Clinical Trials Offered

Below is a list of our currently enrolling studies at Metroplex Clinical Research Center as well as upcoming studies.  If you have any questions, please do not hesitate to give us a call at (214) 879-6737 or contact us using the CONTACT US form.

 
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IndicationsTrial IDTrial StatusTrial NameTrial TitleTrial CommentsClinicalTrials.gov ID
Anklyosing SpondylitisNovartis ASLeapEnrollingStudy estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitisStudy estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis

http://www.novartisclinicaltrials.com

NCT03350815
Anklyosing SpondylitisPfizer A3921120EnrollingA Phase 3, Randomized, Double-blind, Placebo-controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double-blind, Placebo-controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) NCT03502616
Giant Cell ArteritisSanofi 068UpcomingA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell ArteritisA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis NCT03600805
LupusGilead 4092EnrollingA Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE) NCT03134222
LupusGilead 4093EnrollingA Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN)A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN) NCT03285711
LupusLilly I4V-MC-JAIAUpcomingA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus NCT03616964
LupusNektar 358EnrollingNKTR-358 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance.This study will evaluate the safety, tolerability, PK, and immunologic effects of multiple doses of NKTR-358 in patients with minimal to moderate SLE. The effects on SLE disease activity will also be evaluated. SLE patients will be randomized to receive multiple SC doses of NKTR-358 or receive placebo. After receiving the last dose of NKTR-358 or placebo, patients will be followed for an additional 50 days to evaluate safety, PK, PD, and preliminary efficacy. NCT03556007
LupusResolve 132EnrollingA Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) NCT02660944
Osteoarthritis of the KneeCentrexion 301EnrollingA Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee PainA Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain NCT03429049
Osteoarthritis of the KneeCentrexion 303UpcomingThis is an open-label, single injection (per knee), 8-week study to evaluate the comfort and ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a single intra-articular (IA) injection, in one or both knees, of 1.0 mg of CNTX-4975-05 in subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the investigational product, CNTX-4975-05, will be controlled primarily through adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine.This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a single intra-articular (IA) injection, in one or both knees, of 1.0 mg of CNTX-4975-05 in subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the investigational product, CNTX-4975-05, will be controlled primarily through adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine. NCT03661996
Osteoarthritis of the KneeUnity UBX0101EnrollingThis study is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study that will evaluate safety, tolerability, and pharmacokinetics of UBX0101 in patients diagnosed with painful femoro-tibial osteoarthritis.This study is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study that will evaluate safety, tolerability, and pharmacokinetics of UBX0101 in patients diagnosed with painful femoro-tibial osteoarthritis. Patients will be randomly allocated to receive UBX0101 or placebo in 3:1 randomization by dose level (cohort). The primary objective is to establish the safety and tolerability of UBX0101 given as a single intra-articular injection into the femoro-tibial joint of patients with osteoarthritis. NCT03513016
Osteoarthritis of the Knee, Osteoarthritis of the HipRegeneron 1523UpcomingA Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or HipA Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip NCT02683239
Osteoarthritis of the Knee, Osteoarthritis of the HipRegeneron 1602UpcomingA Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group, Multi-Dose Study in Patients With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee or Hip to Assess the Patients' Ability to Self-Administer Fasinumab in an Unsupervised Setting, Using Either an Auto-Injector or a Prefilled SyringeA Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group, Multi-Dose Study in Patients With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee or Hip to Assess the Patients' Ability to Self-Administer Fasinumab in an Unsupervised Setting, Using Either an Auto-Injector or a Prefilled Syringe NCT03491904
Polymyalgia RheumaticaSanofi 160UpcomingA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia RheumaticaA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica NCT03600818
PsoriasisBMS IM011046UpcomingA Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque PsoriasisA Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis NCT03624127
Psoriatic ArthritisAbbVie M14-496EnrollingA Phase 4 open-label randomized controlled study COmparing the effectiveness of adalimumab iNTROduction and methotrexate dose escaLation in subjects with Psoriatic Arthritis (CONTROL)A Phase 4 open-label randomized controlled study COmparing the effectiveness of adalimumab iNTROduction and methotrexate dose escaLation in subjects with Psoriatic Arthritis (CONTROL)

For more information contact recruiting 214-424-0405

NCT02814175
Psoriatic ArthritisAbbVie M15-554EnrollingThis is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1. NCT03104374
Psoriatic ArthritisAbbVie M15-572EnrollingA Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1

For More information please call 214-424-0405 or email us at info2@mcrcdallas.com

NCT03104400
Rheumatoid ArthritisAmgen 20150196EnrollingA Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid ArthritisA Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis

For more information please contact Recruitment 214.424.0405

NCT03156023
Rheumatoid ArthritisAmgen 592149EnrollingPhase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA. Phase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA. Phase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA. NCT03410056
Rheumatoid ArthritisTarget RAEnrollingIn a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening)In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening) NCT02374021
Rheumatoid Arthritis, LupusPfizer C1001EnrollingA Phase 1, Randomized, Multi-center, Double-blind, Sponsor Open, Placebo-controlled, Single And Multiple Dose-escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid ArthritisA Phase 1, Randomized, Multi-center, Double-blind, Sponsor Open, Placebo-controlled, Single And Multiple Dose-escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis NCT03334851
SclerodermaCorbus JBT101-SSc-002EnrollingA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis NCT03398837