Title: Myxovirus- Resistant Protein A as a Measure of Clinical Efficacy of Interferon- Beta Treatment in Patients with Multiple Sclerosis (MARBLE)
Purpose: Assessing a test for a protein in blood which may help doctors see if your MS treatment is working.
Main Eligibility Requirements:
• be 18-65 years of age;
• be positively diagnosed with MS;
• must have been on Betaseron or Rebif for at least 1 year
You will be compensated up to $40 for your time. Your participation will last about 8 days.
================================================
Title : A Phase III, randomized, double-blind, placebo-controlled, multicenter
clinical trial of oral cladribine in subjects with a first clinical event at high risk of
converting to multiple sclerosis.
Purpose: To study the effectiveness, safety, and tolerability of high-dose and low-dose oral cladribine (cladribine tablets) versus placebo (tablets containing no active
medication) in the treatment of clinically isolated syndrome.
Main Eligibility Requirements:
1. Between 18 and 55 years old.
2. Has experienced a single, first clinical event suggestive of MS within 75 days.
3. Has no medical history or evidence of latent tuberculosis infection or active
tubercular disease.
==================================================
Title: A combination trial of Copaxone plus estriol in relapsing-remitting multiple sclerosis.
Purpose: to determine if the use of oral estriol (8mg/day) in combination with Copaxone injections (20mg/day) is an effective treatment for multiple sclerosis.
Main Eligibility Requirements:
-Females age 18 to 50.
-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 relapse within 30 days before day of trial enrollment.
-Cannot smoke at any time during the screening process or for the duration of the study.
-If post-menopausal, must be taking hormone replacement therapy or have been
on hormone replacement therapy within 1 year.
Contact information:
UCLA; Dr. Barbara Giesser
Coordinator: Mike Montag
310-794-4020
Washington University, St. Louis; Dr. Anne Cross
Coordinator: Debbie Kemp
314-362-3839
UMDNJ, New Brunswick; Dr. Suhayl Dhib-Jalbut
Coordinator: Yaritza Rosario
732-235-7099
OSU, Columbus; Dr. M. Racke
Coordinator: Lisa Hafer
614-293-7877
University of Chicago; Dr. Anthony Reder
Coordinator: Mildred Valentine
773-702-9812
University of Utah, Salt Lake; Dr. John Rose
Coordinator: Julia Klein
801-582-1565 X2014
U. of Texas Southwestern, Dallas; Dr. A. Courtney
Coordinator: Gina Remington
214-645-0560
Johns Hopkins U., Baltimore; Dr. John Ratchford
Coordinator: Stephanie Syc
410-502-2488
University of Colorado, Aurora; Dr. John Corboy
Coordinator: Caitlin Pattamasaevi
303-724-8905
U. of New Mexico, Albuquerque; Dr. Corey Ford
Coordinator: Lori Bachert
505-272-8905
U. of Pennsylvania, Philadelphia; Dr. Dina Jacobs
Coordinator: Vanessa Zimmerman
215-349-5162
Dartmouth Med. Sch., Lebanon, NH; Dr. L. Kasper
Coordinator: Kathleen Ryan
603-653-9919
U. of Kansas, Kansas City; Dr. Sharon Lynch
Coordinator: Kelly Dickerson
913-588-0080
U. of Minnesota, Minneapolis; Dr. Gareth Parry
Coordinator: Susan Rolandelli
612-624-5978
Columbia University, New York; Dr. Mark Tullman
Coordinator: Pat Mead-D'Alisera
212-342-8647
Mayo Clinic Arizona, Scottsdale; Dr. D. Wingerchuk
Coordinator: Irene Galasky
480-301-6104
=================================================
The following study does not have a site location at the Rocky Mountain MS Center at Anschutz Medical Campus
=================================================
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 e-mail address is being protected from spambots. You need JavaScript enabled to view it
=================================================
