Crohn's Disease Research | Ulcerative Colitis Research | Healthy Volunteers Accepted
GEM Project: A Multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel Disease
The GEM Project is a research study attempting to determine possible causes for Crohn’s Disease by following healthy individuals who are at a higher risk for developing the disease over time. This study is for healthy individuals who have a sibling and/or parent with Crohn’s Disease. To find out more information, click here: http://www.gemproject.ca.
Healthy patients must be between ages 6 and 35, and have either a sibling or parent with Crohn's Disease.
SHARE: Translational Studies in Inflammatory Bowel Disease
SHARE is an observational research study that will build a registry of patients recently diagnosed with IBD. Patients will be recruited and asked to provide clinical information and donate blood samples. Approximately 10,500 patients will be enrolled over a 5-year period at 7 investigational sites. Follow-up will occur every 6 months until the study ends. The goal of the study is to create a database of clinical information and a repository of biological specimens for genetic, molecular and microbiological research to better understand IBD and help develop new therapies.
We are not currently enrolling new patients, but this study is ongoing.
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease (PIANO)
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to one year from birth. We are looking for 660 pregnant women to enroll in the duration of 3 years.
Patients ages 18 to 45 may enroll. This study is for all pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants.
SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and it's objective is to monitor patients for approximately 10 years.
Patients must be at least 18 years of age to enroll. The study accepts patients about to receive treatment with Cimzia® as part of pre-existing management plan for Crohn's Disease or has already been receiving treatment with Cimzia® for < 6 months, or control patients about to receive treatment with any other medication as part of a pre-existing management plan for Crohn's Disease or has already been receiving treatment (previous Cimzia® treatment is prohibited).
PUCCINI: Prospective Cohort of Ulcerative Colitis and Crohn’s Disease Patients Undergoing Surgerty to Identify Risk Factors for Post-Operative Infection
The purpose of this research study is to determine whether exposure to anti-TNF antibodies is an independent risk factor for post-operative infection in CD and UC. Also, to explore other possible risk factors for post-operative infection.
Once a potential subject is identified, s/he will be approached by the study coordinator or investigator, and asked to participate. Eligible participants will then undergo a baseline interview (during hospitalization prior to surgery and up to 4 days post-surgery) and a follow-up telephone interview (30 days after surgery +/- 7 days).
Patients must be at least 18 years of age, have an IBD diagnosis, and plan to have abdominal surgery.
Crib: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol).
This research study is being conducted to evaluate the placental transfer of Cimzia® in pregnant women receiving treatment with Cimzia®, to determine if Cimzia® crosses from the mother through the placenta to the infant. There is little data on the effects of Cimzia® in pregnant women or the effects on the fetus and infant. This study will examine your infant’s blood to determine if any Cimzia® is in their blood and if so, how much. The information collected will be made available to the general public as well as treating physicians and may help improve treatment decisions for pregnant women who are being treated with Cimzia® in the future
Patients must be 18 years of age or older, at least 30 weeks pregnant, taking Cimzia for an approved indication, and are likely to receive Cimzia within 35 days prior to expected delivery. Patients may pre-register their interest at any time.
Trial of High-Dose Vitamin D in Patients with Crohn's Disease: RODIN-CD
Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study the effects of high dose vitamin D supplementation in patients with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.
Criteria: Diagnosis of CD; 18 years to 75 years; Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D < 30ng/ml).
MAAIS: Mid-Atlantic African American IBD Study
MAAIS is a research study attempting to determine possible causes for Crohn’s Disease in blacks / African Americans. A gene (NOD2) has been found to be important in the development of disease in 25% of whites, but it does not seem to play a role in African Americans. This study is looking for genes that cause IBD specifically in the African American population.
African American IBD patients older than 18 can participate. We are also looking for healthy controls that are also African American and within 10 years of the patient’s age.
HICKORY: A Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis Who Are Refractory to or Intolerant of TNF Inhibitors
Purpose: This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of tumor necrosis factor (TNF) inhibitors.
- 18-80 years of age, inclusive
- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
- Intolerance, loss response or failure to respond to treatment with at least one TNF-inhibitor within the previous 5 years
- Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period
- Use of highly effective contraception as defined by the protocol
- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
- Prior or planned surgery for UC
- Past or present ileostomy or colostomy
- Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol
- Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent).
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohns Disease Who Have Inadequately Responded to or Are Intolerant to Anti-TNF Therapy
Purpose: To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to anti-Tumor Necrosis Factor (TNF) therapy.
Ages: 18 Years to 75 Years
Criteria: Diagnosis of Crohn's disease (CD) for at least 90 days with inadequate response or intolerance to previous treatment with anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).