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Rheumatology Practice Management April 2017 Vol 5 No 2 - Clinical Trials Tracker

The following clinical trials represent a selection of key studies that are currently recruiting patients with osteoarthritis for inclusion in investigations of new therapies and new regimens of existing treatments for individuals with the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1. Safety of Intra-Articular ScrAAV2.5IL-1Ra for Moderate Knee Osteoarthritis

The objective of this nonrandomized, open-label, parallel-assignment, phase 1 clinical trial is to evaluate the safety of 3 unique doses of intra-articular scrAAV2.5IL-1Ra in patients with moderate osteoarthritis of the knee. Patients aged 18 to 65 years with moderate osteoarthritis of the knee who have persisting symptoms despite using standard nonsteroidal anti-inflammatory drugs may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive low, medium, or high doses of intra-articular scrAAV2.5IL-1Ra.

The primary outcome measure is the number of patients who have adverse events, measured over the course of 53 weeks. This study plans to enroll 9 patients at the Mayo Clinic, Rochester, MN. For more information, contact Tyson L. Scrabeck at 507-538-1016 or scrabeck.tyson@mayo.edu, or Zachary W. Pohlkamp at 507-293-7466 or pohlkamp.zachary@mayo.edu. The NLM Identifier is NCT02790723.

2. Safety, Efficacy, and Tolerability of Steroid Delivery System for Pain Relief

This single-group, open-label, phase 1 clinical trial will assess the safety, efficacy, and tolerability of using a longer-duration, controlled, sustained-release dexamethasone delivery system in patients with osteoarthritis to reduce pain, maintain functionality, and delay the need for knee replacement. Patients aged 40 to 99 years with diagnosed unilateral or bilateral knee osteoarthritis in accordance with the American College of Rheumatology (ACR) Criteria for Classification of Idiopathic Osteoarthritis of the Knee ≥6 months before screening and a body mass index ≤40 kg/m2 may be eligible for enrollment if other criteria are met. Eligible patients will receive dexamethasone via a sustained delivery system.

The primary outcome measures are treatment-related adverse events and changes in the weekly mean of the pain intensity score from baseline to weeks 12 and 24. Secondary outcome measures include time of pain relief onset, average weekly use of rescue medications, and average total consumption of rescue medications. This study expects to enroll 6 patients at the Hospital for Special Surgery, New York, NY. For more information, contact Ryan Sutherland at 646-797-8473 or sutherlandry@hss.edu. The NLM Identifier is NCT02873273.

3. Efficacy of Allograft Tissue Injection in Patients with Moderate Hip Arthritis

The objective of this single-group, nonrandomized clinical trial is to evaluate the efficacy of the ReNu injection, an allograft tissue comprising particularized amniotic membrane and amniotic fluid cells, in patients with moderate osteoarthritis of the hip. Patients aged 18 to 70 years with moderate hip osteoarthritis who have a body mass index <40 kg/m2 may be eligible for enrollment if other criteria are met. Eligible patients will be given a single ReNu injection.

The primary outcome measures are changes from baseline in the International Hip Outcome Tool 12 and Visual Analog Scale. Secondary outcomes measures are changes from baseline in the Modified Harris Hip Score, Short Form (SF)-12 score, and Single Assessment Numeric Evaluation. This study plans to enroll 10 patients at Stanford Medicine Orthopaedic Surgery, Redwood City, CA, and Rush University Medical Center, Chicago, IL. For more information, contact Marc R. Safran, MD, at 650-721-7618 or msafran@stanford.edu, or Elizabeth A. Handley, MS, at 650-721-7614 or ehandley@stanford.edu. The NLM Identifier is NCT03063099.

4. Pulsed Radiofrequency Compared with Physical Therapy for Chronic Knee Osteoarthritis

This randomized, parallel-assignment, open-label clinical trial will assess the effectiveness of using pulsed radiofrequency compared with physical therapy for the treatment of patients with chronic osteoarthritic knee pain. Patients aged ≥18 years with radiologic evidence of grade 1 to 3 Kellgren-Lawrence knee arthritis and who meet ACR criteria for a knee osteoarthritis diagnosis may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive pulsed radiofrequency or physical therapy.

The primary outcome measure is pain scores in the Visual Analog Scale for Pain, measured at baseline, 1 month, and 3 months. The secondary outcome measure is the safety of using pulsed radiofrequency for the treatment of knee pain, determined by any adverse events that occur in the study group. This study expects to enroll 50 patients at the Long Beach Veterans Hospital, CA. For more information, contact Ronald Takemoto, MD, at 562-826-5554. The NLM Identifier is NCT02294864.

5. Safety and Analgesic Efficacy of V120083 for Knee Osteoarthritis

The objective of this multicenter, randomized, double-blind, placebo- and active-controlled, phase 2a clinical trial is to evaluate the safety and analgesic efficacy of using V120083 twice daily for the treatment of patients with moderate-to-severe chronic pain caused by knee osteoarthritis compared with placebo. Patients aged 40 to 80 years with moderate-to-severe chronic osteoarthritis knee pain that lasts several hours daily and who meet ACR diagnostic criteria for their knee osteoarthritis pain may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive V120083 30 mg and 60 mg plus placebo, naproxen 500 mg plus placebo, or just placebo.

The primary outcome measure is the daily level of average pain in the past 24 hours, over a time frame of 4 weeks. Secondary outcomes include scores from various Western Ontario and McMaster Universities Osteoarthritis Indexes, Modified Brief Pain Inventory-SF subscales, Medical Outcomes Study SF-36 subscales, and Patient Global Impression of Change scale. This study plans to enroll 276 patients at the Diagnostics Research Group, San Antonio, TX. For more information, contact the Trial Information Center at 877-292-2015 or PurdueVAN2001.CCO@quintiles.com. The NLM Identifier is NCT03028870.

6. Comparing the Efficacy of Adductor Canal Blocks with Periarticular Bupivacaine Injections

This randomized, parallel-assignment, phase 4 clinical trial will assess the efficacy of using adductor canal blocks for the management of pain in patients with total knee arthroplasty as it compares with that of periarticular bupivacaine injections. Patients of all ages who are undergoing unilateral primary total knee arthroplasty and receiving care from the 2 senior arthroplasty surgeons at Columbia University Medical Center, New York, NY, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive adductor canal blocks or periarticular bupivacaine injections.

The primary outcome measure is changes in pain scores according to the Visual Analog Scale. The secondary outcome measures are length of hospital stay, changes in activity level and range of knee flexion, and opioid consumption. The percentage of patients disposed to their home or to home-based health services will also be measured. This study expects to enroll 250 patients at Columbia University Medical Center. For more information, contact Taylor Murtaugh, BS, at 212-305-8193 or tm2750@cumc.columbia.edu, or Matthew Grosso, MD, 516-662-8708 or mjg2235@cumc.columbia.edu. The NLM Identifier is NCT02777749.

7. Safety and Analgesic Efficacy of Low-Dose Naltrexone

The objective of this randomized, double-blind, phase 2 clinical trial is to evaluate the use of low-dose naltrexone for the treatment of chronic pain in patients with osteoarthritis and inflammatory arthritis. Patients aged ≥18 years who have osteoarthritis, rheumatoid arthritis, and/or nonaxial spondylo­arthritis who are registered to receive medical care through the VA Boston Healthcare System may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive naltrexone for 8 weeks followed by placebo for 8 weeks, or vice versa, in a blinded crossover fashion.

The primary outcome measure is the Brief Pain Inventory on pain interference. Secondary outcomes include scores from the Brief Fatigue Inventory, pressure pain threshold testing, and Clinical Global Impression—Severity. This study plans to enroll 60 patients at the VA Boston Healthcare System Jamaica Plain Campus, MA. For more information, contact Paul A. Monach, MD, PhD, at 857-364-6662 or Paul.Monach@va.gov, or Maureen Dubreuil, MD, at 857-364-5552 or maureen.dubreuil@va.gov. The NLM Identifier is NCT03008590.

8. Assessing the Efficacy of the TITAN Reverse Shoulder System

This postmarket, follow-up clinical trial will evaluate the short-, mid-, and long-term outcomes associated with the use of the TITAN Reverse Shoulder System, a semiconstrained total shoulder construct, during initial or revision total shoulder arthroplasty. Patients aged ≥21 years who have—or received unsuccessful joint replacement for—grossly lacking rotator cuff with severe arthropathy, and who have a shoulder joint that is anatomically and structurally appropriate for use with the TITAN device may be eligible for enrollment if other criteria are met. All eligible patients will receive an operation with the TITAN Reverse Shoulder System.

The primary outcome measures are survival, defined as a lack of implant component removal or revision, and the absence of any unan­ticipated, device-related, serious adverse events. The secondary outcome measure is efficacy, determined via the comparison of postsurgery clinical results measured with the American Shoulder and Elbow Surgeons Score, EQ-5D score, range of motion, constant score, Visual Analog Scale for Pain, and radiographs. This study expects to enroll 150 patients at the Rothman Institute, Philadelphia, PA. For more information, contact Andrew Tummon at 609-936-5490 or andrew.tummon@integralife.com. The NLM Identifier is NCT02204228.

9. Intra-Articular Corticosteroid versus Intra-Articular Ketorolac

The objective of this randomized, double-blind, phase 4 clinical trial is to evaluate the efficacy of intra-articular betamethasone injection with intra-articular ketorolac injection in patients with knee osteoarthritis. Patients aged ≥18 years who have osteoarthritis of the knee determined as being Kellgren-Lawrence grade ≥2 via x-ray may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive intra-articular betamethasone or intra-articular ketorolac.

The primary outcome measure is the Western Ontario and McMaster Universities Osteoarthritis Index. Secondary outcomes measures include the Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score, and the Knee Outcome Survey Activities of Daily Living Scale. This study plans to enroll 448 patients at St. Luke’s University Health Network, Bethlehem, PA. For more information, contact Manny Changalis, MS, CIP, at 484-526-4944 or manny.changalis@sluhn.org, or Paul Morton, MD, at 808-253-8696 or mortonp@slhn.org. The NLM Identifier is NCT02612272.

10. Safety, Practicality of Autologous Adipose-Derived Mesenchymal Stromal Cells

This nonrandomized, open-label, parallel-assignment, phase 1 clinical trial will assess the safety and practicality of using adipose-derived mesenchymal stromal cells for the treatment of patients with mild-to-severe osteoarthritis of the knee. Patients aged 40 to 70 years who have had unilaterally symptomatic, primary femorotibial osteoarthritis of the knee for >3 months and who can routinely walk without assistance may be eligible for enrollment if other criteria are met. All eligible patients will receive injections of autologous adipose-derived mesenchymal stromal cells.

The primary outcome measure is the proportion of patients who have adverse events, determined over the course of 2 years following the final trial injection. This study expects to enroll 24 patients at the Mayo Clinic, Rochester, MN. For more information, contact Tyson L. Scrabeck at 507-538-1016 or scrabeck.tyson@mayo.edu, or Zachary W. Pohlkamp at 507-293-7466 or pohlkamp.zachary@mayo.edu. The NLM Identifier is NCT02805855.

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Last modified: May 5, 2017
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