Department of Defense Peer Reviewed Medical Research Program
Funding Opportunities for Fiscal Year 2010

The Fiscal Year 2010 (FY10) Defense Appropriations Act provides $50 million to the Department of Defense Peer Reviewed Medical Research Program (PRMRP).

   The vision of the PRMRP is to identify and fund the best medical research to protect and support warfighters, veterans, and all beneficiaries and to eradicate diseases that impact these populations. The PRMRP challenges the scientific and clinical communities to address one of the FY10 congressionally directed topic areas with original ideas that foster new directions in basic science and translational research; novel product development leading to improved therapeutic or diagnostic tools, or improvements in clinical policies/guidelines; or clinical trials that address an immediate clinical need. This program is administered by the U.S. Army Medical Research and Materiel Command through the Office of the Congressionally Directed Medical Research Programs (CDMRP).  Further information available here.

Shop and Give

Food Lion Shop & Share Program

        CCFA has registered select east coast chapters to the Food Lion Shop & Share Program. Every time you make a purchase by using your MVP card, Food Lion will make a donation to the local CCFA chapter. To register for a MVP card with the Food Lion Shop & Share Program, or call 1-800-210-9569. Be sure to choose the Crohn's & Colitis Foundation of America for your local chapter. Chapters registered in the Food Lion Shop & Share Program are Greater Washington DC/Virginia, Philadelphia/Delaware, Carolinas, Georgia/ Tennessee, Western Pennsylvania/West Virginia, Maryland/South Delaware, Florida, and Kentucky

Your Dollars At Work

SAVE THE DATE!

A co-ed residential camp for kids with Crohn's disease and Ulcerative Colitis

Our 2010 session will be held at Camp Nock-A-Mixon
located in Kintnersville, Bucks County, PA

Applications are available for campers (rising 4th-11th), Leaders in Training (rising 12th), ) and volunteers (19+)  (Space is Limited and registration closes June 1, 2010)

Click here to learn more about this exciting program, or contact Janet Domolky, Camp Contact at
1-877-807-5271

The chapter would like to offer it's heartfelt thanks and appreciation to the following pharmaceutical companies, who have graciously contributed to making our education programs possible.

CCFA Community • Giving You the Tools to Cope

Whether you're a newly diagnosed Crohn's or ulcerative colitis patient, or a friend or family member of someone with one of these diseases, join the thousands of others online at our online community and get the support you need. 

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Patient Support Program

Power of Two

The Power of Two program provides one-to-one support and compassion to patients and their families suffering from Crohn's disease and ulcerative colitis.  Individuals participating in the program are matched to volunteers who have had similar challenges and experiences for phone or email conversations.

This program is open to adults with IBD as well as parents of children with IBD.  We are working to expand this program to serve spouses of people with IBD and teens.

Clinical Trials

Protocol Number: 09-I-0175
 
Active Accrual, Protocols Recruiting New Patients

Title:  NIH Substudy for a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of Two Single IV Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients with Moderate to Severe Active Crohn's Disease

Purpose:  Crohn's disease is an inflammatory bowel disease with major symptoms such as diarrhea and abdominal pain when the disease is in an active stage. AIN457 is a drug developed by NOVARTIS that is used to stop the action of Interleukin-17 (IL-17), a protein made by the body that contributes to many different kinds of inflammatory diseases, including Crohn's disease. AIN457 has not yet been approved by the Food and Drug Administration and is being developed for the potential treatment of various inflammatory diseases like rheumatoid arthritis and psoriasis, as well as Crohn's disease.

Objectives:  The main objective of the multicenter study (sponsored by NOVARTIS) is to determine whether AIN457 is safe and effective in the treatment of Crohn's disease, and if effective, how long the effect will remain.  The main objective of the NIH sub-study is to obtain additional blood and gut biopsy tissue for monitoring biochemical changes in immune variables in response to study drug or placebo.

Eligibility:  Important eligibility criteria to consider for patients to be enrolled in the AIN457 trial include:

Inclusion criteria:

• Male or female; 18-75 years old
• Diagnosis of Crohn's disease for at least 3 months prior to screening
• Moderate to severe active Crohn's disease at baseline, defined as:  CDAI ≥220 and ≤450
• Active disease despite prior treatment with stable dose of corticosteroids for 2 weeks, or immunosuppressant for at least 3 months (e.g. methotrexate, azathioprine).

Exclusion criteria:

• Subjects with symptoms associated with active bowel stricturing disease and pre-stenotic dilation on radiography. 
• Fistulizing disease if complicated by sepsis and/or untreated abscess.
• Subjects with multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake. 
• Prior therapy with rituximab. 
• Receiving corticosteroids dose equivalent to a >40mg dose of prednisone per day.
• Subjects demonstrating clinical improvement due to other Crohn's therapy.
• Subjects with active or history of clinically significant cardiac abnormalities.

Design:  The multicenter study plans to enroll seventy-two (72) subjects with moderate to severe active Crohn's disease that is not controlled by corticosteroids, immunosuppressant (e.g. methotrexate or purine metabolites) or anti-inflammatory treatment (e.g. 5-ASA). At baseline visit, if the eligibility of the subject is confirmed, the subject will be randomized (2:1 ratio) to receive either AIN457 or placebo administered as a 2 hours intravenous infusion. A total of 2 infusions will be given on day 1 and day 22 respectively. After infusions there will be a follow-up period of up to 18 weeks.
For the NIH sub-study, additional blood will be drawn and a colonoscopy will be performed before the first infusion and after the second infusion.

Once this study is completed, an extension study will be conducted that will offer access to AIN457. Patients who complete the current study may be eligible to enter the extension study and receive therapy with AIN457.

Participating Site Contact Information:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Michael Yao, MD, NIH Principal Investigator • Tyra Estwick, RN, BSN, NIH Research Nurse

Building: 10 CRC, Room 6-3742                 Building 10 CRC, Room 5-3750
  Telephone:  301-594-0593  301-594-0593                              Telephone:  301-496-3429  301-496-3429

The Home Telemanagement Trial (UC HAT)
for Patients with Ulcerative Colitis

The purpose of the study is to determine if a home telemanagement system for patients with ulcerative colitis (UC HAT) improves clinical outcomes compared to routine care.  A computer program will assign interested patients by chance to either the UC HAT or the routine care group.

Patients in the UC HAT group will be asked to complete self-testing each week at home using the system.

All patients will undergo research visits every 4 months for one year. Patients will complete a series of questionnaires at each visit that measure the patients disease activity, quality of life, IBD knowledge, medical compliance, and other parameters.  Emergency room visits and hospitalizations will also be measured.  A blood draw is required at each study visit.

If UC HAT is effective, the system could be used in the IBD community to improve clinical care or be used in patients with limited access to health care.

Get More Information - or call Nadia Cheevers at  410-706-3398  410-706-3398

Test - Treat Strategy to Prevent Ulcerative Colitis
Relapse Dose Escalation and Remission (DEAR) Study

The proposed study will test whether incresing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients wiht inactive ulcerative colitis.  Sixty patients with FCP levels <50mcg/gm stool will be observed for 48 weeks.  All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks.  All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda.  Reduction in FCP levels below 50mcg/gm stool 6 weeks after randomization will be the primary outcome.  The percentage of patients achieving this outcome will then be compared between groups.  All randomized patients (as well as those who were excluded from the trial because of a low FCP concentration at baseline) will be followed to week 48 to determine the rate of clinical relapse.

Get Further Information or call Lee Ann Pazulski at  410-706-4310  410-706-4310

A 5-Year, Registry Study of Humira (Adalimumab)
in Patients with Moderately to Severely Active
Crohn's Disease (CD)

The proposed study will evaluate the safety of Humira (Adalimumab)
in patients with moderately to severely active CD already receiving
Humira as part of their medical treatment.  Investigators will collect
safety data over time in patients treated with Humira. 
This will assist in the clarification of the
short and long-term safety profile of the medication.
For more information, contact Lee Ann Pazulski at  410-706-4310  410-706-4310

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Oral and Rectal Budesonide for the Treatment of Extensive Ulcerative Colitis:  A Pilot Study

The purpose of this study is to evaluate whether the combination of oral and rectal budesonide is effective in the treatment of patients with moderately active ulcerative colitis (UC).  In addition, the study will evaluate whether the combination of oral and rectal budesonide is better tolerated than conventional steroids.  Tweny patients will be recruited in this open study.  All eligible patients will receive a combination of oral budesonide and rectal budesonide for eight weeks.  Both forms of budesonide will be tapered according to the investigators preference after week 8. Clinical visits will take place at bseline and 8 weeks.  In addition, telephone follow up will take place at weeks 2, 4, 6, 10, 12, 26, and 52.  Assessment of efficacy and safety will take place at the follow up clinic visit and at each telephone follow up.

For more information, see trials.gov or call Nadia Cheevers at  410-706-3398  410-706-3398

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For a list of doctors who have supported this chapter
please see More Information below