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

N/AActive Not RecruitingNCT03251118

Target PharmaSolutions, Inc.15,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

15,000

Conditions

Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis Indeterminate Colitis

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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) having been 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. Note: 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.

Locations (37)

Om Research

Lancaster, California, United States

FACEY Medical Foundation

Mission Hills, California, United States

University of California - Davis

Sacramento, California, United States

Stanford University

Stanford, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Natural history of Inflammatory Bowel Disease: Characteristics of IBD

Time frame: Up to 5 years

Natural history of Inflammatory Bowel Disease: Participant demographics

Time frame: Up to 5 years

Natural history of Inflammatory Bowel Disease: Treatment use

Time frame: Up to 5 years

Natural history of Inflammatory Bowel Disease: Treatment response

Time frame: Up to 5 years

Natural history of Inflammatory Bowel Disease: Disease progression

Time frame: Up to 5 years