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Principal Investigator: Isaac Melamed Location: Centennial, CO Description: There is currently no therapy for Relapsing Remitting Multiple Sclerosis (RRMS) that is easy to administer and does not involve painful injections. Become part of a study to pursue an oral treatment for RRMS. Qualifications Include: The study involves 10-12 office visits over a 2 year period. Patients will receive at no cost: MRIs, Physical Exams, Neurological Exams, Investigational medicine, care from an experienced medical team, and up to $550 dollars compensation for time and travel. For further information feel free to contact the study coordinator, Lauren Friedman, at 303-224-4700 or by email Lfriedman@1sthealthcenters.com Click here to volunteer for a research study. A brief introduction to the DELIVER study Study Objective: The purpose of this investigational study is to look at two other ways of using natalizumab: subcutaneously (SC) injection (under the skin) and intramuscularly (IM) injection (into the muscle). A range of doses will be administered to better understand the safety of giving natalizumab these ways, as well as, how long natalizumab stays in the body and the effects it has on the body. SC and IM injections would reduce the amount of time required for treatment and eliminate the need for patients to go to an infusion center. This investigational study will help to determine if it may be possible to use these ways of natalizumab administration in the future. Study Description: Neurologist, Dr. Ronald Murray, will oversee all study activities. The study will last approximately 1 year and 8 months and is sponsored by Biogen Idec, Inc. Patients are assigned to receive natalizumab through an intravenous (IV) infusion, subcutaneous injection, intramuscular injections, or a reference group.In the first two months, all patients will attend 1 screening visit (over a minimum of five days) and 1 office visit to determine treatment group assignments (baseline visit). Patients assigned to one of the five natalizumab groups will receive an initial dose of medication at the baseline visit and will return for blood draw visits throughout 8 weeks (4 in 1st week and 7 in the following 7 weeks). At the beginning of the third month, patients will return once a month for their assigned dosing. Patients in the reference group will receive standard treatment of care (e.g. Copaxone®, Rebif®, Avonex®) and will begin monthly natalizumab dosing at month 8. Study Rationale: While other Multiple Sclerosis medications can be administered at home, natalizumab is given through IV at infusion centers. This can be costly and inconvenient to patients, especially if there is not an infusion center near by. In addition, as there is a lack of approved treatments for Secondary Progressive Multiple Sclerosis (“SPMS”), one of the purposes of this study is to find out if natalizumab is safe and well-tolerated in patients with SPMS when it is administered for several months. Qualifications Include: Compensation: Natalizumab will be supplied by Biogen Idec while you participate in this study. You will be reimbursed for any reasonable travel costs incurred as a result of your participation in this study. For further information contact the study coordinator, Lauren Friedman, at 303-224-4700 or by email Lfriedman@1sthealthcenters.com Click here to volunteer for a research study.
Study Objective: Tysabri is a monoclonal antibody that has been approved for the treatment of relapsing forms of MS. Tysabri is designed to hamper the movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier,” and into the brain and spinal cord. The drug inhibits this movement by attaching to alpha 4-integrin, a protein on the surface of immune T-cells that normally enables them to adhere to and then pass through the blood-brain barrier. Study Description: The study is being conducted at several sites across the United States, including Dr. Ronald Murray in the south Denver Metro area. Patients are assigned to receive either TYSABRI® in conjugation with two vaccinations over an 8 month period or two vaccinations alone (without treatment) over a 2 month period. The two vaccines include, the Tetanus Diphtheria Vaccine (common in the general population, this vaccine will be used to assess recall response) and IMMUCOTHEL also called keyhole limpet hemocyanin (uncommon in the general population, this vaccine will be used to assess the primary humoral response). Qualifications Include: Compensation: Participants will receive study drug as well as study related health care from an experienced medical team at no cost. Compensation for time and travel will also be given. For further information contact the study coordinator, Lauren Friedman, at 303-224-4671 or by email Lfriedman@1sthealthcenters.com |
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