Past Projects
ASSET: A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
(ASSET)
Principal Investigator: Dinesh Khanna, MD, MS
Sponsor: Bristol-Myers Squibb and National Institute of Allergy and Infectious Diseases
(NIAID)
This study was a randomized, placebo-controlled, double-blind phase 2 trial of patients
with diffuse cutaneous systemic sclerosis (dcSSc). Eligible participants were randomized
in a 1:1 ratio to either 125 mg SC abatacept or matching placebo, stratified by disease
duration (<18 months vs >18 to ≤36 months). Study participants were treated for 12
months with double-blind study medication, followed by an additional 24 weeks of open-label
SC abatacept therapy. Eighty-six patients were randomized at approximately 35 centers
in the US, Canada, and Europe, with the goal of analyzing 74 participants. The investigators
tested whether abatacept was statistically superior to placebo in reducing the MRSS
at month 12 and explored the ability of abatacept to prevent or reverse progression
in patients with early disease duration and lower MRSS scores, as well as reverse
established disease in patients with longer disease duration and higher MRSS scores.
BASIC: The Brain Attack Surveillance in Corpus Christi Project
Principal Investigators: Lynda D. Lisabeth, PhD, MPH and Lewis B. Morgenstern, MD
Sponsor: National Institutes of Health (NIH)
The Brain Attack Surveillance in Corpus Christi (BASIC) project is an ongoing stroke
surveillance study that began in 1999. SABER began providing data management and programming
services to support this study in 2014. BASIC is the only ongoing stroke surveillance
project focusing on Mexican-Americans. Since the inception of this project, over 5,000
cerebrovascular disease patients have been followed.
BASIC: Cognitive
Principal Investigator: Lewis B. Morgenstern, MD
Sponsor: National Institutes of Health (NIH)
This study uses door-to-door surveillance in Nueces County, Texas, a non-immigrant,
bi-ethnic community, to determine the prevalence and trajectory over time of cognitive
impairment and dementia in Mexican-Americans and non-Hispanic whites. The study will
evaluate the roles of vascular disease risk factors, educational attainment and socio-economic
status, community resources, and caregiving roles to examine ethnic disparities. SABER
provides data management and programming for this study.
BASIC: Outcomes Among Surrogate Decision Makers In Stroke (OASIS)
Principal Investigators: Darin Zahuranec, MD and Lewis B. Morgenstern, MD
Sponsor: National Institutes of Health (NIH)
Often, people with stroke need help from another person to make decisions about important
medical treatments. However, we know very little about the experience and outcomes
of these family members who make medical decisions for a loved one with a stroke.
This study aims to answer important questions about how doctors communicate with family
decision-makers during these difficult times, how people make decisions for stroke
patients, and the long-term impact on those who serve as decision-makers for stroke
patients. SABER provides data management and programming for this study.
BASIC: Sleep Studies
Principal Investigators: Devin L. Brown, MD, MS and Lynda D. Lisabeth, PhD, MPH
Sponsor: National Institutes of Health (NIH)
The University of Michigan Stroke Program investigates multiple aspects of post-stroke
sleep apnea in patients in Corpus Christi, Texas. (1) An NHLBI-funded ancillary study
assessed the frequency of sleep-disordered breathing after stroke, and the relationship
of this sleep disorder to stroke outcomes. (2) The NINDS-funded sleep apnea study
is designed to investigate health disparities related to sleep apnea in stroke patients.
(3) An NHLBI-funded ancillary study investigates the association between nocturnal
rostral fluid shifts and sleep apnea severity. (4) Finally, an NINDS-funded longitudinal,
population-based study of sleep apnea and stroke outcomes is performed to improve
the identification and management of important sleep apnea after stroke, provide critical
data to plan future clinical trials, and explore a potential target to reduce an important
ethnic health disparity. SABER provides data management and programming for these
studies.
CAPTURE: Validating a Unique COPD Case Finding Tool in Primary Care
Principal Investigators: Fernando Martinez, Weill-Cornell and Meilan Han, University
of Michigan
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
CAPTURE is a large prospective study which explores the impact of the CAPTURE screening
tool for COPD on clinical care and patient outcomes across a broad range of primary
care settings in a cluster randomized controlled clinical trial. The study will enroll
approximately 5,000 patients across 100 participating primary care clinics associated
with practice-based research networks (PBRNs). Participants will be assessed with
the CAPTURE tool and have research spirometry testing. The tool will be compared against
the spirometry testing. In addition, participating primary care practices will be
randomized in a 1:1 fashion to receiving either a general COPD education module, or
a COPD module that includes training on the use of the CAPTURE tool, to assess the
12-month impact on patient outcomes.
COMET: Correlating Outcomes with biochemical Markers to Estimate Time-progression
in IPF. A Prospective, Multi-Center, Longitudinal Follow up Study of Subjects with
Idiopathic Pulmonary Fibrosis.
Principal Investigators: Kevin R. Flaherty MD, MS; Fernando J. Martinez MD, MS; Galen
B. Toews, MD
Sponsor: National Institute of Health (NIH)
This prospective cohort study aimed to identify optimal biomarkers of disease progression
in patients with recently diagnosed idiopathic pulmonary fibrosis (IPF). Clinical
centers collected biologic samples from subjects and followed them for at least 48
weeks. Biomarkers from multiple compartments, including blood, lung biopsies, and
lavage, were integrated with longitudinal measures of disease progression such as
changes in lung function, acute exacerbations, and survival. The study took place
in two phases: initial collection of baseline samples, followed by ongoing follow-up
for up to 80 weeks. Subjects were monitored until the study’s end or until reaching
a composite endpoint like significant lung function decline, acute exacerbation, or
death. No specific treatment was assigned; subjects could continue their physician-prescribed
therapies, including participation in clinical trials. This research supports better
understanding of IPF progression and paves the way for future biomarker-driven interventions.
EMERGE: Emergency Medicine Education and Research by Global Experts
Principal Investigator: Prashant Mahajan, MD, MPH, MBA
EMERGE is a pilot project to develop an international network of experts in emergency
room departments to collaborate in research and share emergency medicine-related education.
SABER is assisting this project by developing a combined dataset derived from electronic
medical records from 10 countries (and counting) to describe the departments in each
country, to answer research questions, and to create a platform for prospective research
initiatives. As the project evolves from pilot stage, SABER will provide project management,
software development, and statistical analysis support for its clinical research initiatives.
First X: A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens
of Oral CXA-10 in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS)
Sponsor: Complexa, Inc.
The study was performed at approximately 25 sites. The core study was a multicenter,
open-label, randomized study investigating two dose titration regimens of CXA-10 in
subjects ≥13 years of age with primary FSGS. With the implementation of protocol amendment
4, the study was no longer randomized, and all subjects enrolled under amendment 4
were assigned to the 150 mg starting dose titration regimen. With the implementation
of protocol amendment 5, an additional high dose cohort was added.
MANAGE HF: A Multifaceted Adaptive Mobile Application to Promote Self-Management and
Improve Outcomes in Heart Failure
Principal Investigator: Michael Dorsch, PharmD, MS
Sponsor: National Institute on Aging (NIA)
Manage HF is a phase 3, multicenter, 12 week, randomized, and double-blind clinical
trial. This study will investigate the effectiveness of two contextual just-in-time
adaptive interventions (JITAIs) delivered via a mobile app for patients with heart
failure. The clinical worsening intervention targets self-management of behaviors
to prevent worsening of a patient’s heart failure symptoms. The dietary sodium intervention
promotes lower sodium intake. Eligible participants will be randomized to the dietary
sodium intervention, the clinical worsening intervention, both interventions, or no
intervention in a 1:1:1:1 manner, stratified by site, gender, and heart failure type
(HFpEF versus HFrEF).
MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
Principal Investigator: Riann Palmieri-Smith, PhD
Sponsor: National Institute of Child Health and Human Development (NICHD)
This study is a single-center, randomized, double-blind, placebo-controlled, and parallel-group
clinical trial to examine the combined efficacy of neuromuscular electrical stimulation
(NMES) and eccentric exercise (ECC) to promote the recovery of quadriceps strength,
improve physical and biomechanical function, and reduce the risk of post-traumatic
osteoarthritis (OA) after anterior cruciate ligament rehabilitation (ACLR).
MOIDS: Missed Opportunities for Improving Diagnosis in Pediatric Emergency Care
Principal Investigator: Prashant Mahajan, MD MPH MBA
Sponsor: Agency for Healthcare Research and Quality (AHRQ)
MOIDS is an observational study to test an electronic health record (EHR) algorithm
for identifying missed opportunities for diagnosis. The EHR-based algorithm and non-EHR
measures will be reviewed across 5 pediatric emergency departments retrospectively
and iteratively to refine the algorithms. Then the refined and tested algorithms will
be applied to all pediatric ED visits at the sites prospectively. Expert reviewers
will then assess all identified cases for judgment on whether the cases are missed
opportunities, reviewing patient-related factors, patient-provider interactions, diagnostic
tests, follow-up and tracking of diagnostic information, and referrals. Inter-rater
reliability will be assessed. Frequency of MOIDS and characteristics associated with
MOIDS will be assessed, along with the performance characteristics of the algorithm.
SABER provides data management and statistical support for this study.
PERL: A multicenter clinical trial of allopurinol to prevent GFR loss in type 1 diabetes
Principal Investigator: Alessandro Doria, MD PhD MPH
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
and Juvenile Diabetes Research Foundation (JDRF)
The study was a multi-center, double-blind, placebo-controlled, parallel-group randomized
clinical trial that included a total of 480 patients with type 1 diabetes (T1D) who
were at high risk for GFR loss because of increased albuminuria and a relatively high
serum UA (≥4.5 mg/dl), but had only mildly or moderately decreased renal function.
PFDN:
The Pelvic Floor Disorders Network (PFDN) is a cooperative network of investigators
from seven clinical centers and the Data Coordinating Center (DCC). The primary goal
of the PFDN is to improve the level of knowledge about pelvic floor disorders (such
as
pelvic organ prolapse, urinary incontinence, and fecal incontinence) in women. The
PFDN is supported by cooperative agreements from the National Institute of Child
Health and Human Development (NICHD).
RESCUE: A Multi-Center Randomized, Double-Blind, Placebo-Controlled Pilot Study To
Assess The Efficacy And Safety Of Riociguat In Scleroderma-Associated Digital Ulcers
Principal Investigator: Dinesh Khanna, MD
Sponsor: Bayer
RESCUE was a multi-center randomized, double-blind, placebo-controlled pilot study
to assess the efficacy and safety of riociguat administered 3 times daily (TID) in
comparison to placebo in patients with scleroderma-associated digital ulcers. The
trial was a 16 week double blind study, followed by a 16 week open label extension.
Additional efficacy measures included improvement of Raynaud’s phenomenon, presence
of digital ischemia requiring intravenous prostacyclin or digital gangrene or amputation,
and measurement of vascular biomarkers in the plasma. Five sites were selected to
enroll 20 participants.
SLSIII: Scleroderma Lung Study
Principal Investigator: Dinesh Khanna, MD, MSC
Sponsor: Bristol Myers Squibb (BMS)
SLS III is an investigator-initiated clinical research study focused on examining
the combined anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for
treating sclerodera-related interstitial lung disease. This research tests whether
combining pirfenidone and mycophenolate will result in a more rapid and possibly greater
improvement in lung function than when mycophenolate is used alone. While both of
these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat
other medical conditions, neither drug has been FDA-approved for the treatment of
scleroderma-related lung disease. SABER provides project management, clinical monitoring,
data management, software programming, and statistical analysis for this study.Content
SmartHF: Self-care Management Intervention in Heart Failure (SMART-HF): A Multicenter
Randomized Controlled Trial
Principal Investigator: Michael Dorsch, PharmD, MS
Sponsor: AHRQ (Agency for Healthcare Research and Quality)
The SmartHF study is a multicenter 12-week prospective randomized controlled clinical
trial. This study will investigate the effectiveness of an adaptive web application
to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF patients.
Eligible participants will be randomized to the web application intervention or control
in a 1:1 manner, stratified by site. The primary outcome is change in GDMT medication
quality score generated by the computable algorithm from baseline to Week 12. SABER
provides statistical analysis for this study.
SOUL MUSIC
Principal Investigator: Khurshid Ghani, MBChB, MS, FRCS
Sponsor: PCORI
The objective of this study was to compare patient outcomes following Stent Omission
(vs placement) after Ureter oscopy and Lithotripsy (SOUL), as previously defined using
RAND Appropriateness Methodology. The combined randomized and observational trial
design assessed outcomes and preferences in all patients. We hypothesized that patients
undergoing stent omission would have improvements in PROs and 30-day healthcare utilization.
TRAIL 1: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability
and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung
Disease
Principal Investigator: Ivan Rosas, MD
Co-Principal Investigator: Hilary Goldberg, MD, MPH
Sponsor: Genentech, Inc.
This was a phase 2, randomized, double-blind, placebo-controlled trial of pirfenidone
for the treatment of RA-associated interstitial lung disease. Approximately 270 subjects
were randomized to receive pirfenidone 2403 mg per day or placebo in a 1:1 ratio.
The primary aim of the study was to assess the efficacy and safety of pirfenidone
2403 mg/day versus placebo in patients with RA-associated interstitial lung disease.
The primary efficacy outcome was defined by a composite endpoint of decline from baseline
in percent predicted FVC of 10% or greater, or death during the 52-week treatment
period. Patients received blinded study treatment from the time of randomization until
the Week 52 Visit.
Udall: The University of Michigan Udall Center of Excellence for Parkinson's Disease
Research
Principal Investigators: Roger Albin, MD
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Up to 70% of patients with Parkinson's disease fall each year, quadrupling the rate
of hip fractures, leading to extended hospitalizations, increased use of skilled nursing
facilities and eventual nursing home placement. UM scientists have developed breakthrough
evidence that these falls, which are resistant to currently available treatments,
arise from the degeneration of brain cells that use the neurochemical acetylcholine.
By integrating neuroimaging, behavioral and pharmacological studies in patients with
Parkinson's disease and in animal models, we aim to further dissect the relationship
between falls and abnormalities in these brain cells, and to develop the data necessary
to launch a clinical trial of a novel treatment for these debilitating symptoms of
Parkinson's disease. SABER acts as the biostatistics and data management center for
this series of studies.