The Center for Orthopaedic’s Research Department is dedicated to conducting high quality clinical research studies in multiple therapeutic areas of medicine. The department specializes in phase II, III, and IV clinical trials for the pharmaceutical and biotechnology industries. The goal of the department is to aid in the development of devices and drugs, by helping to generate new findings that will improve the quality of life for patients, and bring new effective treatments to the market.
The department has dedicated research coordinators that are integral to each study. The coordination of the department is overseen by a director that has 20 years’ experience in conducting industry sponsored trials. The Principal Investigators responsible for the studies provide the coordinators with oversight and support, to ensure the promotion of patient safety and production of quality data for each trial.
We are a metrics driven site that is able to deliver quick study start-ups and meet stringent sponsor deadlines without compromising data integrity. Imperial Health is able to utilize the services of central institutional review boards (IRBs) for protocol approval and oversight; allowing for a more expedited process. The department has an outstanding patient retention rate among the studies conducted at the site, which has been boasted by industry sponsors.
The orthopaedic research takes place in a state of the art 41,000 square foot facility located on 75 acres of land that is continually being developed. The facility is also home to Imperial Health’s Imaging Center and RehabOne, an orthopedic and sports medicine physical therapy group. We are located off Interstate 210, which loops from Interstate I-10, providing easy accessibility to patients in the vast surrounding areas. For sponsors and clinical research organizations (CROs), the Lake Charles Regional Airport is 5 miles from the facility.
Our orthopaedic physicians participate in multiple community events throughout the year spreading awareness on various musculoskeletal topics. Some of these events include health fairs, sponsorships, educational seminars and other charitable events as a means of giving back to the community. Word of mouth has been our best advertisement regarding the exceptional experience patients have had with our organization. We will continue to strive to meet the needs of our patients, while remaining on the cutting edge of medical breakthroughs.
Current Studies
Study Name: A Phase 3, Multicenter, Randomized, 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.
Sponsor: Idorsia Pharmaceuticals Ltd.
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT05672576
Status: Recruiting
Brief Summary: The goal of this clinical trial is to see how well cenerimod is in reducing symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are: How well cenerimod works on top of the treatment already being administered. How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered.
Study Name: Vectra InVolved Informed Decision Outcome Study (VIVID): A Prospective Randomized Controlled Trial Evaluating the Effect of Guided Care with Vectra Compared to Treatment as Usual in Patients with Rheumatoid Arthritis.
Sponsor: Sequenom, Inc.
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT03631225
Status: Recruiting
Brief Summary: The goal of treating patients diagnosed with rheumatoid arthritis (RA) is to achieve remission or low disease activity and thereby prevent joint damage, loss of physical function, and disability. Optimal management requires regular assessment of disease activity, with treatment changes made as needed for optimal efficacy. Vectra is a blood serum test that looks at 12 biomarkers and produces a score on a scale of 1 to 100. The Vectra score has been shown to be the strongest predictor of risk for progression of disease. There is an opportunity to gain more information about the utility of Vectra in a real-world clinical setting. This study will, therefore, evaluate the utility of Vectra for guiding treatment decisions and improving RA-related outcomes in comparison with usual care, which will not include Vectra testing. This study will enable a direct evaluation of the clinical benefit associated with using Vectra to guide treatment decisions in patients with RA.
Study Name: A Phase I/III Randomized, Double-Blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-Exposure Prophylaxis of COVID 19 in Participants with Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19.
Sponsor: AstraZeneca
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT05648110
Status: Recruiting
Brief Summary: AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre-exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. Sub-study: This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.
Study Name: A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg With Placebo in Patients with Active Lupus Nephritis.
Sponsor: Kezar Life Sciences, Inc.
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT05781750
Status: Recruiting
Brief Summary: The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN). This study aims to investigate whether zetomipzomib, added to standard of care treatment in patients with active LN, is able to reduce disease activity over a treatment period of 52 weeks. The background standard of care therapy will be mycophenolate mofetil (MMF) and initial optional treatment with IV methylprednisolone, followed by a tapering course of oral corticosteroids. Patients are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Patients will be randomized in a 2:1 ratio to receive either zetomipzomib (30 mg or 60 mg) or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up period. Efficacy will be assessed by measuring the level of proteinuria (as measured by urine protein to creatinine ratio [UPCR]) and estimated glomerular filtration rate (eGFR) as compared to current standard of care treatment. Safety will also be assessed throughout the study to ensure an acceptable safety profile.
Study Name: Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis.
Sponsor: XBiotech, Inc.
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT05363891
Status: Recruiting
Brief Summary: Natrunix will be assessed in combination with MTX (+folate) to determine the ACR 50 response rate. A total study population of 150 subjects with 1:1 randomization (75 subjects receiving Natrunix with MTX (+folate) and 75 receiving placebos with MTX (+folate)). The study duration is 17 weeks (4-week maximum screening + 12-week treatment period + 1-week follow up). Patients will undergo a preliminary assessment for study eligibility. Patients who meet the eligibility criteria will be screened and be required to provide an informed consent to acknowledge understanding and accept enrollment in the clinical study. Subjects enrolled will be randomized in a 1:1 ratio to receive either test article or placebo + MTX (+folate). Four weeks are allotted to complete all screening procedures. During the screening period, certain treatments will be washed out (discontinued), as applicable, according to eligibility requirements. Clinical assessments, collection of blood samples for Natrunix pK determination or other analysis will be performed at specified clinic visits. Natrunix + MTX + folate OR placebo + MTX + folate will be administered weekly for 12 weeks. After 13 weeks (about 3 months), the study will conclude. All data must be entered into the database in a timely manner, including data from the last visit. The primary endpoint for the study will be comparing the ACR 50 response between the subjects receiving Natrunix versus those receiving placebo.
Study Name: Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus
Sponsor: Amgen, Inc.
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT04680637
Status: Completed
Brief Summary: This is a phase 2b dose-ranging study to assess the efficacy and safety of efavaleukin alfa (AMG 592) in subjects with active SLE. Efavaleukin alfa may be a viable treatment option for SLE patients who are not responding to current standard of care (SOC).
Study Name: A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects with Active Psoriatic Arthritis.
Sponsor: Takeda
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT05153148
Status: Completed
Brief Summary: This is a Phase 2b, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Multiple Dose Study. Randomization to one of the treatments with NDI-034858 Dose 1, 2, 3 or placebo once daily (QD) will be based on a 1:1:1:1 scheme. The maximum study duration per subject is approximately 20 weeks, including up to 30 days for the screening period, a 12-week treatment period, and a 4-week safety follow-up period. Efficacy will be assessed using the ACR20 composite measure (including tender and swollen joint count, patient assessment of PsA pain visual analog scale (VAS), patient global PsA assessment VAS, physician global PsA assessment, HAQ-DI, and hsCRP) as well as the additional components. Efficacy for psoriasis among subjects who have ≥ 3% BSA) involvement on Day 1, will be measured using PASI, PGAs, and BSA. Safety will be assessed by collecting AEs, recording vital signs, performing physical examinations, and evaluating clinical laboratory and ECGs results.
Study Name: A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants with Systemic Lupus Erythematosus.
Sponsor: UCB Biopharma SRL
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT04976322
Status: Active, recruitment by invitation
Brief Summary: This is a multicenter, open-label extension (OLE) study to assess the long-term safety, tolerability, and efficacy of dapirolizumab pegol (DZP) on systemic lupus erythematosus (SLE) disease activity in eligible participants with SLE who complete a Phase 3 parent study (SL0043 or SL0044) without premature study withdrawal. Enrollment in SL0046 will allow study participants from the parent studies to receive DZP over 104 weeks and to be cared for in accordance with standard of care (SOC) practices after the completion of the parent studies. Participants must have completed one of the parent studies within 4 weeks prior to entry to this study. The primary safety outcome measures and secondary efficacy assessments included in this study are consistent with those used for other SLE studies and are considered appropriate for establishing safety and describing long-term efficacy of DZP.
Study Name: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants with Moderately to Severely Active Systemic Lupus Erythematosus.
Sponsor: UCB Biopharma SRL
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT04294667
Status: Active, not recruiting
Brief Summary: Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease which can present with a chronic disease course but has more often a relapsing-remitting disease course. The majority of patients develop tissue and organ damage over time with current standard of care (SOC) medication due to either lack of well-controlled disease activity or due to toxicities of the SOC medications. Therefore, new therapies are needed to achieve long-term control of the disease activity of SLE with well-tolerated SLE medication. The study aims to evaluate the efficacy of dapirolizumab pegol (DZP) in study participants who have persistent active or frequently relapsing-remitting SLE with moderate to severe disease activity despite being on stable non-biological SOC medication and therefore have an unmet medical need for a treatment intervention with new therapies.
Study Name: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis.
Sponsor: Eli Lilly and Company
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT03915964
Status: Active, not recruiting
Brief Summary: Rheumatoid arthritis (RA) is a common, systemic autoimmune inflammatory disease, characterized by synovial inflammation leading to pain, swelling, stiffness, and progressive destruction and deformity of small and large joints. Patients with RA experience impaired physical function, social participation, and health-related quality of life. These patients also have increased risk for significant non-musculoskeletal comorbidities. Baricitinib is an oral, reversible, selective inhibitor of Janus kinase (JAK)1 and JAK2 (Fridman et al. 2010). In Phase 3 studies involving patients with moderately to severely active RA, baricitinib 2-mg and 4-mg once daily showed significant improvements versus placebo across relevant domains of efficacy including signs and symptoms, low disease activity and remission, physical function, other patient-reported outcomes, and radiographic progression of structural joint damage. The 4-mg dose also showed significant improvements in relevant disease measures versus oral and injectable standard of care comparators (methotrexate [MTX] and adalimumab used with background MTX, respectively). Based on the assessment of benefit/risk, baricitinib has received approval for the treatment of RA from regulatory authorities in countries including the member states of the European Union (EU), Japan, and the United States of America (USA). In addition to the information collected in the pre-approval clinical development program, several post-approval studies are being conducted to further characterize the safety profile of baricitinib in patients with RA. These include prospective and retrospective observational studies, some involving well-established RA registries, and studies using administrative claims databases. As part of these dedicated pharmacovigilance activities, the present study is being conducted using a randomized, active comparator-controlled design to evaluate the safety of baricitinib in patients with RA.
Study Name: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis.
Sponsor: Eli Lilly and Company
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT05516758
Status: Completed
Brief Summary: This study aims to find the appropriately safe and effective dose and dosing frequency for peresolimab in adults with moderately-to-severely active rheumatoid arthritis (RA) for further clinical development.
Study Name: A Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1).
Sponsor: Sun Pharmaceutical Industries Limited
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT04314544
Status: Completed
Brief Summary: This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in subjects with active PsA and prior anti-TNF agent exposure. The study will be multinational and performed in approximately 100-200 study centers.
Study Name: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naïve Subjects with Active Psoriatic Arthritis II (INSPIRE 2).
Sponsor: Sun Pharmaceutical Industries Limited
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT04314531
Status: Completed
Brief Summary: This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA.
Study Name: An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients with Psoriatic Arthritis.
Sponsor: Sun Pharmaceutical Industries Limited
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT04991116
Status: Active, recruitment by invitation
Brief Summary: An open label phase 3 study. Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
Study Name: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients with Rheumatoid Arthritis (RA).
Sponsor: Viela Bio (acquired by Horizon Therapeutics)
Principal Investigator: Enrique Mendez, MD
ClinicalTrials.gov Identifier: NCT04163991
Status: Completed
Brief Summary: The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA). The overall study period will be approximately 337 days. After a screening period of up to 28 days, the participants will be randomized in a 1:1:1:1:1 ratio to receive intravenous dose of VIB4920 and/or placebo in 5 cohorts. Participants are to be followed on their stable background anti-RA therapy at least through 12 weeks (Day 85), at which time rescue therapy may be instituted. All participants will be followed through at least the primary (interim) analysis (Day 113), and those who have not instituted rescue therapy will be followed through Day 309 to determine the duration of clinical response. The primary analysis will be after all participants have completed Day 113, and the final analysis will be after all participants have completed follow-up.
Study Name: BIRMINGHAM HIP Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing.
Sponsor: Smith & Nephew
Device Name: BIRMINGHAM HIP Resurfacing (BHR) System
Principal Investigator: John Noble Jr., M.D.
ClinicalTrials.gov Identifier: NCT00611585
The purpose of the BIRMINGHAM HIP Resurfacing (BHR) Clinical Study is to collect additional information on the performance of this particular type of hip implant device. This is a 10 year study.
The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint replacement. The BHR system spares more of the hip joint bone compared with the total hip replacement devices.
Imperial Health Center for Orthopaedics is 1 of 7 sites participating in this study across the country. We are the only site in Louisiana, as well as the only southern gulf coast state participating in the study. The first patient enrolled at Center for Orthopaedics was in October 2007. Enrollment at this site closed in March 2011.
Study Name: A Prospective, Post Market, Multi-Center Study of the Tritanium® Primary Acetabular Shell.
Sponsor: Stryker Orthopaedics
Device Name: Tritanium® Acetabular Shell
Principal Investigator: John Noble Jr., M.D.
ClinicalTrials.gov Identifier: NCT01063751
The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Tritanium® Acetabular Shell as compared to the success rate of similar competitive devices as reported in scientific journals. This is a 10 year study.
Imperial Health Center for Orthopaedics is 1 of 8 sites participating in this study across the country. We are the only participating site in Louisiana. The first patient enrolled at Center for Orthopaedics was in July 2011. Enrollment at this site closed in November 2015.
Study Name: A Prospective, Post-Market, Multi-Center Study of the Outcomes of the
Triathlon Tritanium Knee System.
Sponsor: Stryker Orthopaedics
Device Name: Triathlon Tritanium Tibia and Patella
Principal Investigator: John Noble Jr., M.D.
ClinicalTrials.gov Identifier: NCT02155712
The purpose of this study is to learn if the Triathlon Tritanium cementless knee replacement works as well as a cemented knee replacement. This study has two groups: Cohort Group 1 and Cohort Group 2.
Group 1 is made up of patients who get the Triathlon Tritanium cementless knee replacement. Patients in this group will be followed for 10 years.
Group 2 is made up of patients who get a Triathlon CR or PS cemented knee replacement. Patients in this group will be followed for 5 years.
Imperial Health Center for Orthopaedics is 1 of 10 sites participating in this study across the country. We are the only participating site in Louisiana. The first patient enrolled at Center for Orthopaedics was in May 2015. Enrollment at this site closed in December 2016.
Study Name: A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the Trident II Tritanium Acetabular Shell.
Sponsor: Stryker Orthopaedics
Device Name: Trident II Tritanium Acetabular Shell
Principal Investigator: John Noble Jr., M.D.
ClinicalTrials.gov Identifier: NCT02999009
The purpose of this study is to review the performance and success rate of an FDA (Food and Drug Administration) approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells. This is a 10 year study.
Imperial Health Center for Orthopaedics is 1 of 8 sites participating in this study across the country. We are the only participating site in Louisiana. The first patient enrolled at Center for Orthopaedics was in September 2018. Enrollment remains open at this site.
