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

Sponsor

Celgene Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00446433

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Study Start Date :

Mar 1, 2002

Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 < 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:

azathioprine (AZA)
6-mercaptopurine (6 MP)
methotrexate

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

Subjects must be able to adhere to the study visit schedule and other protocol requirements.
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.
The subject must be at least 25 kg (55 lbs).

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.
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.
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).
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.

Stool examination positive for enteric pathogens (including Clostridium difficile),pathogenic ova, or parasites.
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.

Subjects with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
Dysplasia (low-grade or high-grade) of the colon/small bowel within the last 5 years prior to screening.
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.
History of alcohol or other drug abuse within 1 year of randomization, or any conditions associated with poor compliance.
Subjects in whom multiple venipunctures are not feasible due to poor tolerability or lack of easy access.
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

Locations

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

Sponsors and Collaborators

Celgene Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00446433

Other Study ID Numbers:

CC-5013-CD-001

First Posted:

Mar 12, 2007

Last Update Posted:

Dec 1, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Crohn Disease

Lenalidomide

Study Results

No Results Posted as of Dec 1, 2016