The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing SpondylitisThis study uses colonic biopsies to compare immune cell function and gut microbiome between those with IBD, AS, AS/IBD overlap, and healthy controls. To evaluate the relationship between the colonic microbiome and the immune system in AS, IBD, AS+IBD, and healthy controls. Locations: Colorado Research Center; Denver Health Medical Center; University of Colorado Hospital |
Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease |
A PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF RSLV-132 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
- assess the impact of 13 IV infusions of RSLV-132 on cutaneous lupus disease activity using the CLASI activity score. -assess improvement in disease activity using SLEDAI-2K, BILAG-2004 and PGA; - evaluate the immunogenicity of RSLV-132 in subjects with SLE; - assess improvement in tender or swollen joint count; - assess improvement in patient reported outcomes using the FACIT-Fatigue scale; - assess the ability of subjects to reduce oral steroids at Day 169; ? evaluate the safety and tolerability of 22 weeks of RSLV-132 exposure; - assess the proportion of subjects achieving a 50% improvement in CLASI activity score - assess the following exploratory endpoints -- evaluate the impact of RSLV-132 treatment on gene expression profile; -- evaluate the impact of RSLV-132 treatment on autoantibody and complement profiles; -- evaluate the impact of RSLV-132 on serum protein levels; -- assess the impact of RSLV-132 on the CLASI damage score Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital |
Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)The Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS) is a registry proposed by the affiliate members of the University of Colorado Program to Advance Spondyloarthritis Treatment (U.C.PAST). The purpose of PIERS is to identify individuals at risk for spondyloarthritis and study these individuals in a longitudinal manner in order to better understand the development of spondyloarthritis. Results from this study may provide information that contributes to our understanding of the complex relationships among immune dysregulation, genetic risk, subclinical phenotypes, and established spondyloarthritis phenotypes.
Location: University of Colorado Hospital |
Calibrating free-living physical activity characteristics across functionally-limited populations using machine-learned accelerometer approachesRegular physical activity is known to have positive effects on many health outcomes. In research, physical activity is often measured using activity monitors worn on the hip, wrist or ankle. These instruments determine how much physical activity a person does based on the amount of movement the person does. This is done with equations that use the data collected by the activity monitors. However, these equations are usually developed using measurements on healthy people. People who have movement disorders related to diseases such as Parkinson?s and Multiple Sclerosis, or conditions such as knee replacement, stroke, or arthritis have very different movement patterns than people without these diseases. Thus, the equations used to convert activity monitor data will not work well in people with these diseases or conditions. The purpose of this study is to develop equations to measure physical activity using activity monitors in people with movement limitations. Rather than creating specific equations for each individual disease and condition, we will perform simple tests to measure upper and lower body function, and then group people into different clusters based on these tests. Our preliminary studies show that these equations are more accurate than equations based on specific diseases or conditions.
Locations: CTRC-adult; University of Colorado Hospital |
Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)This study is inviting people who have RA into a study to have an HRCT scan and PFT testing done for the study to learn more about lung disease in RA
Location: University of Colorado Hospital |
A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome |
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital |
Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA)
Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital |
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus |
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) |
Controlling and Preventing Asthma Progression and Severity in Kids with OmalizumabRandomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase
Location: Childrens Hospital Colorado |
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus |
Allen CU-UCSD Transition to RA Project: Blood and Flu |