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A Phase 3, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy
University of Colorado Hospital The study comprises of screening period that lasts upto 60 days and ends with the participant's randomization, the treatment period starts with the administration of first dose of study drug and lasts 12 months. Participants who complete the treatment period will be offered to enter a 12 m... |
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A Phase 1, Open-Label, Multicenter Study of KYV-101-001, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis
Outpatient CTRC, Renal Research Center, University of Colorado Hospital Apheresis (collection of white blood cells) followed by lymphodepletion (medications to weaken, temporarily, your immune system so that the CAR T cells can grow and work in the body, followed by single infusion of KYV-101 (the CAR T cells made specifically for your body)... |
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A Phase 1b, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants with Moderate to Severe Rheumatoid Arthritis who have Failed Prior Therapies
Barbara Davis Center, Cherry Creek Medical Center, CTRC Inpatient, University of Colorado Hospital Screening period (6 weeks): During this period, you will have screening tests and procedures done to see if you meet the requirements to be in this research study. The initial screening tests are planned to be done on a single day and may take a total of approximately 2-4 hours. Study Tr... |
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Program for Individuals with an Elevated Risk of Spondyloarthritis (PIERS)
University of Colorado Hospital 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 spondyloarthri... |
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Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017
Boulder Sports Clinic, University of Colorado Hospital This is an unblinded, multi-center, pragmatic randomized controlled clinical trial of operative versus non-operative treatments for atraumatic rotator cuff tears. A sample size of 700 patients will be enrolled with approximately equal numbers of patients randomized to operative treatment (... |
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The Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome: A Pilot Study
University of Colorado Hospital The results of the ultrasound will help determine if there are any significant radiologic findings or patterns seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle compa... |
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A 2-and-5-year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with or without additional stabilization using the coflex® ® Interlaminar Technology for FDA Actual Conditions of Use Study.
Highlands Ranch Hospital, University of Colorado Hospital The first objective addresses coflex® performance in actual conditions of use settings at two years and at five years relative to pivotal trial device performance. The second objective compares coflex® performance in actual conditions of use settings to decompression alone using data from ... |
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3
Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic
Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Barbara Davis Center, University of Colorado Hospital This study will last upto 48 weeks with three drug intervention. One group receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059 subcutaneously every 4 weeks upto 48 weeks. Second group receiving background nonbiologic lupus SOC therapy will receive low dose ... |
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In-Office NanoArthroscopy: Evaluation of Indications, Outcomes, and Cost-Effectiveness ? A Pilot Study
Boulder Sports Clinic, CU Sports Medicine - Denver, UCHealth Steadman Hawkins Clinic - Denver (Inverness), University of Colorado Hospital NanoScope procedure takes approximately 5-10 minutes in total, is essentially identical with respect to the technique required to perform an in-office knee injection (i.e. steroid injection), and is associated with equal (or less) risk to the patient as compared to an in-office knee inject... |
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Classification of Axial Spondyloarthritis Inception Cohort (CLASSIC) study
Barbara Davis Center, Rocky Mountain Regional VA Medical Center, University of Colorado Hospital The ASAS group has developed classification criteria for axial spondyloarthritis (axSpA) that allow the inclusion of patients with an early form of disease that is not yet clearly visible on plain radiography. These criteria include both an "imaging arm," that incorporates either radiograp... |
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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis
University of Colorado Hospital What happens at the study visits? Screening: You will receive screening health assessments to confirm if you qualify to join the trial. You will answer questions about your medical history, symptoms, and current medications. Joint Biopsy: You will have a biopsy of your joints once durin... |
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Skeletal Response to Simulated Night Shift (SPOTLIGHT Study)
CTRC Inpatient, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital What is involved: • Measurements of bone mineral density • Completion of sleep questionnaires/assessments • Randomization to sleep with a simulated night shift schedule or normal sleep schedule • A general physical exam • Activity monitoring with a wrist monitor • Blood/urine collec... |
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Study of inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA
University of Colorado Hospital In this research study we want to learn more about rheumatoid arthritis (RA). Some people with rheumatoid arthritis develop a related condition called RA-associated interstitial lung disease (RA-ILD). We are doing this study to understand why some people with RA develop RA-ILD and others d... |
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A Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Contiguous Two-Level Symptomatic Cervical Radiculopathy
Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6- C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopat... |
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Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
CU Sports Medicine - Denver, Department Specific Free Standing Clinic, UCHealth Central Park Medical Center During this study, we will enroll n=48 total subjects who have recently sustained an mTBI. Subjects will be randomized to one of two study groups, followed throughout the duration of the 8-week vNDT intervention period, returned for post-intervention period testing, and then followed via m... |
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Study of the Association between Cellular Processes in the Lung & Blood and Patient Health in Individuals with Rheumatoid Arthritis with and without Evidence of Interstitial Lung Disease
Barbara Davis Center, University of Colorado Hospital This study involves blood tests, sputum collection, physical exams, and questionnaires; it may also involve pulmonary function tests (PFTs) and a high-resolution computed tomography (HRCT) scan of your lungs. PFTs involve breathing into a tube to determine any lung abnormalities while HRCT... |
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A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled
Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
Barbara Davis Center, University of Colorado Hospital This is a Phase 3b/4 multicenter study that includes 2 periods. Period 1 is a 12-week randomized, double-blind, double-dummy, active comparator-controlled period designed to compare the efficacy and safety of upadacitinib (15 mg QD) + MTX versus dalimumab (40 mg eow) + MTX in adult subjec... |
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A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)
Outpatient CTRC This is a Phase 2s multicenter randomized study to evaluate the efficacy, safety and tolerability of GS-5178 in participants with Cutaneous Lupus Erythematosus. Participants who meet eligible criteria will be randomized in a 2:1 ratio to one of the two treatment groups: GS-5178 2 15mg tabl... |
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Accelerating Medicines Partnership:
Autoimmune and Immune-Mediated Disease (AIM) Rheumatoid Arthritis
Barbara Davis Center, University of Colorado Hospital If you participate you will be asked to come in for a screening to determine eligibility for a synovial biopsy of your wrist, knee, or ankle. You will also be asked to complete health questionnaires and have your blood drawn. You may be compensated up to $305 for completion of 3 visits ove... |
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A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (pegloticase) Administered Every 4 Weeks Compared with KRYSTEXXA Administered Every 2 Weeks with Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants with Uncontrolled Refractory Gout (FORWARD II)
Barbara Davis Center, University of Colorado Hospital The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout... |
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Prospective Clinical Assessment Study in Children with Hypochondroplasia: ACCEL
Childrens Hospital Colorado This is a prospective, non-interventional clinical assessment study to collect data on children aged 2.5 to <17 years with HCH, which will contribute to the characterization of the natural history of children with HCH. This study is designed to evaluate study participants over a period of... |