Edward V. Loftus, Jr., M.D.

The purpose of this study is to demonstrate the effectiveness of GS-5290, compared to placebo control, in achieving Clinical Response at Week 12.

The purpose of this study is to evaluate the effectiveness of MK-7240 compared to Placebo as assessed by the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12 and at Week 52 for Moderate to Severe Ulcerative Colitis. 
 

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

To evaluate safety and efficacy of two dosing regimens in achieving clinical remission at Week 8 in subjects with moderately to severely active Ulcerative Colitis.

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 Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).

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 Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).

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.

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

The purpose of this study is to assess how safe and effective lutikizumab is in adult subjects with UC and how lutikizumab compares to adalimumab in the treatment of UC. 

The purpose of this study is to assess how safe and effective lutikizumab is in adult subjects with UC and how lutikizumab compares to adalimumab in the treatment of UC. 

This study will evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.

The study consists of 3 sub-studies, as follows: 

Sub-study 1 (Randomized, double-blind, placebo controlled study)

• The purpose is to evaluate the effectiveness and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately-to-severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991.

Sub-study 2 (Randomized, exploratory maintenance study)

• The purpose is to evaluate the effectiveness and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active CD who responded to induction treatment in Study M16-006 or Study M15-991.

Sub-study 3 (Open-label, long-term extension study)

• The purpose is to evaluate the long-term safety of risankizumab in subjects who completed Sub-study 1, Sub-study 2, or the Phase 2, open-label extension study, Study M15-989. Additional objectives are to further investigate long-term effectiveness and tolerability of risankizumab.

The study consists of 3 sub-studies, as follows: 

Sub-study 1 (Randomized, double-blind, placebo controlled study)

• The purpose is to evaluate the effectiveness and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately-to-severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991.

Sub-study 2 (Randomized, exploratory maintenance study)

• The purpose is to evaluate the effectiveness and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active CD who responded to induction treatment in Study M16-006 or Study M15-991.

Sub-study 3 (Open-label, long-term extension study)

• The purpose is to evaluate the long-term safety of risankizumab in subjects who completed Sub-study 1, Sub-study 2, or the Phase 2, open-label extension study, Study M15-989. Additional objectives are to further investigate long-term effectiveness and tolerability of risankizumab.

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active Crohn's disease (CD).

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.

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.

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

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.

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 Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

This study comprises three sub-studies. The objective of sub-study 1 was to characterize the dose-response, efficacy, and safety of  upadacitinib compared to placebo in inducing clinical remission per Adapted Mayo score (using the Mayo Scoring System for Assessment of Ulcerative Colitis Activity, excluding Physician's Global Assessment [PGA]) in subjects with moderately-to-severely active UC in order to identify the induction dose of upadacitinib for further evaluation in Phase 3 studies including Substudy 2.

The primary objective of Substudy 2 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg QD compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately-to-severely active UC who are bio-IR or non-bio-IR.

The primary objective of Substudy 3 (Phase 3 maintenance) is to evaluate the efficacy and safety of upadacitinib 30 mg QD and 15 mg QD compared to placebo in achieving clinical remission (per Adapted Mayo score) in subjects with moderately to severely active UC who achieved clinical response (per Adapted Mayo score) following induction therapy from Study M14-234 Substudy 1, Substudy 2, or Study M14-675. Study M14-675 is an induction study in patients with moderately-to-severely active UC.

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

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.

The purpose of this study is to assess the effectiveness and safety of BMS-986165 in ulcerative colitis.

The purpose of this study is to evaluate the safety and efficacy of GS-5745 in adults with active Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by an Open Label Extension. Participants who complete the Blinded Treatment Period will be eligible to enroll in the optional Open Label Extension for an additional 44 weeks.

The purpose of this study is to determine the effectiveness of RPC1063 in the initial treatment of moderate to severely active Crohn's disease.

The purpose of this study is to evaluate the accuracy of the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC).

The purpose of this study is to evaluate the effectiveness and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

This study is designed to evaluate the long-term safety and efficacy of ABT-494 in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study M14-234.

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active Crohn's disease (CD) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

The purpose of this study is to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active Crohn's Disease.

The purpose of this study is to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients diagnosed with moderate to severe ulcerative colitis.

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

The purpose of this study is to evaluate how well risankizumab works compared to ustekinumab to treat Crohn's disease.

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. 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. 

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The purpose of this study is to evaluate the effectiveness and safety of continuing ustekinumab as a subcutaneous (injection) maintenance therapy in patients with moderately to severely active ulcerative colitis (UC) who have demonstrated a clinical response to an induction treatment with IV ustekinumab.

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

The purpose of this study is to assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active Crohn's Disease (CD) in adult participants.

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study.

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. All patients who complete the study will have the option to enter a long term active treatment study.

The purpose of this study is to obtain long term safety and tolerability data of vedolizumab subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's disease (CD).

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of giving repeat doses of ABT-494 to treat patients who have Crohn's disease.

The purpose of this study is to evaluate the effectiveness and safety of MEDI2070 in subjects with moderate to severe crohn's disease who have failed or are intolerant to anti-tumor necrosis-factor-alpha therapy.

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease of 70 points in Crohn's Disease Activity Index (CDAI) from baseline (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease of 70 points in Crohn's Disease Activity Index (CDAI) from baseline (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.

The cause of UC is not well understood. It is believed to be caused from an abnormal immune response to the normal bacteria that live in the gut (intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel by a person's own immune cells which leads to disease.

It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple sclerosis are more common in industrialized, well-developed countries with better sanitation and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs and parasites naturally found in the environment. This reduced exposure may trigger responses in the body that make people more prone to diseases such as UC. People in non-industrialized countries and the tropics, where parasites are common, rarely develop these diseases. This observation has led researchers to want to better understand the relationship between the lack of natural bacteria in the gut and the onset of autoimmune diseases like as UC.

The purpose of this study is to evaluate perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).

This is a randomized, double blind, placebo controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (total Mayo Score < 2 points with no individual subscore > 1 point) at week 8. After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 50% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, subjects will enter an open label period during which all subjects will receive open label AMG 181 at a single dose level according to protocol. Subjects who failed to achieve a response at week 8 and also have an inadequate response at week 12 or after are eligible to enter the open label period of the study early. Subjects who achieved response and/or remission at week 8 and subsequently experience disease worsening are eligible to enter the open label period early ONLY if a confirmatory rectosigmoidoscopy confirms disease severity as defined by protocol. Subjects that complete the open label period or early terminate from the study will enter the 2 year safety follow up period.

The purpose of this study is to evaluate the effectiveness and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment for patients who have ulcerative colitis.

This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (CDAI score < 150) at week 8 (primary endpoint). After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 80% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, subjects will enter an open-label period during which all subjects will receive open-label AMG 181 at a single dose level according to protocol. Subjects who fail to achieve minimal improvement, or experience disease worsening after initial response are eligible to enter the open-label period early beginning at week 12 or after. Subjects that complete the open-label period or early terminate from the study will enter the 2 year safety follow up period.

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 7 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

The purpose of this extension study is to monitor the safety and effectiveness of etrolizumab treatment in patients with moderate to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899).

The purpose of this study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Crohn's disease (CD).

The primary aim of this study is to compare the degree and characteristics of disease-related knowledge of patients with IBD between Korea (3 tertiary referral hospitals) and USA (Mayo clinic, Rochester, Minnesota) via the use of a questionnaire and medical record review.

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis or Crohn's Disease.

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis or Crohn's Disease.

This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in participants with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of TNF inhibitors.

This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in participants with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of TNF inhibitors.

This Phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are naïve to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

The purpose of this study is to evaluate the effects of Remicade (infliximab) for the treatment of active Crohn's disease and  may be useful in preventing a relapse of Crohn's disease after surgical resection.

The purpose of this study is to investigate the safety and effectiveness of methotrexate for the initial treatment and the maintenance of a steroid free remission, for patients who have active ulcerative colitis.

The purpose of this study is to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

Primary Aim

            We aim to evaluate: 1) the correlation between patient-reported rectal bleeding and stool frequency and health-related quality of life focused on fatigue, depression and anxiety, and work productivity; and 2) the correlation between the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.

Secondary Aims

We also aim to evaluate the correlation between the combination of clinical/PRO and the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.