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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00446433
First received: March 7, 2007
Last updated: April 3, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Crohn's Disease
Drug: CC-5013
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Estimated Enrollment: 90
Study Start Date: March 2002
Estimated Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects > 12 and < 75 years of age.
  2. 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.
  3. Negative pregnancy test for females of child bearing potential.
  4. A history of Crohn’s Disease (CD) of greater than 1-year duration diagnosed and documented by standard clinical, radiographic, endoscopic, histopathological criteria.
  5. Signs and symptoms of moderately severe CD as defined by a Crohn’s Disease Activity Index (CDAI) score of > 220 and < 400.
  6. Normal thyroid function as documented by normal TSH (thyroid stimulating hormone).
  7. 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
  8. 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:

    • azathioprine (AZA)
    • 6-mercaptopurine (6 MP)
    • methotrexate
  9. Subject’s screening laboratory test results must meet the following criteria:

    • hemoglobin > 8.5 g/dL.
    • white blood cells (WBC) > 3.5 x 109 / L.
    • neutrophils > 1.5 x 109/L and lymphocytes >0.5 x 109/L.
    • platelets > 100 x 109 / L.
    • bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) , and alkaline phosphate levels must not be above two times the upper limit of the normal range.
    • serum albumin > 3.2 mg /dL for adults (18-75) and serum albumin > 2.8 mg/dL for adolescents between the ages of 12-17.
    • serum creatinine < 2.0 mg/dL
  10. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
  11. The subject must understand and voluntarily sign an informed consent document. Adolescent subjects under 18 years of age must have parent/guardian consent as evidenced by a signature on the consent form as well as their own assent, as evidenced by signature on the consent form.
  12. The subject must be at least 25 kg (55 lbs).

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Predisposition to cardiac arrhythmias and history of clinically significant cardiac disease.
  3. Diagnosis of ulcerative colitis.
  4. CD that is limited to the stomach and proximal small intestine.
  5. Known severe fixed symptomatic stenosis or stricture of the small or large intestine.
  6. 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.
  7. Subjects who have undergone a proctocolectomy or total colectomy with ileorectal anastomosis; segmental colectomy is permitted.
  8. Colostomy or ileostomy.
  9. 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.
  10. Subjects requiring intravenous nutritional support with total parenteral nutrition (TPN)/partial parenteral nutrition (PPN) that provides > 50 % of total daily caloric intake.
  11. 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.
  12. Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine (including thyroid as documented by an abnormal TSH), pulmonary, cardiac, neurological, or cerebral disease, including the following specific exclusions: uncontrolled diabetes, unstable ischemic heart disease, uncontrolled or recent seizures, autoimmune diseases not related to inflammatory bowel diseases, chronic respiratory insufficiency, or recent cerebral vascular accident (within 2 months of randomization).
  13. Serious infections or history of opportunistic infections; less serious infections within 3 months of randomization, such as acute upper respiratory tract infections (colds) or uncomplicated urinary tract infection are permitted at the discretion of the Investigator. The following are specific exclusions:

    • Chronic hepatitis B and C
    • Documented HIV infection, ARC (AIDS related complex), AIDS, or immune deficiency.
  14. Stool examination positive for enteric pathogens (including Clostridium difficile),pathogenic ova, or parasites.
  15. Concomitant or recent medication use as follows:

    • Treatment with any other therapeutic agent targeted at reducing TNF-a, e.g., CC-1088, thalidomide, cyclosporine, or pentoxifylline within 4 weeks of randomization, and mycophenolate (Cellcept), infliximab (Remicadeä), Enbrelä, or FK506 (Tacrolimus) within 8 weeks of randomization
    • Treatment with interleukin-2 or –10 or other immunomodifier agent within 24 weeks of randomization.
    • Requirement of systemic corticosteroid therapy for other disease(s), e.g., asthma. Inhaled steroids for treating asthma are acceptable for this protocol.
    • Subjects receiving anticoagulant therapy (other than a total daily aspirin dose of 325 mg or less).
    • Subjects having received non CD-directed antibiotic therapy within 2 weeks of randomization. CD-directed antibiotic therapy, for example with ciprofloxacin or metronidazole, is acceptable provided the dose has been stable for the 2 weeks prior to randomization.
    • Subjects who have received an investigational drug within 30 days of randomization.
  16. Subjects with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
  17. Dysplasia (low-grade or high-grade) of the colon/small bowel within the last 5 years prior to screening.
  18. Subjects who, in the judgment of the Investigator, are unwilling or unable to comply with all the protocol-related assessments and procedures, including completion of a daily diary.
  19. History of alcohol or other drug abuse within 1 year of randomization, or any conditions associated with poor compliance.
  20. Subjects in whom multiple venipunctures are not feasible due to poor tolerability or lack of easy access.
  21. Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446433

Locations
United States, Arizona
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, District of Columbia
Washington Hospital Center Physicians Office Building
Washington, District of Columbia, United States, 20010
United States, Illinois
Springfield Clinic
Springfield, Illinois, United States, 62794-9248
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
France
Hopital Saint Louis
Paris, France, 75010
Israel
Rambam Hospital
Haifa, Israel
Department of Medicine A, Liver & Gastroenterology Units
Jerusalem, Israel, 91120
Department of Gastroenterology and Hepatology
Tel-Hashomer, Israel, 52621
United Kingdom
Department of Gastroenterology
Dartford, Kent, United Kingdom, DA2 8DA
Department of Gastroenterology
Bristol, United Kingdom, BS2 8HW
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 2QQ
Department of Medicine
Cardiff, United Kingdom, CF 14 4XW
Department of Gastroenterology
London, United Kingdom, W1N 8AA
Department of Gastroenterology
London, United Kingdom, W12 0HS
Department of Gastroenterology
London, United Kingdom, NW3 2QG
Department of Gastroenterology
Manchester, United Kingdom, M13 9WL
St. Mark's Hospital
Middlesex, United Kingdom, HA 1 3UI
Department of Gastroentroerology
Newcastle, United Kingdom, NE1 4LP
Nottingham, United Kingdom
Sponsors and Collaborators
Celgene Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00446433     History of Changes
Other Study ID Numbers: CC-5013-CD-001
Study First Received: March 7, 2007
Last Updated: April 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014