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Rheumatology Practice Management February 2016 Vol 4 No 1 - Clinical Trials Tracker

The following trials represent a selection of key clinical trials that are currently recruiting patients with rheumatic diseases for inclusion in investigations of new therapies or new combinations of available therapies. Each trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov.

1 The Basis and Effects of Rheumatic Health Disparities in Minority Communities

Investigators in this observational study are seeking to explore the causes of rheumatic diseases, and reasons for why many of them affect certain minority communities more severely than others. Patients aged ≥18 years with known or suspected rheumatic disease and who are willing and able to provide informed consent are eligible to enroll. Eligible patients will receive standard medical care for rheumatic disease and arthritis, and—depending on what is needed to assess diagnosis, disease activity, and disease complications—have history and physical examinations and routine laboratory studies obtained. Patients will also be monitored for treatment-related responses and toxicities.

The primary outcome measure is to create hypotheses associated with the basis and/or effects of health disparities in the community; these hypotheses may serve as the basis for future community-based research efforts. This study expects to enroll 100,000 patients at the National Institutes of Health Clinical Center in Bethesda, MD.

For more information contact Michael M. Ward, MD, at 301-496-7263 and wardm1@mail.nih.gov, or the Patient Recruitment and Public Liaison Office at 800-411-1222 (extension TTY8664111010) and prpl@mail.cc.nih.gov. The NLM Identifier is NCT00024479.

2 Blood Components from Healthy Volunteers, Patients with Rheumatic Diseases

The purpose of this observational trial is to collect white blood cells and/or plasma for use in studies comparing the quantity and function of similar cells in healthy volunteers and patients with rheumatic diseases. Patients aged ≥18 years with rheumatic diseases who are not pregnant, do not have a history of bleeding diatheses, and whose hemoglobin is ≥9.0 g/dL may be eligible for enrollment if other criteria are met. Healthy volunteers aged ≥18 years whose hemoglobin is ≥12.0 g/dL, and in whom there is no history of autoimmune or chronic rheumatic disease within the past 5 years (except for osteoarthritis) may be eligible for enrollment if other criteria are met. Eligible participants will have lymphocytes, monocytes, or plasma collected from their blood via apheresis.

The primary outcome measures are the use of peripheral blood mononuclear and mononuclear cells in studies over a time frame of 1 year. This study plans to enroll 100,000 participants at the National Institutes of Health Clinical Center in Bethesda, MD.

For more information contact Sarfaraz A. Hasni, MD, at 301-451-1599 and hasnisa@mail.nih.gov, or the Patient Recruitment and Public Liaison Office at 800-411-1222 (extension TTY8664111010) and prpl@mail.cc.nih.gov. The NLM Identifier is NCT00031174.

3 Twins or Sibling Pairs in Which Only One Person Has a Rheumatic Disorder

Researchers in this observational study are seeking to examine families in which, of 2 siblings or a pair of twins of the same sex, only 1 has developed a systemic rheumatic disease, and assess whether and how they differ in blood cell metabolism, the types of cells they have in their blood, and environmental exposures/genetic factors that might explain the health disparity. Children and adults who are eligible probands with a diagnosis of a systemic rheumatic disorder, together with their twin or sibling of the same sex (who does not have a recognized systemic rheumatic disorder or other autoimmune disease), may be eligible for enrollment if other criteria are met. Siblings do not need to be twins, but must have an age difference ≤5 years. Eligible patients will complete relevant questionnaires and donate blood and urine samples.

The primary outcome measures are the results of the Physician Global Assessment Questionnaire, which will be issued at the time of enrollment. This study expects to enroll 1550 participants at the National Institutes of Health Clinical Center in Bethesda, MD.

For more information contact Frederick W. Miller, MD, at 301-451-6273 and millerf@mail.nih.gov, or the Patient Recruitment and Public Liaison Office at 800-411-1222 (extension TTY8664111010) and prpl@mail.cc.nih.gov. The NLM Identifier is NCT00055055.

4 CARRA Registry Study of Patients with Pediatric Rheumatic Diseases

Investigators in this observational cohort study are seeking to continue the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry by collecting data from children, adolescents, and young adults with pediatric-onset rheumatic diseases. The CARRA Registry will be the foundation of future studies evaluating the safety and clinical outcomes associated with use of therapeutic agents in these patients. Patients aged 2 to 21 years with onset of rheumatic disease prior to age 19 years (age 16 years for juvenile idiopathic arthritis) may be eligible for enrollment if other criteria are met.

The primary outcome measures are to collect essential data elements from children, adolescents, and young adults with pediatric rheumatic diseases, and to evaluate the safety of therapeutic agents in these patient populations, over the course of approximately 10 years. Secondary outcome measures are clinical outcomes, drug treatment patterns and clinical courses, and evaluation of factors other than drug treatment that are associated with clinical outcomes. This study plans to enroll 10,000 participants at multiple locations across the United States and abroad.

For more information contact Laura Schanberg, MD, at 919-684-6601 and laura.schanberg@duke.edu, or Yukiko Kimura, MD, at 551-996-5306 and ykimura@hackensackumc.org. The NLM Identifier is NCT02418442.

5 PF-06438179 and Infliximab in Combination in Patients with Active RA

The purpose of this randomized, parallel-assignment, double-blind, phase 3 trial is to assess the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in patients with active rheumatoid arthritis (RA) who have had inadequate responses to methotrexate. Patients aged ≥18 years who have had a diagnosis of RA based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism criteria for ≥4 months, and who have been receiving methotrexate for ≥12 weeks (including a stable dose for ≥4 weeks) may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive intravenous PF-06438179 or infliximab.

The primary outcome measure is the number of patients with an ACR response ≥20%. Secondary outcome measures include the number of participants who achieve an ACR response ≥50% and ≥70%. Serum drug concentrations and changes from baseline in individual components of ACR response will also be measured. This study expects to enroll 614 patients at multiple locations across the United States and abroad.

For more information contact the Pfizer ClinicalTrials.gov Call Center at 800-718-1021. The NLM Identifier is NCT02222493.

6 Efficacy and Safety of REGN475 in Patients with Osteoarthritis-Induced Pain

Investigators in this randomized, parallel-assignment, double-blind, phase 2/3 trial are seeking to evaluate the effectiveness of REGN475 in patients with knee or hip osteoarthritis (OA)-induced pain, who have a history of inadequate joint pain relief or are intolerant to current analgesic therapy, versus placebo. Patients aged 40 to 80 years with a body mass index of ≤39, moderate-to-severe pain in the index joint, and who have a clinical diagnosis of OA of the knee or hip may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive REGN475 or placebo.

The primary outcome measure is a change in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale scores from baseline to week 16. Secondary outcome measures are changes in the WOMAC physical function subscale score and Patient Global Assessment score from baseline to week 16, incidences of antiREGN475 antibody development, and the occurrence of treatment-emergent adverse events. This study plans to enroll 375 patients at multiple locations across the United States, including Texas, Ohio, and Arizona.

For more information contact the Clinical Trials Administrator at clinicaltrials@regeneron.com. The NLM Identifier is NCT02447276.

7 Diagnostic Genicular Nerve Blocks Following Radiofrequency Ablation

The purpose of this randomized, parallel-assignment, single-blind study is to evaluate whether patients with chronic painful knee osteoarthritis (OA) experience long-term and meaningful improvements in pain, function, and analgesic use, as well as prevention of total knee arthroplasty following radiofrequency ablation (RFA) of the genicular nerves. Patients aged 30 to 80 years with chronic painful knee OA who have had knee pain for ≥6 months, and whose pain is resistant to conventional therapy (eg, opioids, muscle relaxants, physical therapy, nonsteroidal anti-inflammatory drugs) may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to undergo genicular nerve RFA with or without diagnostic genicular nerve blocks, lidocaine, and sensory denervation of the knee joint.

The primary outcome measure is >50% decrease in pain from before to after RFA of the genicular nerves, measured between those who did and did not receive a set of diagnostic blocks. The secondary outcome measure is the mean reduction of the use of morphine equivalent for knee pain from before versus after RFA of the genicular nerves. This study expects to enroll 60 patients at Northwestern University in Chicago, IL.

For more information contact Zachary McCormick, MD, or David Walega, MD, at 312-695-2500. The NLM Identifier is NCT02578108.

8 Efficacy and Safety of TNX-102 SL Tablets in Patients with Fibromyalgia

Researchers in this phase 3, randomized, parallel-assignment, double-blind study are seeking to evaluate the safety and efficacy of TNX-102 SL 2.8-mg tablets in the treatment of patients with fibromyalgia. Patients aged 18 to 75 years with a diagnosis of fibromyalgia who do not have a known hypersensitivity to cyclobenzaprine, a body mass index >40, or severe, untreated sleep apnea may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive placebo or TNX-102 SL 2.8-mg tablets, taken once daily at bedtime for 12 weeks.

The primary outcome measure is average perceived pain, defined as the proportion of patients who improve ≥30% over a time frame of 12 weeks. Secondary outcome measures include a change in results of the Fibromyalgia Impact Questionnaire from baseline to week 12, the incidence of adverse events, and changes in patients’ vital signs. This study plans to enroll 500 patients at multiple locations across the United States.

For more information contact Jennifer Underwood at 267-536-3560 and jennifer.underwood@premier-research.com. The NLM Identifier is NCT02436096.

9 Safety and Tolerability of AMP-110 in Patients with RA

The purpose of this phase 1b, randomized, crossover-assignment, double-blind study is to evaluate the safety, pharmacokinetics, and tolerability of AMP-110 in patients with rheumatoid arthritis (RA). Patients aged 18 to 75 years with a diagnosis of RA per the 1987 revised American College of Rheumatology criteria, a body mass index of 18.5 kg/m2 to 35.0 kg/m2, and who do not have evidence of active or recent infection may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive AMP-110 or placebo once weekly.

The primary outcome measures are the safety and tolerability of repeat doses of AMP-110, measured by the number of adverse events per patient, and repeat dose pharmacokinetic parameters of AMP-110 in serum. The secondary outcome measure is the optimal dose for repeat dosing of AMP-110. This study expects to enroll 27 patients at locations in Alabama, Texas, Florida, Pennsylvania, Maryland, and Nebraska.

For more information contact Danielle Cortese at 407-271-8030 and dcortese@omegarcllc.com, Rachel Dossman at 214-879-6737, ext. 200, and rdossman@mcrcdallas.com, or Tracey Madonna at 814-693-0300 and traceymadonna@altoonaresearch.com. The NLM Identifier is NCT02277574.

10 CFZ533 in Healthy People versus Patients with Rheumatoid Arthritis

Investigators of this phase 1, randomized, parallel-assignment, double-blind study are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of using intravenous doses of CFZ533 in patients with rheumatoid arthritis (RA), and single intravenous and subcutaneous doses of CFZ533 in healthy individuals. For the healthy cohort, people aged 18 to 55 years who have vital signs within the normal limits, a weight of 50 kg to 150 kg, and a body mass index of 18 kg/m2 to 32 kg/m2 may be eligible for enrollment if other criteria are met. For the cohort with RA, patients aged 18 to 55 years who have RA per the 2010 American College of Rheumatology/European League Against Rheumatism criteria may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive a single dose of CFZ533 at varying dosage levels (depending on treatment assignment) or placebo.

The primary outcome measures are safety and tolerability, defined by the number of patients with adverse events. Secondary outcome measures include the plasma pharmacokinetics and immunogenicity of CFZ533. This study plans to enroll 80 patients at locations in Florida, Pennsylvania, Alabama, and Nebraska.

For more information contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT02089087.

11 Applying Transcutaneous Electrical Nerve Stimulation in Patients with Fibromyalgia

The purpose of this phase 2, randomized, double-blind, factorial-assignment study is to examine the efficacy of transcutaneous electrical nerve stimulation (TENS) in patients with fibromyalgia. The investigators hypothesize that applying TENS will improve quality of life in this patient population by reducing resting- and movement-related pain and central excitability by restoring diffuse noxious inhibitory controls, in turn decreasing fatigue and fear of movement. Women aged 18 to 70 years who have a diagnosis of fibromyalgia per the 1990 American College of Rheumatology criteria, history of cervical or lumbar pain, and who do not have uncontrolled blood pressure or diabetes may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive standard care (ie, no TENS), placebo TENS, and active TENS.

The primary outcome measure is the effect of long-term TENS use on movement-related pain; this will be calculated using a numeric rating scale during a 6-minute walk test. Secondary outcome measures include function and quality of life, pressure pain threshold, and conditioned pain modulation. This study expects to enroll 360 patients at locations in Iowa City, IA, and Nashville, TN.

For more information contact Kathleen A. Sluka, PT, PhD, at slukalab@uiowa.edu, Dana L. Dailey, PT, PhD, at 319-335-7149, or Leslie Crofford, MD, at 615-322-4746 and leslie.j.crofford@vanderbilt.edu. The NLM Identifier is NCT01888640.

12 Abatacept plus Methotrexate versus Methotrexate Alone in Adults with Early RA

Researchers in this phase 3, randomized, parallel-assignment, double-blind study are seeking to determine whether abatacept is effective for treating patients with early rheumatoid arthritis (RA). Patients aged ≥18 years who have had a diagnosis of RA for <6 months, with ≥3 swollen and 3 tender joints, and who do not have acute infection may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive abatacept plus methotrexate, methotrexate alone, or an abatacept or methotrexate placebo.

The primary outcome measure is the proportion of patients in Simple Disease Activity Index remission over a time frame of 24 weeks. Secondary outcome measures include the number of patients in Disease Activity Index C-reactive protein remission, the number of patients in Boolean remission, as well as the mean change in joint damage radiographic progression from baseline to 52 weeks. This study plans to enroll 1000 patients at multiple locations across the United States and abroad.

For more information contact clinical.trials@bms.com. The NLM Identifier is NCT02504268.

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Last modified: March 11, 2016
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