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Rheumatology Practice Management February 2017 Vol 5 No 1 - Clinical Trials Tracker

The following clinical trials represent a selection of key studies that are currently recruiting patients with psoriatic 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 Bimekizumab

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to evaluate the safety and efficacy of using bimekizumab in patients with active psoriatic arthritis (PsA). Patients aged ≥18 years with a high- sensitivity C-reactive protein equal to or greater than the upper limit of normal who have been diagnosed with adult-onset PsA in accordance with the Classification Criteria for PsA (CASPAR) standards may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive bimekizumab or placebo.

The primary outcome measure is American College of Rheumatology 50% (ACR50) improvement response at week 12. Secondary outcome measures are ACR20 and ACR70 improvement responses, and Psoriasis Area Severity Index 75 (PASI75) and PASI90 responses, all taken at week 12. This study plans to enroll 200 patients at locations in Florida, Texas, Connecticut, Rhode Island, Tennessee, and Pennsylvania. For more information, contact UCB Cares at 877-822-9493. The NLM Identifier is NCT02969525.

2. 2-Year Safety, Efficacy, and Tolerability of Subcutaneous Secukinumab

This randomized, double-blind, placebo-controlled, phase 3 clinical trial will assess the safety, efficacy, and tolerability of using subcutaneous secukinumab for up to 2 years in the treatment of patients with active PsA. Patients aged ≥18 years who meet CASPAR standards for a diagnosis of PsA and are not taking any high-potency opioid analgesics may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive subcutaneous secukinumab 150 mg or 300 mg, or placebo.

The primary outcome measure is ACR20 response at week 16. Secondary outcome measures include the presence of enthesitis and dactylitis, as well as PASI75 and PASI90 responses, at week 16. ACR50 responses, Health Assessment Questionnaire-Disability Index scores, Disease Activity Score 28 Joints, and Van der Heijde modified total Sharp scores will also be measured as secondary end points. This study expects to enroll 990 patients at multiple locations across the United States and abroad. For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT02404350.

3. Etanercept and Methotrexate as Monotherapies versus as a Combination Treatment

The purpose of this randomized, double-blind, multicenter, phase 3 clinical trial is to compare the use of etanercept and methotrexate as monotherapies, as well as in combination with each other in patients with PsA. Patients aged ≥18 years with an active psoriatic skin lesion who have been diagnosed with PsA in accordance with CASPAR standards may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive etanercept alone, methotrexate alone, or etanercept in combination with methotrexate.

The primary outcome measure is the efficacy of the various therapy regimens, based on ACR20 response at week 24. Secondary outcome measures are Minimal Disease Activity responses for arthritis activity, nonarthritic PsA disease activity, and patient-reported outcomes at week 24. This study plans to enroll 840 patients at multiple locations across the United States and abroad. For more information, contact the Amgen Call Center at 866-572-6436. The NLM Identifier is NCT02376790.

4. Safety, Efficacy, and Tolerability of Risankizumab in Patients Who Have Completed Study 1311.5

This single-arm, open-label, extension, phase 2 clinical trial will assess the safety, efficacy, and tolerability of using risankizumab for the treatment of patients with PsA who completed 24 weeks of therapy in Study 1311.5. Patients aged ≥18 years who participated in and completed all study drug doses involved in Study 1311.5 may be eligible for enrollment if other criteria are met. Eligible patients will receive subcutaneous risankizumab.

The primary outcome measure is the occurrence of adverse events. Secondary outcome measures include ACR20 responses and changes in Modified Total Sharp Scores from baseline. This study expects to enroll 180 patients at multiple locations across the United States and in Canada. For more information, contact the AbbVie Call Center at 847-283-8955. The NLM Identifier is NCT02986373.

5. Methotrexate Combined with Adalimumab versus Methotrexate Monotherapy

The objective of this 2-part, randomized, open-label, phase 4 clinical trial is to compare the achievement of minimal disease activity in patients with PsA randomized to receive treatment with methotrexate plus adalimumab versus methotrexate monotherapy escalated to the highest recommended or tolerable dose.

The second part of the trial will evaluate the achievement or preservation of minimal disease activity with 4 unique treatment regimens consisting of adalimumab and/or methotrexate. Patients aged 18 to 99 years who were diagnosed with PsA in accordance with CASPAR standards ≥4 weeks before being screened for eligibility in this trial may qualify to enroll if other criteria are met. Eligible patients will be randomized to receive adalimumab, methotrexate, or adalimumab in combination with methotrexate.

The primary outcome measure is the percentage of participants who achieve minimal disease activity at week 16. Secondary outcome measures include the number of participants who achieve ACR20, ACR50, and ACR70 responses, as well as those who experience a change in tender dactylitic digit count from baseline. This study plans to enroll 240 patients at multiple locations across the United States and abroad. For more information, contact Erica Cummings at 847-937-1246 or erica.cummings@abbvie.com, or Aurore Diamand at aurore.diamand@abbvie.com. The NLM Identifier is NCT02814175.

6. Safety and Efficacy of Various Doses of Subcutaneous Risankizumab

This randomized, double-blind, placebo-controlled, phase 2 clinical trial will assess the safety and efficacy of using various subcutaneous doses of risankizumab for the treatment of adult patients with PsA. Patients aged ≥18 years who were diagnosed with PsA in accordance with CASPAR standards ≥6 months before being screened for eligibility in this trial may qualify to enroll if other criteria are met. Eligible patients will be randomized to receive subcutaneous risankizumab at high, medium high, medium, or low doses, or placebo.

The primary outcome measure is ACR20 response at week 16. Secondary outcome measures include ACR50 and ACR70 responses at week 16, and changes in dactylitis count at week 16 compared with baseline values. This study expects to enroll 180 patients at multiple locations across the United States and abroad. For more information, contact Krista Bodary at krista.bodary@abbvie.com. The NLM Identifier is NCT02719171.

7. Safety, Efficacy, and Tolerability of Tofacitinib

The purpose of this extension, open-label, phase 3 clinical trial is to assess the safety, efficacy, and tolerability of using tofacitinib for the treatment of patients with active PsA who have already participated in randomized trials of this drug. Patients aged ≥18 years who previously participated in a clinical trial of tofacitinib for patients with PsA may be eligible for enrollment if other criteria are met. Eligible patients will receive oral tofacitinib 5 mg or 10 mg twice daily.

The primary outcome measures are the proportion of participants who experience adverse events or serious adverse events, and laboratory test results that are deemed clinically significant. The secondary outcome measures include the number of participants who achieve ACR20, ACR50, and ACR70 responses, as well as participants who achieve PsA Response Criteria. This study plans to enroll 650 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 NCT01976364.

8. Evaluation of Injection Site Pain Associated with New Etanercept Formula

This randomized, double-blind, multicenter, phase 4 clinical trial will compare the occurrence of injection site pain in patients with PsA using a new formulation of etanercept versus the commercial formulation of etanercept. Patients aged ≥18 years who are diagnosed with PsA and are naïve to etanercept may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive a dose each of commercial and new etanercept formulations.

The primary outcome measure is the number of participants who experience injection site pain according to a visual analog scale. The safety of the new etanercept formulation will also be measured via the number of participants who have adverse events. This study expects to enroll 90 patients at multiple locations across the United States. For more information, contact the Amgen Call Center at 866-572-6436. The NLM Identifier is NCT02986139.

9. Safety, Tolerability, and Pharmacokinetics of Apremilast

The objective of this open-label, multicenter, phase 2 clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of using apremilast for the treatment of pediatric patients with severe plaque psoriasis. Patients aged 6 to 17 years with a PASI score ≥12 and a serum creatinine level of ≤1.2 times the upper limit of normal for their age and sex may be eligible for enrollment if other criteria are met. Eligible patients will receive oral apremilast 10 mg, 20 mg, or 30 mg.

The primary outcome measures are the number of participants who experience adverse events, and multiple aspects of the drug’s pharmacokinetics. The secondary outcome measures are the taste and acceptability of apremilast, according to the results of an assessment using Likert Scale faces. This study plans to enroll 32 patients at multiple locations across the United States and abroad. For more information, contact the Associate Director of Clinical Trial Disclosure at 888-260-1599 or clinicaltrialdisclosure@celgene.com. The NLM Identifier is NCT02576678.

10. Safety and Efficacy of Subcutaneous Secukinumab Compared with Placebo

This randomized, double-blind, placebo-controlled, phase 4 clinical trial will assess the safety and efficacy of using secukinumab for the treatment of patients with active PsA. Patients aged ≥18 years who meet CASPAR standards for a diagnosis of PsA may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive subcutaneous secukinumab 150 mg or 300 mg, or placebo.

The primary outcome measure is the percentage of participants who achieve ACR20 response criteria with secukinumab 300 mg compared with placebo. Secondary outcome measures include the percentage of participants who achieve ACR20 response criteria with secukinumab 150 mg compared with placebo, and the percentage of participants who achieve a PASI75, PASI90, or PASI100 response. This study expects to enroll 250 patients at locations in California, Texas, Florida, South Carolina, and Tennessee. For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT02798211.

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Last modified: March 30, 2017
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