Clinical Research Studies

At Arthritis and Rheumatic Diseases Specialties, we continually contribute to the development of new protocols and treatments for diseases by participating in clinical research. Clinical research allows us to achieve two important goals: to help patients who need treatment options in the short term, and to contribute to the approval of better treatment protocols in the long term. The valuable information learned from a clinical research trial provides medical knowledge about the risks and benefits of medications which can make a difference in the care of future patients. Participating in clinical research also provides an opportunity for patients to receive the newest treatment options and to have additional care of attention from the clinical research medical staff.

If you or anyone you know has been diagnosed with an autoimmune disorder including Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis, Ankylosing Spondylitis, Osteoarthritis, and Gout and may be interested in participating in a clinical research trial, please call the Research Department at 305-932-4295 to discuss the inclusion and exclusion criteria for participation in a clinical trial.

These links will take you to the description of the clinical trials being conducted currently in the office under the clinical trials.gov website. You can read about the specific trial and see the Inclusion/Exclusion criteria to see if you qualify to participate.

Rheumatoid Arthritis:

• Vorso Corp – Protocol VC2020-7: Researching the safety and efficacy the Vorso PROTECT System for the treatment of subjects with active rheumatoid arthritis who are naïve to biologic or synthetic disease modifying agents (recruiting) Note: We have had experience with Vegas nerve stimulation and have had positive results. This is a similar device, however it is a non-invasive customized earbud (controlled by a smartphone), which generates electrical impulses that are delivered to the ear with the hope of reducing the inflammatory symptoms of rheumatoid arthritis. Participants will use the device once a day for 15 minutes. The technology is new and the latest in treatment options for rheumatoid arthritis.
• GlaxoSmithKline group of companies – Protocol 201791: Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic DMARDs (ongoing)
• Gilead Sciences, Inc – Protocol GS-US-417-0304: A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis (ongoing)
• SetPoint Medical – Protocol SPM-011: Long Term Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients with Rheumatoid Arthritis (ongoing)
• AbbVie – Protocol M14 465: A Phase 3, Randomized, Double-Blinded Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who have an Inadequate Response to MTX (MTX-IR) (ongoing)
• AbbVie – Protocol M13 538: Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Precending Phase 2 Randomized Controlled Trial (RCT) with ABT-494 (ongoing)

Systemic Lupus Erythematosus:

• Amgen – Protocol 20200234: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus with Inadequate Response to Standard of Care Therapy (recruiting)
• AstraZeneca AB – Protocol D3465C00001: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (recruiting)
  
• UCB Biopharma SRL – Protocol SL0043: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active Systemic Lupus Erythematosus (recruiting)
• Biogen – Protocol 230LE303: A Multicenter, Randomized, Double- Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care (recruiting)
• Eli Lilly and Company – Protocol I4V-MC-JAHZ: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in patients with Systemic Lupus Erythematosus (ongoing)
• AbbVie – Protocol M19-130: A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus (ongoing)
  
• Bristol-Myers Squibb Research and Development – Protocol IM011021: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus (Pro00025742) (ongoing)

Gout:

• Horizon – Protocol HZNP-KRY-405: A Phase 1b, Combined Single-Dose and Multiple-Dose, Multicenter, Randomized, Open-Label Trial to Assess Safety and Tolerability of Two Different Dose Levels of Subcutaneous Pegloticase in Subjects with Uncontrolled Gout Receiving Methotrexate (recruiting)

Psoriatic Arthritis (PsA):

• AbbVie – Protocol M15-554: A Phase 3, Randomized, Double-Blind, Study Comparing (ABT-494) to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) – SELECT – PsA (ongoing)

Osteoarthritis:

If you or anyone you know has been diagnosed with an autoimmune disorder including Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis, Ankylosing Spondylitis and Gout and may be interested in participating in a clinical research trial, please call the Research Department at 305-652-6676 to discuss the inclusion and exclusion criteria for participation in a clinical trial

• Organogenesis – Protocol 19 OA 001 ASA: A Phase 3 Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients with Osteoarthritis of the Knee (recruiting)

Axial Spondylitis:

• AbbVie – Protocol M19-944: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis (ongoing)