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Rheumatology Practice Management April 2016 Vol 4 No 2 - Clinical Trials Tracker

The following clinical trials represent a selection of key clinical trials that are currently recruiting patients with ankylosis for inclusion in investigations of new therapies and new regimens of available therapies for patients with ankylosing rheumatic diseases. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Maintenance of Sustained Remission in Patients with Spondyloarthritis

The purpose of this multicenter, open-label study—which is followed by a phase 3, double-blind, randomized study—is to compare the maintenance of sustained remission in patients with axial spondyloarthritis (axSpA) who are receiving certoliz­umab pegol (CZP) versus placebo. Men and women aged 18 to 45 years may be eligible for study inclusion if they have a documented diagnosis of active, adult-onset axSpA with symptoms lasting ≥3 months, in addition to meeting other enrollment criteria.

Eligible patients will receive CZP 200 mg subcutaneously every 2 weeks, 200 mg subcutaneously every 4 weeks, or placebo. The primary outcome of the study is the percentage of patients who don’t experience a flare from weeks 48 to 96. Secondary outcome measures include the percentage of patients who achieve sustained remission at 48 weeks, and fall into categories in part A of the Ankylosing Spondylitis Disease Activity Score index.

The study plans to enroll 750 patients at multiple locations across the United States. For more information, contact the UCB Clinical Trial Call Center at 877-822-9493. The NLM Identifier is NCT02505542.

2 Evaluation of Etanercept Withdrawal, Retreatment in Patients with Spondyloarthritis

Investigators in this multicenter, open-label study are seeking to evaluate the risks and benefits of etanercept withdrawal in patients with nonradiographic axial spondyloarthritis (axSpA) who have achieved a significant clinical response. Men and women aged 18 to 49 years who have a diagnosis of axSpA with symptoms >3 months, and back pain for <5 years, with a less than favorable response to nonsteroidal anti-inflammatory drugs, may be eligible for enrollment if other criteria are met.

Patients will receive etanercept 50 mg subcutaneously once a week for 24 weeks. The primary outcome of the study is to estimate the proportion of patients who have flares at any time ≤40 weeks following withdrawal of etanercept. Secondary outcomes include measurement of the time to flare following withdrawal of etanercept, and occurrence of Ankylosing Spondylitis Disease Activity Score C-reactive protein <1.3.

This study expects to enroll 200 patients at multiple locations across the United States and abroad. For more information, contact the Pfizer CT.gov Call Center at 800-718-1021. The NLM Identifier is NCT02509026.

3 Examining Bacteria, Changes in Colon Tissue in Patients with SpA

As part of this cross-sectional, observational, case-control study, the investigators aim to assess the relationship between systemic autoimmune disease and changes in colon tissue among patients with inflammatory bowel disease (IBD) and ankylosing spondyloarthritis (SpA). Men and women aged 18 to 70 years may be eligible for study inclusion if enrollment criteria are met, including diagnosis of axial SpA by a rheumatologist that meets the Assessment of SpondyloArthritis International Society axial SpA criteria.

Eligible patients with ankylosing spondylitis will undergo routine colonoscopies or flexible sigmoidoscopies, as well as fill out questionnaires, give blood, undergo rectal swabs, and have pinch biopsies taken during endoscopies. Healthy controls and patients with IBD will undergo slightly different procedures compared with patients with SpA. The primary outcome of interest is comparing intraepithelial lymphocyte (IEL) characteristics in patients with IBD and ankylosing SpA to those of healthy controls at 2 years. Secondary outcomes include microbiome differences in healthy controls, and patients with IBD and ankylosing SpA, as well as microbiome changes reflected in IELs.

This study plans to enroll 60 patients in Denver, CO. For more information, contact Neha Ohri, MD, at 303-724-8258 and neha.ohri@ucdenver.edu. The NLM Identifier is NCT02389075.

4 Safety and Efficacy of Nexel in Patients with Total Elbow Replacement

Researchers in this open-label, retrospective and prospective outcomes study are evaluating the safety and efficacy of Zimmer Inc’s Nexel Total Elbow among patients with primary or revision total elbow replacement. Men and women aged ≥18 years who are candidates for primary or revision total elbow arthroplasty, and willing and able to complete scheduled follow-up evaluations may be eligible for inclusion if other criteria are met.

The retrospective part of the study will include patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and have surgical details available, whereas the prospective portion of the study will include patients who are having primary or revision total elbow arthroplasty, and will receive the Nexel Total Elbow. The primary outcome of the study is survivorship over a time frame of 10 years.

This study plans on enrolling approximately 120 patients at the OrthoCarolina Research Institute, Charlotte, NC, and Rothman Institute, Philadelphia, PA. For more information, contact Jarrod Hunnicutt, BS, CCRA, at 574-371-9785 and jarrod.hunnicutt@zimmerbiomet.com. The NLM Identifier is NCT02469662.

5 Fusion, Joint Relief Evaluation of SImmetry Sacroiliac Joint Fusion System

Investigators in this prospective, observational cohort study aim to evaluate fusion and joint relief with the SImmetry Sacroiliac Joint Fusion System among patients with sacroil­iac joint dysfunction. Criteria for study inclusion include being aged ≥18 years, men or women, and indicated for the SImmetry device according to the approved SImmetry labeling; participants must also have 2 positive provocative tests for sacroiliac joint pain.

The primary outcome of the study is sacroiliac joint fusion at 24 months, and sacroiliac joint pain reduction at 6 months. Secondary outcomes include sacroiliac joint pain reduction at 24 months.

The investigators of this study plan to enroll 25 patients at the Reno Orthopaedic Clinic, Reno, NV. For more information, contact Megan O’Toole at 952-698-9944 and motoole@zyga.com. The NLM Identifier is NCT02560714.

6 Real-Life Persistence of Inflectra in Patients with Rheumatologic Conditions

As part of this prospective, observational cohort, investigators are evaluating the persistence of Inflectra (infliximab) in patients with rheumatologic disease—including ankylosing spondylitis—who are biologics-naive to, or switching over from, stable Remicade to Inflectra. Men or women may be eligible for study inclusion if they are aged ≥18 years, prescribed Inflectra or Remicade for their conditions, and meet other enrollment criteria.

The primary outcome measures include time to discontinuation from study drug in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, as well as the reason for study discontinuation, evaluated approximately every 2 months, for a total follow-up of 2 years. Secondary outcomes of measure include assessment of infliximab effectiveness in patients with rheumatoid arthritis, psoriatic arthritis, or psoriatic arthritis based on the Disease Activity Score 28.

The investigators plan on enrolling 1500 patients at multiple locations across Canada. For more information, contact Susan Reid, MEd, PMP, at 224-212-4706 and susan.reid2@hospira.com. The NLM Identifier is NCT02605642.

7 Certolizumab versus Placebo in Patients with Spondyloarthritis

Researchers in this multicenter, randomized, placebo-controlled, double-blind, phase 3 study are seeking to evaluate the safety and efficacy of certolizumab pegol (CZP) in patients with active axial spondyloarthritis without x-ray evidence of ankylosing spondylitis and objective signs of inflammation. Men and women aged ≥18 years who have documented disease as defined by the specified Assessment of Spondylo Arthritis International Society criteria with symptoms lasting ≥12 months prior to screening may be eligible for inclusion if other criteria are met.

Patients in the experimental group will receive subcutaneous CZP 400-mg injections on weeks 0, 2, and 4, followed by subcutaneous CZP 200- mg injections every 2 weeks from week 6 onward. Patients in the control group will receive matching placebo to CZP injections every 2 weeks from week 0 onward. The primary outcome measure is the percentage of subjects meeting the Ankylosing Spondylitis Disease Activity Score major improvement response criteria at 52 weeks. Secondary outcome measures include the percentage of patients with Axial SpondyloArthritis International Society 40% response criteria at weeks 12 and 52.

The study plans to enroll 300 patients at multiple locations across the United States. For more information, contact the UCB Clinical Trial Call Center at 877-822-9493. The NLM Identifier is NCT02552212.

8 Safety and Efficacy of Herpes Zoster Vaccine

In this study, the investigators are evaluating the safety and efficacy of Zostavax, the live herpes zoster vaccine, in patients with rheumatologic conditions (eg, ankylosing spondylitis) who are using anti–tumor necrosis factor (TNF). Men and women may be eligible for inclusion in the study if they are aged ≥50 years, currently being treated with an anti-TNF therapy, and have not previously received the Zostavax vaccine; they must also meet other enrollment criteria.

Patients who are eligible for inclusion will be randomized to either the treatment arm and receive the live herpes zoster vaccine, or to the placebo arm and receive placebo. The primary outcome of interest is immunogenicity, measured at 6 weeks. The secondary outcomes are the clinical effectiveness of the herpes zoster vaccine in reducing longer-term herpes zoster risk 2 years postvaccination, and vaccine safety of all serious adverse events, in addition to nonserious vaccine-strain varicella zoster virus events within 42 days of vaccination.

The investigators plan to enroll approximately 125 patients at the University of Alabama at Birmingham, and Oregon Health & Science University, Portland. For more information, contact Randall Parks, MBA, at 205-934-7727 and rand1951@uab.edu. The NLM Identifier is NCT02538757.

9 Safety, Efficacy, Tolerability of Secukinumab in Patients with Ankylosing Spondylitis

As part of this randomized, double-blind, placebo-controlled phase 3 study, the investigators are evaluating the safety, efficacy, and tolerability of secukinumab with and without a loading regimen in patients with active ankylosing spondylitis. Men and women may be eligible for inclusion if they are aged ≥18 years, have moderate-to-severe ankylosing spondylitis and prior radiographic evidence according to the Modified New York Criteria (1984), as well as inadequate response to nonsteroidal anti-inflammatory drugs, and if other enrollment criteria are met.

Patients will be randomized to receive either subcutaneous secukin­umab 150-mg injections with loading at baseline, weeks 1, 2, and 3, followed by dosing every 4 weeks starting at week 4; subcutaneous secukinumab 150-mg injections without loading at baseline, followed by dosing every 4 weeks starting at week 4, with placebo at weeks 1, 2, and 3; or placebo at baseline, weeks 1, 2, 3, 4, 8, and 12, followed by dosing with secukinumab 150 mg every 4 weeks starting at week 16. The primary measure outcome is Assessment of SpondyloArthritis International Society criteria at 16 weeks. Secondary outcomes of measure include Assessment of Spondylo­Arthritis International Society 40% response at 16 weeks, and serum high-sensitivity C-reactive protein.

The investigators are expecting to enroll 324 patients in multiple locations across the United States. For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT02159053.

10 Evaluating Certolizumab Pegol Placental Transfer in Pregnant Patients

Researchers in this multicenter, postmarketing study are seeking to evaluate the placental transfer of certolizumab pegol (CZP) in pregnant women receiving the drug. Women aged ≥18 years being treated with CZP and who are at ≥30 weeks of gestation with a singleton or twins may be eligible for inclusion if other enrollment criteria are met.

Patients included in the study will provide their own pharmacokinetic samples at day 0 (ie, within 24 hours prior to and after delivery), and samples from their infant within 24 hours of birth, and at weeks 4 and 8, as well as from the umbilical cord ≤1 hours after delivery. The primary outcome measure of the study is plasma concentration of CZP in the participating infants at the time of their birth (day 0). Secondary outcomes of measure include plasma concentration of CZP in the mother at the time of delivery (day 0), and the ratio of plasma concentration of CZP between the infants and their mother at delivery.

Anticipated enrollment of approximately 20 patients is expected at multiple locations across the United States and abroad. For more information, contact the UCB Clinical Trial Call Center at 877-822-9493. The NLM Identifier is NCT02019602.

11 Online Program to Help Patients with Inflammatory Arthritis Remain Employed

Investigators in this randomized controlled trial are evaluating the use of an online program to assist people with inflammatory arthritis, including ankylosing spondylitis, in remaining employed. Men and women aged 18 to 59 years who are able to read and write in English, have access to a computer, and are working may be eligible for inclusion if other enrollment criteria are met.

Study participants in the intervention group will take part in an online e-learning program, an ergonomic assessment by an occupational therapist, as well as a job retention vocational counseling by a vocational rehabilitation counselor, whereas study participants in the control group will receive standard care and printed educational materials about work and arthritis. The primary outcome measures are an efficacy analysis of productivity at work, and cost-effectiveness analysis of at-work productivity 2 years postintervention, as well as efficacy analysis of work cessation over 5 years of follow-up. Secondary outcome measures include temporary work cessation and occasional work absence.

Approximately 526 patients are being recruited for this study at the Arthritis Research Centre in Richmond, British Columbia, Canada. For more information, contact Pamela A. Rogers, MA, at 604-207-4016 and progers@arthritisresearch.ca. The NLM Identifier is NCT01852851.

12 Monitoring Planned, Unplanned Pregnancies in Patients Taking Cimzia

As part of this prospective, observational cohort—the Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project—investigators are seeking to monitor planned and unplanned pregnancies in patients who have autoimmune disorders (eg, ankylosing spondylitis) and are exposed to certolizumab pegol (Cimzia). Women who are currently pregnant and residing in the United States or Canada may be eligible for inclusion in the study.

Patients will be evaluated for potential effects of their disease, and/or exposure to the medication, on their pregnancy outcome, including child development and growth for ≤5 years. The primary outcome measure is major malformation throughout the duration of the pregnancy and at ≤1 years in the infant’s life. Secondary outcome measures include minor malformations, pregnancy outcomes, as well as infant follow-up.

The investigators are planning to enroll approximately 300 patients at the University of California, San Diego. For more information, contact Diana Johnson, MS, at 877-311-8972 and d4johnson@ucsd.edu. The NLM Identifier is NCT01797224.

13 Evaluating the Natural History of Spondyloarthritis

Investigators in this prospective, observational study are seeking to evaluate the natural history and pathogenesis of spondyloarthritis (SpA). Men and women are eligible for study inclusion if they meet enrollment criteria; patients aged <16 years may be considered if they meet International League of Associations for Rheumatology criteria for enthesitis-related arthritis, and patients aged ≥16 years may be considered if they have previously met criteria for enthesitis-related arthritis, or currently meet European Spondyloarthropathy Study Group or Amor criteria for axial SpA, or Modified New York Criteria for ankylosing spondylitis.

As part of the study, patients will be screened with medical records and family histories, as well as undergo a physical examination and medical history. Investigators will also perform imaging studies and other samples may be collected, in addition to possible sampling of skin tissue and bone marrow. The primary outcome of the study is to establish a cohort of pediatric and adult patients with SpA to prospectively evaluate the signs and symptoms, magnetic resonance imaging and x-ray findings, and bone and inflammatory biomarkers linked to axial disease. Secondary outcome measures include the study of pathogenic mechanisms, including the role of ankylosing spondylitis susceptibility genes and their variants in causing disease; patients will also be identified for possible entry into future treatment studies.

The investigators are continuously enrolling patients at the National Institutes of Health Clinical Center, Bethesda, MD. For more information, contact April Brundidge, RN, at 301-443-5407 and brundidgea@mail.nih.gov. The NLM Identifier is NCT01422694.

14 Evaluating Progression of Spinal Fusion with CTs, X-Rays, and MRI

Researchers in this prospective, observational study are evaluating the progression of spinal fusion in patients with ankylosing spondylitis. Men and women aged ≥18 years who are diagnosed with the condition according to the Modified New York Criteria, and who have a lumbar spine Bath Ankylosing Spondylitis Radiology Index score of 0, 1, 2, or 3 may be eligible for inclusion if other enrollment criteria are met.

As part of the study, patients will have 8 clinic visits scheduled at the beginning of the study, and undergo clinical assessments, blood tests, x-rays, computed tomography (CT) scans, and magnetic resonance imaging (MRI), as well as complete a symptoms questionnaire by mail every 4 months for 2 years. The primary outcome measure is syndesmophyte growth at 1 and 2 years. The investigators will also evaluate whether CT scanning is better than regular x-rays for measuring changes in the stiffness or fusion of the spine, and whether CT scans can be used to determine how fast extra bones form in the spine of patients with ankylosing spondylitis.

Approximately 75 patients are expected to be enrolled for this study at Johns Hopkins University, Baltimore, MD, and the National lnstitutes of Health Clinical Center, Bethesda, MD. For more information, contact Michael M. Ward, MD, at 301-496-7263 and wardm1@mail.nih.gov. The NLM Identifier is NCT00085995.

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Last modified: May 20, 2016
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