Trial Contacts
I3 - Research Coordinator: 215-360-0904
I3Study@uphs.upenn.edu
www.i3study.org
PIANO - Research Coordinator:
215-662-8919
Target-IBD
Primary Investigator: Faten Aberra, MD, MSCE
Research Coordinator: Alice Alderson
alice.alderson@pennmedicine.upenn.edu
215-360-0905
Studies
Target-IBD
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease (Target-IBD)
The goals of this study are to collect information on patients with IBD to determine the natural course of the disease and to determine how procedures or treatments that may be recommended by your doctors may affect IBD and general health. This research study is intended to observe any treatment for IBD in a large number of people in a "real life" setting. Researchers are interested in observing how these treatments, lifestyle changes, and counseling work in patients who are treated by their doctors in routine practice. Information about which treatments are being used and responses to these treatments will be collected to help researchers better understand how IBD is managed.
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) 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.
3) Must be seen within the Penn Health System.
Exclusion Criteria:
1) Inability to provide written 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.
PIANO
Inflammatory Bowel Disease and Neonatal Outcomes
I3: IBD Immunology Initiative
A translational clinical and tissue database study.
Actively enrolling all Crohn's disease and Ulcerative Colitis patients seen within the University of Pennsylvania Health System. The aim is to understand abnormalities in the immune system and other factors that impact IBD.
Ulcerative Colitis
Title: Moderate to Severe Ulcerative Colitis: A Single Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668
Sponsor: Abbvie
Primary Investigator: Faten Aberra, MD
CONTACT: Julie Starr (julie.starr@pennmedicine.upenn.edu or 215-349-8527)
Eligibility Criteria:
- Adult male or female, at least 18 years old at time of the Baseline visit.
- Diagnosis of UC for at least 90 days prior to Baseline.
- Subject meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review)
- Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or biologics or targeted immunomodulators.
Title: A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults with Mild to Moderate Ulcerative Colitis
Sponsor: Ferring Pharmaceutical
Primary Investigator: Neilanjan Nandi, MD
CONTACT: Christine Gepty (christine.gepty@pennmedicine.upenn.edu or 215-349-8556)
Inclusion Criteria:
- Subject aged ≥18 at screening.
- Established diagnosis of ulcerative colitis (UC) by standard clinical, endoscopic and histological criteria, for more than 3 months at screening.
- Active mild to moderate UC as defined by a modified Mayo score ≥4 and ≤7, including an endoscopic subscore ≥2 and a rectal bleeding subscore ≥1 at randomization.
- Currently not treated, or on stable (i.e., no change in therapy and/or dose) treatment with 5-aminoasylic acid (5-ASA), immunomodulators (e.g., azathioprine (AZA), 6- mercaptopurine (6-MP), methotrexate, and cyclosporine), and/or corticosteroids to manage active UC
Exclusion Criteria:
- Active disease or history of Crohn’s disease
- Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC
- Active gastrointestinal infection
- Previous failure, or loss of response, to 3 or more biologics and/or small molecules for treatment of UC
- Use of >25 mg of prednisolone or equivalent corticosteroid dose per day
Crohn’s Disease
Title: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD)
Sponsor: Janssen
Primary Investigator: Faten Aberra, MD
CONTACT: Christine Gepty (christine.gepty@pennmedicine.upenn.edu or 215-349-8556)
Inclusion Criteria:
- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
- If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion Criteria:
- Complications of CD that may be anticipated to require surgery
- Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
- Has a draining (example, functioning) stoma or ostomy
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer