CLINICAL TRIALS
You deserve the best care — it’s as simple as that. We at ARBDA are passionate about staying at the forefront of medical advances to better serve our patients facing arthritis and autoimmune disorders. By actively participating in clinical trials, we’re able to bring you the latest, most promising treatments for conditions like osteoarthritis, rheumatoid arthritis, lupus, and more.
Our commitment to innovation and compassionate care means that you’re not only getting expert guidance but also access to cutting-edge therapies that could transform your quality of life. We’re here to support you every step of the way, with care rooted in the latest research and a deep understanding of your needs.
WHAT IS A CLINICAL TRIAL?
IS A CLINICAL TRIAL GOOD FOR ME?
WHAT HAPPENS IN A CLINICAL TRIAL?
CURRENT STUDIES
RHEUMATOID ARTHRITIS — PHASE III INTERVENTIONAL STUDY
June 2023 through October 2025
Study ID#: M32-700
Sponsor: abbVie
ClinicalTrials.gov ID: NCT05814627
Study to Assess Change in Disease Activity and Adverse Events of RINVOQ® (upadacitinib) Compared to HUMIRA® (adalimumab) in Adult Participants with Moderate to Severe Rheumatoid Arthritis
This study is looking at how effective and safe the two currently FDA-approved medications, RINVOQ (upadacitinib) and HUMIRA (adalimumab), are for treating rheumatoid arthritis (RA), a condition that causes joint pain, stiffness, and swelling.
Participants in the study are adults whose RA has not responded well to a previous TNF-inhibitor, and who are being treated with methotrexate (MTX).
The study will compare these two medications, and participants will be randomly assigned to one of two patient groups. One group will take RINVOQ (a pill taken daily), while the other will take HUMIRA (an injection every other week). There is a 50% chance of being assigned to either medication. There is NO PLACEBO group in this clinical trial — so if you qualify for participation, you will be receiving effective medicine. However, neither the participants nor the doctors will know who is receiving which medication, which helps ensure the study is unbiased.
The study is divided into two parts, and participants will continue their assigned treatment throughout both periods. The effects of the medications will be assessed through regular medical checkups and questionnaires at the ARBDA–Voorhees office. Participants will be followed for an additional 30 to 70 days after the treatment period to monitor for side effects and changes in their symptoms.
CONTACT US ABOUT THIS CLINICAL TRIAL
SJOGRENS SYNDROME – PHASE III INTERVENTIONAL STUDY
January 2024 – May 2025
Study ID#: OASIZ-301
Sponsor: AMGEN
Clinicaltrials.gov Identifier: NCT06104124
[Click Here for More Information]
The Oasiz Studies are researching how safe and effective an experimental treatment, Dazodalibep, is for treating people with moderate-to-severe Sjögren’s syndrome. This new medicine works differently from the ones currently available, which mainly help manage symptoms. The goal of the study is to see if Dazodalibep can also slow down the progression of the disease.
The clinical study lasts up to 14 months (60 weeks) and involves up to 16 visits to the study site. After the main study period, participants may have the option to join an extension study, where everyone will receive the experimental treatment for a period of time.
During the study, you may be able to continue using the medication you are currently taking. The study doctor will provide more details.
About the Experimental Treatment: Participants will receive either Dazodalibep or a placebo through an IV about once a month. There is a 66% chance of receiving Dazodalibep and a 33% chance of receiving a placebo (which looks like the medicine but doesn’t contain any active ingredients).
You may be able to participate if you:
- Are at least 18 years old
- Have been diagnosed with Sjögren’s
- Have moderate-to-severe symptoms like dry mouth, dry eyes, fatigue, joint pain, or other symptoms
The Oasiz Studies include two slightly different research groups:
- Oasiz-301 Study: This is for people who have the usual Sjögren’s symptoms (dryness, pain, and fatigue) and at least one other organ affected (such as lungs, kidneys, nerves, skin, etc.).
- Oasiz-303 Study: This is for people with typical Sjögren’s symptoms but with minimal involvement of other organs.
CONTACT US ABOUT THIS CLINICAL TRIAL
FREQUENTLY ASKED QUESTIONS ABOUT CLINICAL TRIALS
A clinical trial is a research study where volunteers receive medications under the supervision of a physician. They work closely with clinical research team members to evaluate how well they respond to a particular treatment.
Most clinical trials, including phase II and phase III trials, follow a structured protocol, which is approved by an Institutional Review Board to ensure safety and informed consent. These studies help gather preliminary data on new drugs, treatments, or medical devices, determining their effectiveness and potential health outcomes.
In most clinical trials, volunteers who meet the inclusion criteria are usually assigned to a specific patient group within the research study. Trials progress through phases:
- Phase I: Focuses on safety and dosage, often using healthy volunteers.
- Phase II: Assesses effectiveness for a specific disease, gathering more preliminary data.
- Phase III: Compares the new treatment to existing ones, using a larger participant group to confirm efficacy and monitor side effects.
- Phase IV: Conducted after FDA approval, tracking long-term safety and outcomes.
Informed consent is crucial so that participants understand the risks, benefits, and procedures before enrolling. Institutional Review Boards (IRBs) oversee trials to maintain ethical standards.
Clinical trials are key to medical advancement, giving patients access to new treatments while contributing to broader research efforts for improved healthcare. At ARBDA, we typically do not participate in trials involving placebos. This helps our patients gain access to new drugs and medical treatments being tested.
Clinical trials are the driving force behind medical progress. Participation in clinical trials is essential for researchers to gather preliminary data, better understand diseases, and develop new treatments.
People volunteer for clinical research for many reasons. Some are seeking a new treatment or experimental therapy that may be more effective than their current medical treatments. Others may want to take a more active role in their healthcare, gain access to investigational drugs, or receive health services like lab work, x-rays, or study drugs without health insurance.
For many, it’s also an opportunity to help advance medical research and improve health outcomes for future generations. By enrolling in clinical studies, participants contribute to the discovery of more effective therapies to improve the lives of people with the same disease.
There are many benefits to participating in a clinical trial. By joining a clinical research study, you can:
- Play an active role in your healthcare while helping researchers develop innovative treatments and medical devices that may benefit others.
- Gain early access to clinical research treatments before they’re available to the general public, potentially benefiting from new drugs that are being tested.
- Receive ongoing medical care without the cost of copays or deductibles, as all trial-related medical treatments are free for participants. Depending on the trial, the study drug or experimental treatment may be offered at no cost.
- You may be reimbursed for travel expenses or your time while participating in the research study.
Like most things in life, if there’s a potential benefit, there may also be some risks involved. However, the ARBDA Physicians & Clinical Research team carefully selects clinical trials that have the potential to impact you in a positive way.
Our criteria for selecting research studies are rigorous, prioritizing the safety of our patients above all else. Every clinical trial undergoes thorough review by an Institutional Review Board (IRB) and must meet stringent inclusion criteria to ensure the trial design is safe for those enrolled.
Before participating, all the possible risks and potential benefits of the study drug or treatment are fully explained to you in the informed consent document. You’re also free to withdraw from the research study at any time, for any reason, without impacting your future care.
