Inflammatory Bowel Disease clinical trials at University of California Health
57 in progress, 20 open to eligible people
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
open to eligible people ages 2-19
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.
at UCSF
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
open to eligible people ages 18-75
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
at UC Davis UCSD UCSF
A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
open to eligible people ages 18-80
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.
at UCSD
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
open to eligible people ages 18 years and up
CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.
at UC Irvine UCLA
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
open to eligible people ages 2-17
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
at UCSF
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
open to eligible people ages 2-17
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
at UCSF
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
open to eligible people ages 12-17
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.
at UCSF
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
open to eligible people ages 18-75
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
at UC Davis UCSD UCSF
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
open to eligible people ages 18-80
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.
at UC Irvine UCSD
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
open to eligible people ages 2-17
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met. The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.
at UCSF
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
open to eligible people ages 18-75
This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.
at UC Davis UCSD UCSF
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
open to eligible people ages 18-80
Approximately 20-40% of patients with ulcerative colitis (UC) are obese. The investigators have demonstrated that obesity adversely impacts disease course in patients with UC, leading to higher risk of persistently active disease, surgery, hospitalization, and treatment failure, particularly in biologic-treated patients. Intentional weight loss is effective in improving disease outcomes in patients with inflammatory arthritis, but there is limited data on its impact in UC. While dietary interventions for weight loss have limited efficacy and endoscopic bariatric interventions may be too invasive in patients with UC with active gastrointestinal symptoms, pharmacological weight loss with a highly effective oral agent may be a novel strategy to induce weight loss and augment the efficacy of biologic therapy in UC. Hence, the investigators are conducting a pilot, phase 2A, 22-week, randomized, placebo-controlled clinical trial of phentermine-topiramate in obese patients with active UC starting on a new biologic agent (infliximab, adalimumab, golimumab, vedolizumab). The overall objective is to (1) evaluate the efficacy, safety and tolerability of phentermine-topiramate, and (2) to assess the impact of pharmacological weight loss on clinical outcomes, inflammatory burden and biologic trough concentration in patients with UC. The central hypothesis is that phentermine-topiramate will be safe, effective, and well tolerated in patients with UC, and weight loss would achieve higher rates of clinical and biochemical remission, and higher biologic trough concentration.
at UCSD
Study of Dietary Composition in Crohn's Disease
open to eligible people ages 18-75
Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and altered composition and function of the gut microbiome. We anticipate the anti-inflammatory diet, when compared with the usual diet, to produce favorable changes in these multi-omics profiles. These findings will provide insight into the interactions between diet and host biology, while providing clues on the mechanisms of diet therapy's effect and CD pathogenesis.
at UCLA
Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
open to eligible people ages 18-80
The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis [UC]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.
at UCSD
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
open to eligible females ages 18-45
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 18 years from birth.
at UCSF
An Observational Study: 5-year Long-Term Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
“Researchers are collecting information on patients with inflammatory bowel disease (IBD). Help us learn how to better treat and manage it!”
open to eligible people ages 2 years and up
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.
at UC Davis
OTIS Autoimmune Diseases in Pregnancy Project
open to eligible females
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
at UCSD
Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI Biomarker Panel and Algorithm to Detect Mucosal Healing in Moderate to Severe Ulcerative Colitis Patients.
open to eligible people ages 18-65
The purpose of this research study is to determine the efficacy and outcome of the UCRI (an in-vitro diagnostics device in the form of a blood test and an algorithm) as a tool to detect mucosal healing (level of inflammation in the colon) in people with moderate-to-severe ulcerative colitis treated with anti-TNFα. Another reason is to explore additional biomarkers in blood, stool or voice to detect disease activity and/or mucosal healing. A tool to detect the level of inflammation in the colon based on blood, stool or voice biomarkers may reduce the need or the number of invasive endoscopic procedures. This is an observational study and no treatment decision nor clinical intervention will be done based on results during this study and all collected data will be used only for the goal of the study and for obtaining FDA IDE for a follow-up study.
at UC Davis UC Irvine
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
open to eligible females
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
at UCSD
Treatment of Perianal Disease Using Adipose-derived Stem Cells
open to eligible people ages 18 years and up
This study will compare healing and surgical outcomes in patients with chronic perianal disease treated with Adipose-derived Stem Cells (ASCs) to outcomes in patients treated in traditional surgical techniques without ASCs. The study will perform retrospective medical record analysis to clinically characterize patients that have undergone these surgical procedures and compare follow-up data and disease status to determine efficacy of treatment with ASCs compared to similar treatments without the use of ASCs. This will help determine overall efficacy of the treatment as well as determine patient characteristics that may predict treatment success. The study will also prospectively recruit patients with perianal disease that are planning to receive treatment with ASCs, and analyze their outcomes in the same way. Medical record review of outcomes in patients with perianal disease that received treatment with ASCs compared to those that did not will determine efficacy of this procedure.
at UCSD
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Sorry, not currently recruiting here
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
at UCSF
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433
Sorry, in progress, not accepting new patients
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
at UCSD UCSF
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
at UCSF
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Sorry, in progress, not accepting new patients
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
at UCSD UCSF
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
at UCSD UCSF
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
Sorry, not currently recruiting here
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
at UC Irvine UCLA UCSD UCSF
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Sorry, not currently recruiting here
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
at UCSD UCSF
A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Sorry, not currently recruiting here
The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.
at UCSF
A Study of Guselkumab in Moderately to Severely Active Crohn's Disease
“Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
at UC Davis UCSD
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Sorry, not currently recruiting here
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
at UCSD
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
at UCLA
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Sorry, in progress, not accepting new patients
This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab. The study will last about 52 weeks and may include up to 18 visits.
at UCSF
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Sorry, in progress, not accepting new patients
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
at UC Irvine
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Sorry, in progress, not accepting new patients
The study consists of 4 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; - Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. - OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
at UCSD UCSF
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.
at UCSF
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions.
at UCSD UCSF
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
Sorry, not currently recruiting here
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
at UC Davis UCSF
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
Sorry, in progress, not accepting new patients
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
at UCSD UCSF
A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)
Sorry, in progress, not accepting new patients
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.
at UCSD
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Sorry, not currently recruiting here
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
at UC Irvine UCSD
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Sorry, not currently recruiting here
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
at UCSD UCSF
Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Sorry, accepting new patients by invitation only
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).
at UCSD
Join a study of an investigational treatment for Crohn's Disease!
“Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”
Sorry, in progress, not accepting new patients
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
at UC Davis UCSF
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Sorry, in progress, not accepting new patients
The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.
at UCSF
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Sorry, in progress, not accepting new patients
The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
at UCSF
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
Sorry, not currently recruiting here
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
at UC Davis
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Sorry, in progress, not accepting new patients
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
at UCSD UCSF
Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
Sorry, not currently recruiting here
This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to moderate Crohn's disease (CD) who have a microbiome profile associated with increased risk of early relapse. This an add-on design trial for subjects already receiving standard of care therapy to induce remission; there will be no placebos.
at UCSF
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
Sorry, in progress, not accepting new patients
This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
at UC Irvine UCSD UCSF
Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.
at UC Irvine UCSD UCSF
Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
Sorry, not currently recruiting here
Delivery of healthcare has been traditionally limited to in-person visits or hospitalizations, while patients spend the majority of their time at home or work. Digital Medicine (e.g. apps, remote monitoring, telemedicine, patient reported outcomes) has the potential to bridge this gap, but the question remains as to how to translate it to mainstream practice while providing individualized recommendations to improve population health across organizations. Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), the study team plans to reduce digital disparities and scientifically test the impact of these technologies in a clinical trial in three CTSA sites catering to diverse populations and communities.
at UC Davis
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
Sorry, in progress, not accepting new patients
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
at UCSD
A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
Sorry, in progress, not accepting new patients
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
at UCSF
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
Sorry, not yet accepting patients
Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children. While the exact cause of CD is not certain it is thought that the immune system located in the intestine reacts abnormally to the large number of bacteria contained there. The investigators think that diet, exposure to antibiotics early in life, and having a family history of CD puts people at increased risk for developing CD. In order to decrease the inflammation doctors use what is called biologic therapy with anti-TNF molecules that can be given through an intravenous or shots. TNF is a chemical made by white blood cells that is involved in inflammation. When this type of treatment is given early after diagnosis it is more effective than when it is given later. The investigators have learned that it is important to give the optimum (ideal) amount of this medicine guided by certain blood tests. The investigators also know that not everyone responds to this therapy but do not understand the reasons for this variability between people. The CAMEO study has been started to help understand what factors are important in determining whether a child with CD completely heals the inflammation after anti-TNF therapy. The investigators will do that by measuring certain markers of inflammation in the blood and stool and by looking at a person's genes (DNA) and how inflammation is controlled in the intestine. These inflammation tests will be done before, during, and after one year of anti-TNF therapy. The investigators will determine how much healing has taken place by comparing the results of the colonoscopy and a special type of MRI that are both done before anti-TNF and then again one year later. The goal in treating CD is to heal both the lining and the wall of the intestine. Children ages 6-17 years who are thought to have CD and are about to undergo their diagnostic colonoscopy are eligible to be enrolled. If they are found to indeed have CD and start an anti-TNF medicine within 6 months they can continue in the study. There are no increased risks of participating in this study beyond those normally associated with having CD and its treatment. By better understanding why the bowel does or does not heal, doctors will be better able to provide personalized care.
at UCSD UCSF
Improving the Quality of Care for Adults With Inflammatory Bowel Disease
Sorry, accepting new patients by invitation only
Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared information environment, that highlights collaboration among patients, clinicians and care team members, and researchers; for effective use of data for guiding care, value, improvement, and research.
at UCSD
Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
Sorry, in progress, not accepting new patients
This is an open-label, prospective, observational study with the primary objective to characterize the pharmacokinetics of infliximab in patients with Acute Severe Ulcerative Colitis.
at UCSD
Phenotyping IBS: Perceptions and Modulations of Visceral Sensations
Sorry, in progress, not accepting new patients
The purpose of this research study is to improve the understanding of irritable bowel syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared to healthy controls and people with ulcerative colitis, a disease group that has already been characterized. By doing this correlative and comparative study, the investigators hope to gain knowledge on IBS in order to keep the field moving in the right direction and becoming one step closer to discovering effective treatments.
at UCLA
Our lead scientists for Inflammatory Bowel Disease research studies include Zhaoping Li, MD, PhD Christina Chambers, PhD Eric J Mao, MD Samuel Eisenstein, MD Nimisha Parekh Sofia G Verstraete Uma Mahadevan, MD Siddharth Singh, MD.
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