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Select Ongoing Trials Currently Enrolling Patients with Rheumatoid Arthritis

Rheumatology Practice Management August 2017 Vol 5 No 4 - Clinical Trials Tracker

The following clinical trials represent a selection of key studies that are currently recruiting patients with rheumatoid arthritis 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 and Efficacy of PF-06650833 in Patients with Inadequate Responses to Methotrexate

The objective of this randomized, double-blind, parallel-assignment phase 2 clinical trial is to evaluate the safety and efficacy of using PF-06650833 for 12 weeks for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA) whose condition inadequately responded to methotrexate. Patients aged 18 to 70 years with a diagnosis of RA in accordance with 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive PF-06650833, tofacitinib, or placebo.

The primary outcome measure is a change in the Simplified Disease Activity Index (SDAI) from baseline to week 12. Secondary outcome measures include changes from baseline to weeks 4, 8, and 12 in SDAI low disease activity scores, ACR50 and ACR70 responder rates, and the Physician’s Global Assessment of Arthritis. This study plans to enroll 230 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 NCT02996500.

2. Disease Remission Following Discontinuation of Tumor Necrosis Factor Inhibitor Treatment

This randomized, double-blind, parallel-assignment phase 4 clinical trial will determine whether RA remission can endure following discontinuation of therapy with a tumor necrosis factor (TNF) inhibitor, and whether a patient’s potential for disease flare or maintaining disease remission can be predicted with the use of clinical, imaging, and immunologic measurements. Patients aged ≥18 years with RA diagnosed in accordance with 1987 ACR criteria who are not currently receiving treatment with golimumab or certolizumab and whose disease has been in remission for 6 months through the use of etanercept, infliximab, or adalimumab may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive matched placebo or their currently used anti-TNF inhibitor agent. Clinical assessments will be performed every 12 weeks.

The primary outcome measure is remission of RA over a 48-week time frame, based on Disease Activity Score 28 (DAS28) based on joints. The secondary outcome measures are changes in Health Assessment Questionnaire Disability Index and Sharp-van der Heijde radiographic score, both at 48 weeks. This study expects to enroll 290 patients at the Georgetown University Medical Center, Washington, DC. For more information, contact Arthur Weinstein, MD, at 202-877-6274 or aw89@georgetown.edu, or Michael M. Ward, MD, at 301-496-7263 or wardm1@mail.nih.gov. The NLM Identifier is NCT01793519.

3. Effect of Tofacitinib on Musculoskeletal Ultrasound Measures in Patients with Rheumatoid Arthritis

The objective of this open-label, single-group, interventional phase 4 clinical trial is to assess whether treatment with tofacitinib for 3 months leads to an improvement in musculoskeletal ultrasound measures or multibiomarker disease activity in patients with RA. The trial will also seek to determine whether early musculoskeletal ultrasound measures or multibiomarker disease activity can be used to predict therapy responses. Patients aged ≥18 years with a diagnosis of RA in accordance with 1987 ACR criteria and a power Doppler score of ≥10 may be eligible for enrollment if other criteria are met. Eligible patients will be given oral tofacitinib twice daily.

The primary outcome measure is a change in musculoskeletal ultrasound score at baseline, 1 month, and 3 months. The secondary outcome measure is a change in multibiomarker disease activity at baseline, 1 month, and 3 months. This study plans to enroll 25 patients at the University of California Los Angeles David Geffen School of Medicine, Division of Rheumatology. For more information, contact Veena K. Ranganath, MD, MS, at 310-825-3061 or vranganath@mednet.ucla.edu, or Gabriel Valdivia at 310-794-9504 or gvaldivia@mednet.ucla.edu. The NLM Identifier is NCT02321930.

4. Safety and Efficacy of Proposed Infliximab Biosimilar

This randomized, double-blind, multicenter, crossover-assignment phase 3 clinical trial will validate the similarities in safety and efficacy between NI-071, a biosimilar drug, and its reference drug, infliximab, in patients with RA whose disease did not respond adequately to methotrexate. Patients aged 18 to 75 years with RA diagnosed in accordance with 2010 ACR and EULAR classification criteria who have been receiving oral or parenteral methotrexate for ≥3 months before trial screening may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive NI-071 or infliximab.

The primary outcome measures are a 20% improvement in ACR core set criteria from baseline to week 22, maximum concentration, long-term safety, and the area under the plasma concentration–time curve for a dosing interval. Secondary outcome measures include 20%, 50%, and 70% improvements in ACR core set criteria from baseline to week 62; changes in the Medical Outcomes Study 36-Item Short-Form Health Survey; and time at maximum concentration. This study expects to enroll 585 patients at multiple locations across the United States. For more information, contact hiroshi-bando@nichiiko.co.jp. The NLM Identifier is NCT02990806.

5. Safety, Tolerability, and Pharmacokinetics of MEDI4920 in Patients with Adult-Onset Rheumatoid Arthritis

The objective of this randomized, parallel-assignment, double-blind phase 1 clinical trial is to demonstrate the safety and tolerability of using MEDI4920 for the treatment of patients with adult-onset RA. Patients aged 18 to 70 years with a diagnosis of adult-onset RA, swollen and tender joints, and no active or untreated latent tuberculosis may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive MEDI4920 or placebo.

The primary outcome measures are the occurrence of adverse events and severe adverse events over a 24-week time frame. The secondary outcome measures are a summarization of positive antidrug antibodies against MEDI4920, peak plasma concentration, and the area under the plasma concentration-time curve, over a time frame of 24 weeks. This study plans to enroll 40 patients at multiple locations across the United States and in Poland. For more information, contact the AstraZeneca Clinical Study Information Center at 877-240-9479 or information.center@astrazeneca.com. The NLM Identifier is NCT02780388.

6. Long-Term Safety, Tolerability, and Efficacy of Filgotinib

This randomized, double-blind, multicenter, parallel-assignment phase 3 clinical trial will evaluate the long-term safety, tolerability, and efficacy of filgotinib in patients with RA. Patients aged ≥18 years with a diagnosis of RA and who have no other autoimmune or inflammatory joint diseases may be eligible for enrollment if other criteria are met. Eligible patients will receive filgotinib.

The primary outcome measures are the percentages of patients who have adverse events and significant laboratory abnormalities. The secondary outcome measure is the number of patients who achieve ACR-N responses in the trial arms. This study expects to enroll 2800 patients at multiple locations across the United States. For more information, contact the Gilead Study Team at 866-645-3230 or FINCHstudies@gilead.com. The NLM Identifier is NCT03025308.

7. LY3337641 for the Treatment of Adults with Rheumatoid Arthritis

The objective of this randomized, parallel-assignment, double-blind phase 2 clinical trial is to assess the safety and efficacy of using LY3337641 for the treatment of adult patients with RA. Patients aged 18 to 65 years with RA diagnosed in accordance with 2010 ACR and EULAR classification criteria who have no known hypogammaglobulinemia or active tuberculosis may be eligible for enrollment if other criteria are met. Eligible patients will receive oral LY3337641.

The primary outcome measures are the percentage of patients who have ≥1 adverse events or serious adverse events associated with the trial drug, and the number of patients who achieve an ACR20 improvement. Secondary outcome measures include changes in DAS28 C-reactive protein from baseline, and the percentage of patients who achieve ACR50 and ACR70 improvements. This study plans to enroll 276 patients at multiple locations across the United States and abroad. For more information, contact 877-285-4559 or 317-615-4559. The NLM Identifier is NCT02628028.

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Last modified: October 3, 2017
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