Select Ongoing Trials Currently Enrolling Patients with Rheumatoid Arthritis

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 patients with rheumatoid arthritis. 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 Otilimab versus Placebo plus Tofacitinib in Moderate- to-Severe Active Rheumatoid Arthritis with Inadequate Response to csDMARDs

The purpose of this randomized, multicenter, double-blind, phase 3 clinical trial is to assess the safety and efficacy of otilimab (GSK3196165) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARDs previously. Patients aged ≥18 years who have had RA for ≥6 months with at least 1 bone erosion present on hand/wrist or foot radiographs and inadequate response to csDMARDs may be eligible if other criteria are met. Eligible patients will be randomized to receive otilimab 90 mg or 150 mg by subcutaneous injection once weekly plus a stable dose of csDMARDs; tofacitinib (Xeljanz) 5-mg tablet orally (PO) twice daily plus placebo injection plus stable csDMARDs; or otilimab 90 mg subcutaneously plus placebo injection or otilimab 150 mg subcutaneously plus placebo injection.

The primary outcome measure is the proportion of patients achieving 20% improvement in the American College of Rheumatology Criteria (ACR20) at week 12 over placebo. Secondary outcome measures include the proportion of patients achieving Clinical Disease Activity Index (CDAI) score ≤10 at weeks 12, 24, and 52; change in baseline arthritis pain at weeks 12, 24, and 52; and change in baseline of lipid panel, clinical chemistry, hematology, and fatigue at weeks 12, 24, and 52. This study expects to enroll 1500 participants throughout the United States and worldwide. For more information, contact the GSK Clinical Trials Call Center at 1-877-379-3718 or GSK ClinicalSupportHD@gsk.com. The NLM identifier is NCT04333147.

2 Olokizumab versus Placebo in Patients with RA Currently Receiving TNF-alpha Inhibitor with Active Disease

The purpose of this randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial is to study the safety, tolerability, and efficacy of a double dose of olokizumab in patients with moderate-to-severe active RA who have not responded to tumor necrosis factor (TNF)-alpha inhibitor therapy. Patients aged ≥18 years with adult-onset RA for ≥24 weeks prior to screening who have received methotrexate for at least 12 weeks and are able to take folic acid throughout the study may be eligible if other criteria are met. Eligible patients are randomized to receive olokizumab 64 mg subcutaneous every 4 weeks plus methotrexate PO, or olokizumab 64 mg subcutaneously every 2 weeks plus methotrexate PO, or placebo subcutaneously every 2 weeks plus methotrexate PO.

The primary outcome measure is ACR20 response at 12 weeks. Secondary outcome measures include ACR50 response at week 12, Simplified Disease Activity Index ≤3.3 (remission), and the difference between olokizumab and placebo in the improvement of physical ability. This study expects to enroll 350 participants throughout the United States and worldwide. For more information, contact Mikhail Samsonov, MD, at 1-609-512-1739 or contactus @rpharm-us.com. The NLM identifier is NCT02760433.

3 Adalimumab-Pfizer and Humira in Combination with Methotrexate in Active RA

The purpose of this randomized comparative phase 3 clinical trial is to assess the impact of pharmacokinetics, safety, and immunogenicity after switches from adalimumab-Pfizer (PF-06410293) and adalimumab (Humira), and with continuous dosing of adalimumab in combination with methotrexate in patients with moderate-to-severe active RA. Patients aged 18 to 70 years with diagnosed RA based on ACR/European League Against Rheumatism (EULAR) 2010 scoring may be eligible if other criteria are met. Eligible patients will be randomized to receive either subcutaneous injection of adalimumab-Pfizer plus adalimumab or adalimumab monotherapy.

The primary outcome measures are Cmax obtained during weeks 30 to 32 and area under the curve obtained during weeks 30 to 32. Secondary outcome measures include other pharmacokinetic parameters, number of patients with treatment-related adverse events, number of patients with clinically significant change in laboratory tests, and the percentage of participants with antidrug antibodies (ADA)/neutralizing antibody (NAB) titers over time. This study expects to enroll 420 participants throughout the United States and worldwide. For more information, contact Pfizer CT.gov Call Center at 1-800-718-1021 or at ClinicalTrials.gov_In quiries@pfizer.com. The NLM identifier is NCT04230213.

4 Rituximab Biosimilar Transition to and from US-Rituximab/EU-Rituximab in RA

The purpose of this randomized, double-blind, multicenter phase 3 clinical trial is to assess the immunogenicity and safety of transitioning patients with RA from rituximab biosimilar to US-rituximab (Rituxan)/EU-rituximab (Mabthera) to continued treatment with US-rituximab/EU-rituximab. Patients aged ≥18 years with active RA and are eligible to receive US-rituximab or EU-rituximab according to investigator assessment, and who have been receiving a stable dose of weekly methotrexate for ≥4 weeks prior to randomization may be eligible if other criteria are met.

Primary outcome measures include ADA, titer, and NAB incidence throughout the study period and incidences of treatment-emergent adverse events, safety adverse events, hypersensitivity reactions, and anaphylactic reactions throughout the study period. This study expects to enroll 140 participants in the United States and worldwide. For more information, contact Narendra Maharaj, MBBS, MD, at narendra maharaj@drreddys.com or Sonica Sachdeva Batra, MD, DNB, at soni cabatra@drreddys.com. The NLM identifier is NCT04268771.

5 Otilimab versus Placebo and Sarilumab in Moderate-to->Severe RA with Inadequate Response to csDMARDs and/or JAK Inhibitors

Similar to the previously mentioned clinical trial, the purpose of this randomized, multicenter, double- blind phase 3 clinical trial is to assess the safety and efficacy of otilimab (GSK3196165) in combination with csDMARDs versus sarilumab (Kevzara) and placebo for the treatment of adult patients with moderate-to-severe active RA who have had inadequate responses to DMARDs and/or JAK inhibitors. Patients aged ≥18 years who have been diagnosed with RA for ≥6 months with active disease and inadequate response to csDMARDs for ≥12 weeks may be eligible if other criteria are met. Eligible patients will be randomized to receive otilimab by subcutaneous injection weekly with stable doses of csDMARDs with or without placebo, or sarilumab 200 mg by subcutaneous injection every other week plus placebo by subcutaneous injection in intervening weeks with stable doses of csDMARDs.

The primary outcome measure is the proportion of patients achieving ACR20 at week 12. Secondary outcome measures include changes from baseline activities of daily living, CDAI total score, fatigue, and arthritis pain at weeks 12 and 24; proportion of patients achieving ACR50, ACR70, and good/moderate EULAR response at weeks 12 and 24; and the proportion of participants with Common Terminology Criteria for Adverse Events grade ≥3 hematologic/clinical chemistry abnormalities. The study expects to enroll 525 participants throughout the United States and worldwide. For more information, contact US GSK Clinical Trials Call Center at 1-877-379-3718 or GSK ClinicalSupportHD@gsk.com. The NLM identifier is NCT04134728.

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