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Clinical Research & Trials
If you would like be notified when new clinical trials are added, please click HERE.
Please note that the studies listed below are being conducted at the Rocky Mountain MS Center, University of Colorado Denver Anschutz Medical Campus. You will be required to come to the study site for visits. Many of the studies are conducted at various sites around the United States and therefore if you do not reside in the Rocky Mountain Region, there may be a site in or near your area that would be more convenient. We will do our best to provide you with this information if available. You may be able to find this information using http://www.clinicaltrials.gov as well.
If you are interested in any of the studies listed below please call 303-724-4644 and provide your name, a phone number where you can be reached and the best time to reach you. Please allow 5-7 business days for a response.
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TRIALS
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Title: A phase II, double blinded, placebo controlled, randomized study comparing rituximab induction therapy followed by glatiramer acetate therapy to glatiramer acetate monotherapy in patients with relapsing forms of multiple sclerosis.
Purpose: To determine if induction through the use of two infusions of Rituxan®(1000mg/infusion) followed bydaily Copaxone® injections (20mg/day) is more effective than a monotherapy of Copaxone® injections (20mg/day).
Main Eligibility Requirements:
- 18 to 55 years of age;
- Diagnosis of active relapsing remitting multiple sclerosis as defined by either:
- At least two clearly identified relapses within 24 months prior to study entry, OR
- At least one clearly identified relapse within 24 months prior to study entry AND have a history of at least one gadolinium enhancing lesion on a T1 brain or cord MRI
- No treatment with interferon β (Avonex®, Rebif®, Extavia®, Betaseron®) or fingolimod (Gilenya®) within 3 months of randomization;
- No treatment with natalizumab (Tysabri®) within 14 days of randomization;
- No history of clinically significant cardiac arrhythmias, angina or any other clinically significant cardiac abnormalities;
- No history of clinically significant chronic disease of the immune system or a known immunodeficiency syndrome (HIV) other than MS;
- Negative for any past or current evidence of hepatitis B and/or C infection;
- No history or presence of malignancy (except basal cell carcinoma).
Contact information:
Mimi Burch at 303-724-6632 or This email address is being protected from spambots. You need JavaScript enabled to view it.
Dr. Timothy Vollmer
COMIRB# 10-1143 Approved 01/26/2012
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Title: A Longitudinal, Case-Control Study to Collect Medical and Epidemiological Data and Blood Samples for Research Into the Causes of Multiple Sclerosis and Selected Demyelinating Diseases (ACP)Purpose: To establish a collection of blood samples and associated data from people whom have experienced at least one Central Nervous System (CNS) demyelinating event characteristic of the following syndromes or diseases: Multiple Sclerosis (MS), Transverse Myelitis (TM), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica (NMO) or Optic Neuritis (ON). We will also collect blood samples from their blood relatives (those who have and have not experienced a CNS demyelinating event), and unrelated subjects who have not experienced any central nervous system event. The samples and data will be made available to research scientists who are involved in the study of MS, TM, ADEM, NMO, and/or ON, and in particular, studies involved in determining the causes of these syndromes/diseases.
Main Eligibility Requirements:
- Individuals at least 18 years old
- Individuals with at least one CNS demyelinating event lasting at least 24 hours and not acute in onset
- Willing and able to provide up to 110 ml blood via venipuncture
The following study does not have a research location at the Rocky Mountain MS Center at Anschutz Medical Campus
Title: DELIVER Study. A study to evaluate delivery of Natalizumab (Tysabri®)
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 nearby.
Study Objective:
The objective of the study is to determine if Natalizumab can be given by subcutaneous (SC) injection (under the skin). This will be accomplished through laboratory blood work, clinical assessments, and MRI scans.
Study Description:
The study is sponsored by Biogen Idec. Neurologist Dr. Ronald Murray will oversee all study activities at IMMUNOe Health Centers.
New participants will be assigned to either Group D or Group E:
Group A IV Group B SC Group C IM Group D SC Group E IV Group F Reference
Participation in Groups D or E will last approximately 8 months and will include 22 office visits and 8 MRIs.
Eligibility will be assessed at the first visit (Screening Visit).
If qualified, the patient will receive either an infusion or injection of Natalizumab (Baseline visit)
Following the Baseline treatment, patients will return for 10 blood draws.
The blood draws will occur daily for the next four days post treatment (treatment is usually on Mon and blood draws are sch. for Tues, Wed, Thurs, Fri).
The next 6 blood draws will occur weekly for the following 2 months after treatment.
After 2 months, patients will resume a monthly schedule of treatment visits for the next 6 months.
Patient Profile (for Groups D and E):
• Male and Females between 18 to 65
• Diagnosed with Relapsing Forms MS (No SPMS or PPMS patients)
• Must be Tysabri Naïve
• EDSS between 0 and 6.5 (wheel chair bound = 7 and these patients are excluded)
• No other conflicting medical condition which would jeopardize the patient or study data
• Able to undergo an MRI (lasting an hour)
Costs:
There is no cost to participate. You may be reimbursed for any reasonable travel costs as a result of your participation in this study.
Information: contact Lauren Friedman at 303-224-4671 or This email address is being protected from spambots. You need JavaScript enabled to view it.
For more information on various clinical trials throughout the United States please visit:
www.clinicaltrials.gov
Receive monthly updates on current clinical trials via email.
