Funding
Current Funding:
R01 GM097117 (Higgins) 8/1/12-4/30/17 4.8 cal mo
NIH $244,582
Application of Machine Learning Algorithms to Thiopurine Monitoring in IBD
The specific aims of this proposal are to: (1) use longitudinal clinical data and novel mathematical methods to improve the existing algorithm for clinical response to thiopurine therapy, using active bowel inflammation as the gold standard; (2) prospectively test whether the thiopurine monitoring algorithms can accurately classify IBD patients who are immunosuppressed and patients who are non-adherent to thiopurine medications, and whether these algorithms can prospectively guide dosing of thiopurines in patients; and (3) implement these revised algorithms on a web server using the LIDDEx grid architecture to enable nationwide clinical use, and field test this implementation in the Ann Arbor VA IBD clinic.
CCFA (Herfarth) 7/1/11-6/30/14 (extension pending) 0.8 cal mo
Univ of North Carolina $18,000
CCFA Clinical Research Alliance
Role: Co-Chair
In 1999, CCFA launched the Clinical Research Alliance, a network of major medical centers and smaller, local facilities. These centers collaborate on clinical studies on the management and treatment of IBD: As a result, key studies are performed more efficiently and with larger groups of patients. Members propose and participate in clinical studies that are critical to understanding IBD and would likely not be funded otherwise.
Senior Research Award (Higgins) 1/1/13-12/31/15 1.08 cal mo
Crohn’s & Colitis Foundation of America $105,300
C. difficile infection induces changes in the gut microbiome that lead to IBD flares
These studies seek to identify patterns in the gut microbiome associated with UC flares
Centocor (Higgins) 4/1/10-12/31/14 <0.06 cal mo
$26,408
A phase 3 multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of golimumab maintenance therapy, administered subcutaneously, in subjects with moderately to severely active ulcerative colitis
This study evaluates the efficacy and safety of 2 SC administered regimens of golimumab in maintaining clinical response through Week 54 in subjects with moderately to severely active UC induced into clinical response with golimumab in the induction studies C0524T16 or C0524T17.
Centocor (Higgins) 1/6/11-6/30/14 (extension requested) <0.06 cal mo
$455,930
Prospective, Multicenter, Randomized, Double-blind, Placebo-Controlled Trial Comparing REMICADE ® (infliximab) and Placebo in the Prevention of recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence
The primary objective of this study is to compare the efficacy of infliximab with that of placebo in the prevention of clinical recurrence of CD through Week 76, defined as a composite endpoint that requires endoscopic confirmation of recurrence, in patients who are at an increased risk of active CD recurrence following ileocolonic resection.
Millenium (Higgins) 7/1/11-4/30/14 <0.06 cal mo
$38,025
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease
The primary objective is to determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha antagonist therapy
Millenium (Higgins) 8/1/11-7/31/16(extension requested) <0.06 cal mo
$43,204
Protocol C13008 - A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease
The primary objective of this study is to determine the safety profile of long term Vedolizumab treatment
Buhlman Laboratories (Higgins) 8/1/11-7/31/14 <0.06 cal mo
$167,683
Calprotectin ELISA Method comparison to predictive device for FDA clearance Study Protocol
The goal of this study is to develop a a method of comparison for a new calprotectin ELISA to the predicate device
Centocor (Higgins) 9/1/11 – 10/30/14 <0.06 cal mo
$36,306
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy Protocol CNTO1275CRD3001
The primary objective is to evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn’s disease who have failed or are intolerant to one or more tumor necrosis factor (TNF) antagonist therapies.
Centocor (Higgins) 1/17/12 – 10/30/14 <0.06 cal mo
$36,306
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Protocol CNTO1275CRD3002
The primary objective is to evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn’s disease.
Centocor (Higgins) 9/1/11 – 10/30/14 <0.06 cal mo
$36,306
A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Protocol CNTO1275CRD3003
The primary objective is to evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease induced into clinical response with ustekinumab in the induction studies, CNTO1275CRD3001 and CNTO1275CRD3002.
Abbott Laboratories (Higgins) 7/1/11-4/30/14(extension requested) <0.06 cal mo
$168,255
Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn’s Disease (CADHUM)
The primary objectives are to: 1) Determine whether adding as-needed q 12 weeks Adalimumab re-loading (160 mg/80 mg) when fecal calprotectin (FCP) ≥167 mcg/gram of stool can improve the maintenance of remission in Crohn’s Disease patients who stop Adalimumab therapy (PRNLOAD Arm). 2) Determine whether Crohn’s disease patients in remission on Adalimumab with FCP <167 mcg/gram of stool can safely stop Adalimumab therapy for up to 46 weeks (PBO Arm). 3) Compare remission rates of these two groups of patients to a third arm in which Adalimumab maintenance, 40 mg q 2 weeks, is continued (MAINT Arm).
Pfizer (Higgins) 5/1/12 – 4/30/14(extension requested) <0.06 cal mo
$45,644
A multicenter, double-blind, placebo-controlled, parallel-group study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis (OCTAVE induction study)
The Primary Objective of this study is to demonstrate the efficacy of CP-690,550 in inducing remission in subjects with moderately to severely active ulcerative colitis.
Pfizer (Higgins) 5/24/12 – 5/23/16 <0.06 cal mo
$35,195
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis (OCTAVE maintenance study)
The Primary Objective of this study is to demonstrate the efficacy of CP-690,550 as maintenance therapy in subjects with UC.
Pfizer (Higgins) 6/7/12 – 6/6/17 <0.06 cal mo
$42,840
A multicenter, open-label study of CP-690,550 in subjects with ulcerative colitis (OCTAVE open label study)
The primary objective of this study is to assess the safety and tolerability of long-term CP-690,550 therapy in subjects with UC.
Subcontract Mt Sinai School of Med (Croitoru PI) 10/1/12-6/30/15 <0.06 cal mo
CCFA (prime sponsor) $18,333
GEM Project-A Multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel Disease
The goal of this project is to recruit unaffected siblings and offspring of Crohn’s disease patients and prospectively measure environmental exposures, changes in enteric microbial flora and changes in immune responses in relation to the barrier function of the intestine and genetic makeup of these individuals in an attempt to identify the changes that determine who develops Crohn’s disease.
Role: Site PI
Siemens Medical Solutions (Dillman) 9/1/12-11/1/14 0.06 cal mo
$19,228
ACUSON S2000/S3000 Contrast Imaging
The purpose of the proposed study is to determine if contrast-enhanced ultrasound can discriminate acutely inflamed from fibrotic bowel segments in a Crohn disease animal model.
Role: Co-I
Bracco Diagnostics, Inc. (Dillman) 03/01/2013 – 07/31/2014 0.06 cal mo
$19,228
Study IIS-US-0095: Contrast-Enhanced Ultrasound Assessment of Inflamed vs. Fibrotic Bowel Segments in a Crohn Disease Animal Model
The goal of this research is to distinguish inflamed bowel segments from fibrotic bowel segments in a Crohn disease animal model based on patterns of contrast enhancement (and numerous other related parameters), independent of unenhanced grey-scale and Doppler imaging findings.
Role: Co-I
Coronado Biosciences (Higgins) 12/6/12-12/2/14 <0.06 cal mo
United BioSource Corp $150,151
A randomized, double-blind, placebo-controlled, multicenter, Phase II study to evaluate the efficacy and safety of 12 weeks of treatment with two different doses of oral CNDO 201 Trichuris suis ova suspension (TSO) as compared to placebo, followed by a 12 week open-label treatment period with TSO, in patients with moderately to severely active Crohn’s disease
The objectives of this study are to evaluate the efficacy and safety of two different doses of oral Trichuris suis ova suspension (TSO), as compared to placebo, in patients with moderately to severely active Crohn’s disease.
Pfizer (Higgins) 3/25/13-9/24/15 <0.06 cal mo
$83,618
A Double-Blind, Randomized, Placebo-Controlled, Parallel, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects with Moderate to Severe Ulcerative Colitis (TURANDOT)
The primary objective is to characterize the dose-response and efficacy of PF-00547659 in inducing clinical remission based upon Mayo Score in subjects with moderate to severe ulcerative colitis
AstraZeneca (Higgins) 6/5/13-10/17/15 <0.06 cal mo
$81,295
A Phase 2a Study to Evaluate the Efficacy 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
The primary objective is to evaluate the efficacy of MEDI2070 versus placebo to induce a clinical effect (defined as at least a 100-point reduction in Crohn’s Disease Activity Index [CDAI] from baseline) or remission at Week 8 in subjects with moderate to severe Crohn’s disease
Pfizer (Higgins) 9/1/13-8/31/17 <0.06 cal mo
$91,470
A Multicenter Open-Label Extension Study to Assess Long-Term Safety of PF-00547659 in Subjects with Ulcerative Colitis (TURANDOT II)
The primary objective of this study is to monitor the safety and tolerability of PF-00547659 during long-term treatment.
AbbVie (Higgins) 10/1/13-9/30/14 <0.06 cal mo
$35,711
A Multicenter Study Evaluating a PRactical IndEx Score for Subjects with Chron’s DIsease Assessing the Absence of Mucosal UICeraTion (PREDICT)
The purpose of this study is to evaluate indices scores in a broader population of Crohn's disease, not limited by disease severity or concomitant therapy. Moreover, we plan to explore additional variables which may improve these indices scores in a heterogenic Crohn's disease population.
Amgen, Inc (Higgins) 12/1/13-11/30/17 <0.06 cal mo
$40,654
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease
The clinical hypothesis of this study is that AMG 181 70 mg is effective, compared to placebo, in inducing remission defined as a CDAI score < 150 after 8 weeks of treatment in subjects with moderate to severe Crohn’s disease
Pfizer, Inc (Higgins) 4/1/14-3/31/16 <0.06 cal mo
$20,549
A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease
The primary objective of the study is to estimate the effects of tofacitinib in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn’s disease previously achieving clinical response or remission in induction Study A3921083
Pfizer, Inc (Higgins) 1/2/14-12/31/15 <0.06 cal mo
$58,086
A randomized, double-blind, placebo-controlled, parallel fgroup, multi-centre study to investigate the safety and efficacy of CP-690,550 for inductiontherapy in subjects with moderate to severe Crohn’s disease
The primary objective of the study is to evaluate the dose-response of tofacitinib in inducing clinical remission in subjects with moderate to severe Crohn’s disease and to select effective dose(s).
AMAG Pharmaceuticals, Inc (Higgins) 3/1/14-7/31/14 <0.06 cal mo
$7,022
Renal failure rates in IBD patients and associated complications
This review will determine the renal failure rates of patients with Inflammatory Bowel Disease (IBD) and assess whether renal failure increases the risk of complications.
The Broad Foundation (Higgins) 4/1/14-3/31/16 0.12 cal mo
$99,159
Serum glycoproteome profiling to detect intestinal fibrosis in stricturing Crohn’s disease
The long-term goal of this line of research is a validated high throughput assay for detecting and quantifying intestinal fibrosis in CD.
CCFA (Osterman) 10/1/13-9/30/15 0.03 cal mo
Univ of Pennsylvania subcontract $4,200
Mucosal healing and relapse in quiescent ulcerative colitis: an exploratory study (MARQUEE)
The primary aims of this study are to determine the prevalence of active endoscopic mucosal disease and active histological disease in patients with clinically quiescent UC undergoing routine surveillance colonoscopy, both prior to and after stratification by baseline UC medication class.
AbbVie (Higgins) 6/24/14-5/31/16 <0.06 cal mo
$286,585
A Multicenter, Randomized, Double-Blind Study to 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 primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission defined as Crohn's Disease Activity Index (CDAI) < 150 at Week 4 and endoscopic improvement
AbbVie (Higgins) 8/1/13-7/31/24 no measurable effort
$21,924
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)
This is a non-interventional Registry study to evaluate the long-term safety and effectiveness of HUMIRA® as used in routine clinical practice in adult patients (18 years of age or older) with moderately to severely active UC, who receive anti-TNF therapy according to the local product label.
Janssen (Higgins) 1/1/14-12/31/17 <0.06 cal mo
$66,814
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseresponse Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis
The primary objectives are: 1. To evaluate the dose response of JNJ-54781532 at Week 8 in subjects with moderately to severely active UC. 2. To evaluate the safety of JNJ-54781532 in subjects with moderately to severely active UC.
PENDING
R01 (Higgins) 9/1/14-8/31/19 2.4 cal mo
NIH-NIDDK $538,857
Inhibiting Rho/MRTF-regulated intestinal fibrosis in models of Crohn’s Disease
The long-term objective of this research program is to develop, optimize, and test novel inhibitors of the Rho/MRTF/SRF pathway in vitro and in preclinical models of intestinal fibrosis
Pfizer, Inc (Higgins) 4/1/14-3/31/16 <0.06 cal mo
$20,309
An open-label extension study of CP-690,550 as maintenance therapy in patients with Crohn’s disease
The primary objective of the study is to assess the safety and tolerability of long-term open-label (OL) tofacitinib therapy in subjects with CD
Genentech, Inc (Higgins) 7/13/14-9/30/18 <0.06 cal mo
$159,101
Phase III, Double Blind, Placebo-Controlled Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis Who are Refractory to or Intolerant of TNF Inhibitors
This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the safety, efficacy, and tolerability of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of moderately to severely active UC.
CCFA (Higgins) 8/1/14-7/31/15 <0.06 cal mo
$100,000
A Randomized Controlled Trial of High Dose Vitamin D Therapy in Crohn’s Disease (RODIN-CD)
This study tests the hypothesis that high dose vitamin D supplementation among patients with deficiency (<20ng/ml) will lead to significant improvement in clinical outcomes compared to placebo.
OVERLAP
None
Completed Funding:
NIH R21 Grant (Rubin, PI)
12/1/08-11/30/10
Non-Invasive Ultrasound Elasticity Imaging (UEI) in Crohns Disease
Role: Co-Investigator
This study will investigate the potential of UEI to radically improve the diagnosis and timely management of intestinal fibrosis in Crohns Disease.
NIH K08 Grant 2 1K08DK080172-01 (PI: Higgins)
Project title:Mechanisms and Prevention of TGF-Beta-Induced Intestinal Fibrosis
Project Director: Peter Higgins, M.D., Ph.D., M.Sc.
Entire period of support: 2/1/08-1/31/11
The long-term research goal is to elucidate the mechanisms of TGFB1-driven intestinal fibrosis and to use this information to target anti-fibrotic therapies that can prevent or reverse intestinal fibrosis.
Genentech Investigator-Initiated Grant (PI: Higgins)
Project title: Development of Patient Reported Outcome Measures for Ulcerative Colitis and Crohns Disease
Project Director: Peter Higgins, M.D., Ph.D., M.Sc.
Entire period of support: 9/1/09-12/31/10
Total Direct Costs: $794,305
Centocor anti-IL12/23 UstekinumabStudy (PI: Higgins)
A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety, and intravenous induction of response and subcutaneous maintenance therapy with ustekinumab in patients with moderately to severely active Crohns Disease who have failed a previous anti-TNF therapy (including remicade, humira, or cimzia)
NIH T32 Medical Scientist Training Program, GM07171
National Institutes of Health
Training Program Director: Salvatore Pizzo, M.D., Ph.D.
Duke University
Entire period of support: 8/1987-5/1998
NIH T32 Training for Research in Gastroenterology, DK 007367-24
University of Michigan Gastroenterology Division
Project Director: Chung Owyang, M.D.
Entire period of support: 7/1/2002-6/30/2003
NIH T32 Program in GI Epidemiology and Outcomes, DK62708-01
National Institutes of Health
Project Director: Philip Schoenfeld, M.D., M.S., M.Ed.
NIH K30 Award for Clinical Research, HL004108
National Institutes of Health
Project Director: David Schteingart, M.D.
Entire period of support: 7/2003-6/2005
Munn Idea Awards in Colon Cancer Research
University of Michigan Cancer Center
Project title: Multi-agent Chemoprevention of Colon Polyps and Colorectal Cancer
Source of support: University of Michigan Cancer Center
Project Co-Directors: Peter Higgins, M.D., Ph.D.,
Philip Schoenfeld, M.D., M.S., M.Ed.,
Steven Gruber, M.D., M.P.H.
Entire period of support: 3/1/03-8/30/05
GCRC Research Funding
Project title: Lipitor In the Treatment of Ulcerative Colitis
Source of support: University of Michigan GCRC [GCRC Protocol #1884]
Project Co-Directors: Peter Higgins, M.D., Ph.D., and Ellen Zimmermann, M.D.
Entire period of support: 5/1/02-12/31/05
AGA Centocor Excellence in IBD Clinical Research Award
Detection of Enteric Fibrosis in Crohns Disease
American Gastroenterological Association
Project Director: Peter Higgins, M.D., Ph.D.
Entire period of support: 7/2004-6/2006
NIH K12 Award for Clinical Research, RR017607-01
National Institutes of Health
Project Director: David Schteingart, M.D.
Entire period of support: 1/1/2004-12/31/2006
Crohns and Colitis Foundation of America Senior Research Award
Project title: Development of a Novel Noninvasive Measure of Ulcerative Colitis
Project Director: Peter Higgins, M.D., Ph.D., M.Sc.
Entire period of support: 2/1/06-1/31/09
This study will rigorously establish a valid basis for the noninvasive assessment of the many new therapies being developed for ulcerative colitis so that the best therapies will be identified, developed, and made available to patients.
Otsuka Adacolumn Clinical Trials 205, 206, 207, 208
Adacolumn Apheresis for Ulcerative Colitis and Crohns Disease
Site PI: Peter Higgins, M.D., Ph.D.
Entire period of support: 8/1/05-12/31/07
ASGE Endoscopic Research Grant
Project title: Sheathed vs. Standard Forceps: Does it matter for obtaining uncontaminated biopsy specimens of microbiota from the terminal ileum?
Project Director: Peter Higgins, M.D., Ph.D., M.Sc.
This study will test the hypothesis that biopsy specimens obtained with standard forceps are more likely to be contaminated with colonic flora and stool, and not represent the true bacterial flora from the site where the specimen is obtained in comparison to sheathed biopsy forceps.
Novartis Pharmaceuticals anti-IL17 Study (Higgins)
3/24/08-12/31/09
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study to assess the efficacy, safety, and tolerability of two single iv infusions of AIN457A 10 mg/kg in patients with moderately to severely active Crohns Diseas.