A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

Study Purpose

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Observational [Patient Registry]
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) being prescribed any IBD treatment (initial or subsequent) outside of a clinical trial. 2. Have plans for future visits at the site for continued management of IBD.

Exclusion Criteria:

1. Inability to provide written informed consent/assent. 2. Being enrolled in any interventional study or trial for IBD treatment. Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries). 3. Prior total abdominal colectomy for UC or IBDU.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03251118

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Target PharmaSolutions, Inc.

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33762

Site Contact

Shannon Brewington

sbrewington@gastrofl.com

984-234-0268

Palm Harbor, Florida

Status

Recruiting

Address

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684

Site Contact

Joanne Root

research@advancedgastro.com

984-234-0268

Indianapolis, Indiana

Status

Recruiting

Address

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, 46237

Site Contact

Wendy Weigel-Timpany

wweigel-timpany@indygastro.com

984-234-0268

Louisiana Research Center, LLC, Shreveport, Louisiana

Status

Recruiting

Address

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105

Site Contact

Beverly Carroll

bcarroll@gis.md

984-234-0268

New Brunswick, New Jersey

Status

Not yet recruiting

Address

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901

Site Contact

Tina John

tj190@sph.rutgers.edu

984-234-0268

University of North Carolina, Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27599

Site Contact

Susan Jackson

susan_jackson@med.unc.edu

984-234-0268

Digestive Health Specialists, PA, Winston-Salem, North Carolina

Status

Recruiting

Address

Digestive Health Specialists, PA

Winston-Salem, North Carolina, 27103

Site Contact

Stephanie Riggs

stephanier@digestivehealth.ws

984-234-0268

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Julie Starr

jstarr@mail.med.upenn.edu

984-234-0268

University of Washington, Seattle, Washington

Status

Not yet recruiting

Address

University of Washington

Seattle, Washington, 98195

Site Contact

Elisa Beebe

ebeebe@medicine.washington.edu

984-234-0268

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