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Crohn's DiseasePhase 2NCT00446433

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

A Phase 2 study testing CC-5013 in people with Crohn's Disease, run by Celgene Corporation at 20 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
CC-5013
How many people
90 participants
Where
20 sitesin 4 countries
Study dates
Mar 2002to Dec 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

United Kingdom11 sites

  • Department of Gastroenterology

    Bristol, BS2 8HW

  • Addenbrookes Hospital

    Cambridge, CB2 2QQ

  • Department of Medicine

    Cardiff, CF 14 4XW

  • Department of Gastroenterology

    Dartford, Kent, DA2 8DA

  • Department of Gastroenterology

    London, NW3 2QG

  • Department of Gastroenterology

    London, W12 0HS

  • Department of Gastroenterology

    London, W1N 8AA

  • Department of Gastroenterology

    Manchester, M13 9WL

  • St. Mark's Hospital

    Middlesex, HA 1 3UI

  • Department of Gastroentroerology

    Newcastle, NE1 4LP

  • Study site

    Nottingham

Other trials in United Kingdom

United States5 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Springfield Clinic

    Springfield, Illinois, 62794-9248

  • Advanced Clinical Therapeutics

    Tucson, Arizona, 85712

  • Washington Hospital Center Physicians Office Building

    Washington D.C., District of Columbia, 20010

Other trials in United States

Israel3 sites

  • Rambam Hospital

    Haifa

  • Department of Medicine A, Liver & Gastroenterology Units

    Jerusalem, 91120

  • Department of Gastroenterology and Hepatology

    Tel HaShomer, 52621

Other trials in Israel

France1 site

  • Hopital Saint Louis

    Paris, 75010

Other trials in France

About this study

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

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
Being tested
CC-5013
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-5013Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2007 (estimated)
  2. Study startMar 2002
  3. Study completionDec 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00446433
Sponsor's protocol ID
CC-5013-CD-001
Status last verified
Nov 2016
First submitted
7 Mar 2007
Last updated
1 Dec 2016
Results posted
No

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. doi: 10.1111/j.1365-2036.2007.03385.x.

    PubMed 17635377

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-5013 in people with Crohn's Disease, run by Celgene Corporation at 20 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United Kingdom, United States, Israel, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00446433, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.

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