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Rheumatology Practice Management August 2016 Vol 4 No 4 - Clinical Trials Tracker

The following clinical trials represent a selection of key clinical trials that are currently recruiting patients with juvenile idiopathic arthritis (JIA) for inclusion in investigations of new therapies and new regimens of available therapies for patients with JIA. Each 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 trials.

1 Evaluating the Efficacy of Internet-Based Self-Education

In this randomized, single-blind study, investigators seek to evaluate the effectiveness of an online intervention program versus a static education program in improving pain and health-related quality of life, as well as anxiety, depression, and treatment adherence, among patients with JIA. Both sexes are eligible to enroll in this study; other criteria for enrollment include being aged 12 to 18 years, having diagnoses of JIA per the International League of Associations for Rheumatology (ILAR) classification criteria and parents and/or primary care providers who are able to speak and read English or French, and being willing and able to complete online measures. Patients eligible for study inclusion will be randomized to 1 of 2 study arms. The experimental group will receive “Taking Charge: Managing JIA Online,” an Internet-based self-management program, in addition to standard care, whereas the control group will be provided access to the JIA resource center, along with standard care.

The primary outcome measures include pain and quality of life. This study plans to enroll 294 patients across Canada. For more information, contact Jennifer N. Stinson, RN, PhD, CPNP, at 416-813-7654 (ext. 4514) or jennifer.stinson@sickkids.ca. The NLM Identifier is NCT01572896.

2 Patient-Centered Adaptive Treatment Strategies

As part of this observational, cohort prospective study, investigators are developing a method to analyze data in situations where disease and treatment may change over time. Based on these data, they may be able to create an Internet-based program for providers to use when making treatment decisions in patients with JIA.

Patients may be eligible for enrollment if they are aged 2 to 19 years, diagnosed with JIA, and have a study visit documented in their electronic health record within 1 year of diagnosis. Eligible patients will receive patient-centered adaptive care strategies for their condition using Bayesian causal inference methods.

The primary outcome of interest is clinical response, measured by the Juvenile Arthritis Disease Activity Score at 3 years; active joint count, physician global assessment, parent global evaluation, and erythrocyte sedimentation rate will also be collected during office visits. The secondary outcome is quality of life. This study expects to enroll 1144 patients at the Cincinnati Children’s Hospital Medical Center, OH. For more information, contact Michelle R. Adams, PhD, at 513-803-7732 or michelle.adams@cchmc.org. The NLM Identifier is NCT02524340.

3 Phase 3 Trial Evaluates Tofacitinib Efficacy in Patients with Juvenile Idiopathic Arthritis

Researchers behind this double-blind, randomized phase 3 trial are evaluating the efficacy, safety, and tolerability of tofacitinib in the treatment of children and adolescents with polyarticular course JIA. Girls and boys aged 2 to 18 years may be eligible for inclusion if other criteria are met, including meeting ILAR JIA diagnostic criteria for one of the following categories, with active disease for ≥6 weeks: extended oligoarthritis, polyarthritis, systemic JIA with active arthritis and without active systemic features 6 months before and at time of study enrollment, psoriatic arthritis, and enthesitis-related arthritis.

During the open-label run-in phase, patients will be randomized to receive tofacitinib tablets or solution twice daily. In the double-blind, placebo-controlled phase, patients will receive active tofacitinib tablets/solution, or matching placebo tablets/solution, twice daily, based on their body weights. The primary outcome is occurrence of disease flare per Pediatric Rheumatology Collaborative Study Group and Paediatric Rheumatology International Trials Organisation criteria at 26 weeks during the double-blind phase. Secondary outcomes include time to disease flare, taste acceptability of tofacitinib oral solution, and JIA American College of Rheumatology (ACR) 30, 50, 70, 90, and 100 response. Approximately 265 patients will be enrolled at multiple locations across the United States. For more information, contact the Pfizer CT.gov Call Center at 800-718-1021. The NLM Identifier is NCT02592434.

4 Safety, Efficacy of First-Line Canakinumab Use in Pediatric Patients

The purpose of this phase 3 open-label study is to determine the safety and efficacy of canakinumab dose reduction and interval prolongation in patients with systemic JIA. A subgroup of patients of both sexes from the extension study CACZ885G2301E1 who are aged between 2 and 20 years may be eligible for study inclusion if other criteria are met. In cohort 1, criteria include patients who received canakinumab treatment for systemic JIA, and had inactive disease during their last visit in the extension study. In cohort 2, criteria include a confirmed diagnosis of systemic JIA and active systemic JIA.

In the first part of the study, all patients will receive canakinumab 4 mg/kg every 4 weeks, whereas in the second part of the study, patients will receive canakinumab at a reduced dose or dose interval prolongation. The primary outcome is the proportion of patients taking canakinumab who are in clinical remission and remain at an initial reduced canakinumab dose or prolonged canakinumab dose interval during part 2 of the study. Long-term safety and tolerability of cana­kinumab based on adverse events (AEs) is the secondary outcome of the study.

The investigators expect to enroll 180 patients at multiple locations across the United States and abroad. For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT02296424.

5 Empowering Patients Toward Employment

The purpose of this single-blind study is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention to improve self-efficacy, career maturity, and social support among adolescent and young adult patients with physical disabilities (eg, juvenile arthritis) and their parents. Teenaged and adult patients aged 15 to 25 years may be eligible for inclusion if other criteria are met; these include being able to read and write English, diagnosis of a physical disability, access to a computer and the Internet, and no paid work experience. Eligible patients will be randomized to receive a mentor-based intervention empowering them toward employment (treatment group), or access to employment activities without a mentor (control).

Patients in the treatment group will partake in a behavioral electronic intervention with trained mentors who will facilitate employment readiness learning and engage patients in discussions for 12 weeks. The primary outcome of measure is changes to scores from the Career Maturity Inventory Attitude Scale. Secondary outcome measures are changes according to the family empowerment scale, multidimensional scale of perceived social support, and Arc’s self-determination scale.

Approximately 160 patients will be enrolled in this study at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. For more information, contact Sally Lindsay, PhD, at 416-425-6220 (ext. 3654) or slindsay@hollandbloorview.ca. The NLM Identifier is NCT02522507.

6 Massage Therapy for Patients with Juvenile Idiopathic Arthritis Experiencing Pain

As part of this randomized, controlled, single-center, pilot study, investigators seek to assess the feasibility of an at-home massage therapy program in children with JIA who experience pain. Girls and boys aged 5 to 17 years may be eligible for inclusion if other criteria are met; these include a JIA diagnosis per ILAR classification, the ability to speak French or English, presence of pain, absence of anticipated change in treatment, and stable dosages of medications.

Eligible patients will be randomized to receive massage therapy by a caregiver for 15 minutes every night at bedtime for the span of 2 weeks along with standard care, or standard care only. The primary outcomes are recruitment rate, retention rate, and program adherence, as well as suggestions for improving the intervention, and user acceptability and satisfaction, which will all be measured at 1 year to determine the feasibility of the program. Secondary outcomes include daily pain, fatigue, stiffness, and sleep quality, as well as health-related quality of life, and caregiver’s psychological distress. The primary outcome of interest is clinical inactive disease at 12 months. Secondary outcomes are patient- and caregiver-reported outcomes compared using the Patient Reported Outcomes Measurement Information System.

Thirty people are expected to be enrolled as part of the study at the Montreal Children’s Hospital, Quebec, Canada. For more information, contact Sarah Campillo, MD, at 514-412-4400 (ext. 24268) or sarah.campillo@muhc.mcgill.ca. The NLM Identifier is NCT02218580.

7 Safety and Efficacy of Subcutaneous Tocilizumab in Patients with Systemic and Polyarticular Juvenile Idiopathic Arthritis

The purpose of this phase 1, open-label, nonrandomized trial is to examine the safety and efficacy of using subcutaneous tocilizumab in patients with polyarticular and systemic JIA. Patients from both sexes aged 2 to 18 years may be eligible for inclusion if other criteria are met, including having completed participation in 1 of 4 previous studies for this patient population, satisfactory disease control with subcutaneous tocilizumab, and no history of (or current) cancer or lymphoma.

Patients eligible for participation will be given tocilizumab 162 mg at varying intervals—dependent on their type of JIA—until the drug becomes commercially available, or after 3 years (whichever is earlier). Primary outcome measures of the trial are the number of patients with AEs, serious AEs, AEs of special interest, and inactive disease or clinical remission. Investigators behind the study will also be looking for changes in Juvenile Arthritis Disease Activity and Childhood Health Assessment Questionnaire scores.

Approximately 96 patients will be enrolled in this study at multiple locations across the United States and abroad. For more information, call 888-662-6728. The NLM Identifier is NCT02165345.

8 Resistance Exercise Training in Children and Young Adults with Juvenile Idiopathic Arthritis

Researchers behind this nonrandomized study are seeking to assess the safety and efficacy of resistance exercise training on muscle, bone, strength, symptoms, quality of life, and biological parameters in children and young adults with JIA. Patients from both sexes aged 10 to 21 years who meet ACR criteria for having polyarticular JIA, speak English, and are not cognitively impaired may be eligible for enrollment if other criteria are met.

Eligible patients will be placed in a resistance exercise cohort or a control group; those in the resistance exercise group will perform exercises once weekly using Ren-Ex Machines, whereas patients in the control group will be given educational materials about JIA and exercises recommended by the American Academy of Pediatrics Council on Sports Medicine and Fitness. Primary outcomes of interest are changes in body mass index, lower and upper extremity strength testing, and Total Body Dual-Emission X-ray Absorptiometry scans. Secondary outcome measures include changes in C-reactive protein and quality of life.

Patients are continuously being recruited for this trial at Johns Hopkins University in Baltimore, MD. For more information, contact Sangeeta Sule, MD, PhD, at 410-955-6145 or ssule@jhmi.edu. The NLM Identifier is NCT02479373.

9 Subcutaneous Tocilizumab for Patients with Systemic Juvenile Idiopathic Arthritis

The purpose of this randomized, phase 1, open-label, multicenter study is to examine the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in patients with systemic JIA. Girls and boys aged 1 to 17 years who have a diagnosis of systemic JIA per ILAR classification, a history of inadequate clinical response to nonsteroidal anti-inflammatory drugs and corticosteroids, and who are not wheelchair-bound or bedridden may be eligible for enrollment if other criteria are met.

Over the course of 52 weeks, eligible participants will be given a subcutaneous dose of tocilizumab based on their body weight; patients <30 kg will receive 162 mg once every 2 weeks, whereas those ≥30 kg will receive 162 mg once a week. The primary outcomes of interest are the minimum and maximum plasma concentrations of tocilizumab, and area under the concentration-time curve of the drug. Secondary outcome measures include the percentage of patients who experience ≥1 AEs, and serum interleukin (IL)-6 and soluble IL-6 receptor levels.

Forty-eight patients are expected to be enrolled in this trial at multiple locations across the United States and abroad. For more information, call 888-662-6728. The NLM Identifier is NCT01904292.

10 Long-Term Safety and Tolerability of Tofacitinib Use in Patients with Juvenile Idiopathic Arthritis

Researchers behind this phase 3, open-label, single-group study are assessing the long-term safety and tolerability of tofacitinib use in patients with JIA who have previously participated in studies relevant to this drug. Patients from both sexes who are aged 2 to 18 years may be eligible for enrollment if other criteria are met, including having previously participated in and completed a qualifying study of tofacitinib for treatment of JIA.

All eligible patients will receive oral tofacitinib twice daily—once each in the morning and evening—the dose of which is dependent on their body weight. The primary outcome measures are standard laboratory safety data and AE reports. Secondary outcomes of interest include physician global evaluation of disease activity, the number of joints with active arthritis, and JIA ACR response and occurrence of JIA ACR disease flare, all measured at each visit.

Researchers expect to enroll 290 patients in this study 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 NCT01500551.

11 Observational Registry of Abatacept Use in Patients with Juvenile Idiopathic Arthritis

Investigators in this prospective trial are seeking to observe the long-term safety of abatacept use in patients with JIA, with a focus on occurrences of serious infections, autoimmune disorders, and malignancies. Children and teenagers aged ≤17 years who have a diagnosis of any subtype of JIA may be eligible for study enrollment if other criteria are met. Eligible participants will be treated with abatacept. Primary outcomes of interest are the incidence rates of serious infections, malignancies, and autoimmune disorders. Secondary outcome measures are the number of serious AEs and targeted infections. Approximately 900 patients will be enrolled in this study at multiple locations across the United States and abroad. For more information, e-mail clinical.trials@bms.com. The NLM Identifier is NCT01357668.

12 Comparing the Efficacy of Biologic Start Times in Patients with Polyarticular Juvenile Idiopathic Arthritis

Researchers behind this prospective, observational study will be comparing the clinical effectiveness of 3 unique consensus-derived treatment strategies in patients with new-onset polyarticular JIA, as well as the impact they have on patient-reported outcomes, with the goal of answering the critical question of when to start biologic medications. Patients from both sexes aged 2 to 18 years may be eligible for inclusion if other criteria are met, including having a diagnosis of arthritis as defined by the ACR, arthritis in 1 joint for ≥6 weeks, and ≥5 active joints at baseline.

All eligible patients will be enrolled in the Childhood Arthritis & Rheumatology Research Alliance Registry and given 1 of 3 treatment options, based on the preference of their treating physician and parent or caregiver. Primary and secondary outcome measures are clinical inactive disease and patient- and caregiver-reported outcomes, respectively.

Researchers expect to enroll 400 patients in this study at multiple locations across the United States and in Canada. For more information, contact Mary Ellen Riordan, BSN, at 551-996-8126 or mriordan@hackensackumc.org. The NLM Identifier is NCT02593006.

13 Decreased Dose Frequency of Tocilizumab in Patients with Systemic Juvenile Idiopathic Arthritis

The purpose of this open-label, phase 4, safety and efficacy trial is to examine the frequency of decreased dosing in patients with systemic JIA who experience laboratory abnormalities while receiving tocilizumab. Boys and girls aged 2 through 17 years who have systemic JIA per ILAR classification; symptoms of systemic JIA that last for ≥1 months since diagnosis; and no active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infections may be eligible for enrollment if other criteria are met.

Those eligible for enrollment will receive tocilizumab 12 mg/kg or 8 mg/kg once every 2, 3, or 4 weeks, depending on their body weight. The primary outcomes of interest researchers will be looking for are the number of patients with AEs and JIA disease flare, those who develop a fever in the second part of the study, and Juvenile Arthritis Disease Activity scores at the end of the second part of the study. Secondary outcome measures include the minimum and maximum observed plasma concentrations, C-reactive protein concentrations, and changes from baseline in the JIA component scores of patient and parent global assessments of overall well-being. Sixty-five patients are expected to enroll in this trial at multiple locations across Canada and abroad. For more information, call 888-662-6728. The NLM Identifier is NCT01734382.

14 Intravenous Golimumab for Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis

Investigators in this phase 3, single-group, open-label trial are seeking to evaluate the pharmacokinetics of intravenous (IV) golimumab administered to pediatric patients with polyarticular JIA. Children and young adults aged 2 to 18 years who have a diagnosis of JIA per ILAR criteria, experienced onset of the disease prior to turning age 16, and have ≥5 joints with active arthritis at screening and week 0 per ACR criteria may be eligible for enrollment in the study if other necessary criteria are met.

Eligible patients will receive IV golimumab at weeks 0 and 4, and every 8 weeks up to week 244; up to week 28 this will be administered with a weekly dose of methotrexate. The primary outcome measures are the serum trough concentration of the drug at week 28, and Bayesian area under the curve at steady state over a dosing interval of 8 weeks. Secondary outcomes of interest are the serum trough concentration of the drug, and Bayesian area under the curve at steady state, measured at week 52.

Approximately 120 patients will be enrolled in this study at multiple locations across the United States and abroad. For more information, e-mail JNJ.CT@sylogent.com. The NLM Identifier is NCT02277444.

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