RMC

Clinical Research

A clinical research study is a medical investigation designed to answer specific questions about potential new medications or existing medications. These questions can include how safe and effective a particular medication is, or what is the best dose of the medication. All new medications must undergo thorough testing in clinical research studies before they can be prescribed by doctors. Without clinical research studies, no new medications could be developed and few medical advances would be made. It cannot be promised that the study will help you but in the future the information we get from this study may help improve the future treatment of people with the same condition.

Your participation in a research study is strictly voluntary, meaning that you may or may not choose to take part. It is up to you to decide whether to take part or not. Even if you do decide to take part, you are free to discontinue treatment or withdraw consent from the study at any time without giving a reason. This will not affect your future medical care in any way. To help you decide, you should understand the study and what it will involve for you. To make an informed decision to take part you should know the purpose of the study, the procedures, the benefits and risks of the study, the discomforts and the precautions taken. This process is called “informed consent.”

You must not be pregnant or breastfeeding, and you should not become pregnant or breastfeed while you are taking the study treatments. If you are a women of child bearing potential, you must use a highly effective method of birth control to avoid pregnancy during the study. Please talk to your study doctor about effective methods of birth control. Sexual partner(s) of a male study participant can be exposed to the study drug because small amounts of investigational compounds may be present in seminal fluids. For this reason you must communicate your participation in the clinical trial to any sexual partner(s) you may have.

Open Studies

ALLERGIC RHINITIS

The immune system of our body protects us against foreign substances like bacteria or viruses or allergens. In some people, the immune system may over-react to the presence of an allergen (such as grass or tree pollen). These people develop allergic symptoms like hay fever (allergic rhinitis) or asthma. Immunotherapy consists of the repeated administration of an allergen to people with allergies to induce a tolerance of the immune system to that allergen. Over time, immunotherapy may reduce the allergic reaction to that particular allergen.

The purpose of protocol SL75.14 study is to assess the efficacy (the ability to improve symptoms) and safety of investigational tablets placed sublingually (under the tongue) once a day. The word “investigational” means that the drug is not yet approved by the United States Food and Drug Administration (U.S. FDA), and is therefore not yet commercially available in the U.S. Rather it is still being evaluated in medical research studies. The tablet used in this study is an immunotherapy tablet for allergic rhinitis due to house dust mites (HDM). It contains HDM allergen extracts. People in the study will be taking either the active (HDM extracts tablet) or the placebo (no active ingredient) tablet.

Approximately 1,740 adults and adolescents will participate in this study. About 870 people will take the HDM extracts tablets and 870 will take the placebo (dummy). The study will be conducted in approximately 150 to 190 medical centers in the United States, Canada, Israel, Russia, and several European countries.

RHEUMATOID ARTHRITIS

Rheumatoid Arthritis is a long-term disease in which the body’s immune system reacts against some of its own tissue and produces antibodies (proteins within the body) to attack itself. In RA, the immune system mainly targets the joints, causing inflammation, pain and swelling.

The CREDO-2 and CREDO-3 clinical research studies are a Phase 3 study. This means that both healthy volunteers and people with rheumatoid arthritis (RA) have already taken the study drug. However, more needs to be known about the study drug before it can be approved for use by doctors to treat RA. These studies will find out how well the study drug works by comparing the study drug with a placebo. A placebo looks the same as the study drug, but contains no active ingredients. Placebos are used in clinical research studies to ensure that any effects seen in patients taking part in the study are a result of the study drug itself.

CREDO-2

If you have been diagnosed with RA and you have also been taking a stable dose of medication called MTX for the treatment of RA, but it is not working well for you – This study will look at how safe and effective the study drug is in patients with RA who are already receiving, but not fully responding to an existing medication called methotrexate (MTX).

The study drug, adalimumab and placebo are all administered by a member of the study team as an injection under the skin of your thighs or abdomen (stomach). This study will find out how well the study drug works by comparing the study drug with a medication called adalimumab (Humira®), and a placebo. Adalimumab is a drug that is already approved for use by doctors to treat RA. It is approved in several regions, including the U.S. and E.U.

The results of previous studies using the study drug have shown that the study drug is more effective than a placebo in reducing the symptoms of RA.

Approximately 1575 patients in up to 235 study centers from across Russia, the U.S., the E.U., Asia, and Latin America will take part in this study. Taking part in this study is entirely voluntary (your choice) and your participation will be kept private.

CREDO-3

If you have been diagnosed with RA and you have also been taking MTX for at least 12 weeks with a stable dose for at least 6 weeks. You have also been taking a TNFi medication for at least 12 weeks, for the treatment of RA, but it is not working well for you – This study will look at how safe and effective the study drug is in patients with RA who are already receiving, but not fully responding to, an existing medication called a tumor necrosis factor alpha inhibitor (TNFi).

The study drug and placebo will be administered by a member of the study team as an injection under the skin of your thighs or abdomen (stomach). The study drug is called olokizumab and is an antibody that has been designed for use as a medication to treat RA. It is a manufactured antibody that blocks a substance called interleukin 6 (IL-6). IL-6 is a protein made by the white blood cells in your body and may be involved in the inflammation seen in RA. By blocking IL-6, the study drug stops it from working, thereby helping to reduce the symptoms of RA.

The results of previous studies using the study drug have shown that the study drug is more effective than a placebo in reducing the symptoms of RA.

Approximately 350 patients in up to 180 study centers from across Russia, Turkey, the United States (U.S.), the European Union (E.U.), Asia and Latin America will take part in this study. Taking part in this study is entirely voluntary (your choice) and your participation will be kept private.

SJOGRENS

The purpose of this study is to see if abatacept is better than placebo (inactive substance) for the treatment of Sjögren’s syndrome. Therapies to improve symptoms of dry eyes and dry mouth are available. There are no alternative therapies that are currently approved for treatment of the symptoms of Sjögren’s syndrome other than dry eyes and dry mouth.

About 172 patients from approximately 13 countries are expected to participate in this study, with approximately 35 participants/patients of them in the United States and Puerto Rico.