI, United Kingdom

Location

Department of Gastroentroerology

Newcastle, NE1 4LP, United Kingdom

Location

Unknown Facility

Nottingham, United Kingdom

Location

Related Publications (1)

• Mansfield JC, Parkes M, Hawthorne AB, Forbes A, Probert CS, Perowne RC, Cooper A, Zeldis JB, Manning DC, Hawkey CJ. A randomized, double-blind, placebo-controlled trial of lenalidomide in the treatment of moderately severe active Crohn's disease. Aliment Pharmacol Ther. 2007 Aug 1;26(3):421-30. doi: 10.1111/j.1365-2036.2007.03385.x.

  PMID: 17635377 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 12, 2007
• Study Start: March 1, 2002
• Study Completion: December 1, 2003
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

GB (11); IL (3); US (5); FR (1)