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Dr Joseph R Berger is the Principal Investigator for all the following research study
except for this one Title of Study: A randomized, multicenter, two arm, open label, 12
week phase IIIb study to evaluate the tolerability of Rebif (Interferon (IFN) beta-1a)
(New Formulation) and Betaseron (Interferon (IFN) beta-1b) in interferon-naïve
subjects with relapsing remitting multiple sclerosis; followed by a single-arm, 24 week,
Rebif® (New Formulation)-only safety extension. Dr Sidney Houff is the principal
Investigator.
PROTOCOL SUMMARY
Data Analysis Pending
Title of Study: Subtle Abnormalities in Normal Appearing White Matter of
Relapsing- Remitting MS Patients and the Response to Interferon-: A Pilot Study
Objectives:
1). Determine whether subtle abnormalities in the Blood Brain Barrier (BBB) can be
detected in otherwise Normal Appearing White Matter (NAWM) of the brains of patients
with newly diagnosed MS patients.
2). Determine whether magnetic resonance spectroscopy (MRS) detects alterations in
NAWM in newly diagnosed MS patients.
3).Determine whether interferon–beta (IFN-) can restore BBB integrity in these regions
after 6 and 24 weeks of therapy as indicated by normalization of contrast enhancements
4)Determine whether IFN- affects the MRS signature of White matter (WM) in MS
patients after 6 and 24 weeks of therapy.
Title of Study: JCV expression during treatment with MS disease modifying drugs
IRB Approved, awaiting GCRC, Set up Protocol meeting with GCRC and carryout
flow chart
During the course of treatment with natalizumab (Tysabri®), 2 patients with multiple
sclerosis developed progressive multifocal leukoencephalopathy (PML), a rapidly fatal
demyelinating disease of the brain secondary to JC virus (JCV), after a therapeutic
exposure of approximately 2 years.(Berger and Koralnik 2005; Kleinschmidt-DeMasters
and Tyler 2005; Langer-Gould, Atlas et al. 2005) Both patients were in the Sentinel trial
of combined Avonex® and Tysabri for the treatment of MS. These observations and that
of the occurrence of PML in a patient with Crohn's disease treated with natalizumab in
the ENACT trial(Van Assche, Van Ranst et al. 2005) resulted in additional studies of
patients exposed to natalizumab during clinical trials that suggested that the risk of
development of PML following exposure to this monoclonal antibody, an α4β1 integrin
inhibitor, is on the order of 1:1000.(Yousry, Major et al. 2006)
We propose that JCV reactivation in peripheral blood mononuclear cells will be unaltered
during the course of treatment with the currently available MS disease modifying drugs,
either the β-interferons or glatimir acetate.
Objectives:
There will be two primary objectives of this study:
A longitudinal study of treatment naïve MS patients to determine whether JCV
expression in peripheral blood mononuclear cells (PBMC) occurs following the institution
of β-interferon or other disease modifying therapy (DMD).
A cross-sectional study analysis of MS patients already on DMD to compare differences
in JCV expression in PBMC among the different treatment modalities and with respect to
a healthy control population.
Secondary objectives will include:
1). Determining if there are quantitative differences in the amount of JCV expression in
the PBMCs of the longitudinally studied patients.
2). Determining if there are quantitative differences in the amount of JCV expression in
the PBMCs of patients treated with different DMDs in the cross-sectional study.
3). Determining if there is a difference in the absolute number of patients expressing
JCV in the urine following the institution of treatment in the longitudinally studied
patients.
4). Determining if there is a difference in the absolute numbers of patients expressing
JCV in the urine among the patients treated with different DMDs in the cross-sectional
study.
5). Determining if there are quantitative differences in the amount of JCV expression in
the urine of the longitudinally studied patients.
Determining if there are quantitative differences in the amount of JCV expression in the
urine of patients treated with different DMDs in the cross-sectional study.
Title of Study: Double-blind, placebo-controlled, randomized, parallel-group Phase
II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the
safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a raterblind MRI follow-up over 12 weeks. IRB pending may need revisions and the
Sponsor set up a site initiation and may extend into the month of May.
Primary Objective
Compare the effects of 500 mg CDP323 twice daily on MS-related imaging parameters
in subjects with relapsing MS (RMS) with the effects seen under placebo treatment in
that population over a period of 24 weeks.
Exploratory Objectives
Compare CDP323's tolerability and safety in RMS subjects with placebo treatment in
that population over a period of 24 weeks;
Compare the effects of CDP323 on the occurrence of relapses in RMS subjects with the
effects seen under placebo treatment in that population over a period of 24 weeks;
Compare the effects of twice daily dosing of CDP323 vs. once daily dosing of
CDP323including the related time course of α4/VCAM-1 binding between the two dosing
regimen and placebo; Characterize the main pharmacokinetic parameters of CDP323
and its metabolites in subjects suffering from RMS.Assess potential withdrawal effects
after termination of treatment with CDP323.
Title of Study: A randomized, multicenter, two arm, open label, 12 week phase IIIb
study to evaluate the tolerability of Rebif (Interferon (IFN) beta-1a) (New
Formulation) and Betaseron (Interferon (IFN) beta-1b) in interferon-naïve
subjects with relapsing remitting multiple sclerosis; followed by a single-arm, 24
week, Rebif® (New Formulation)-only safety extension IRB pending for Revisions
have been submitted the Sponsor set up a site initiation and may extend into May
Objectives:
with relapsing remitting
multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores
from pre-injection to 30 minutes post therapy administration.
The primary objective of this study is to evaluate the tolerability of Rebif® and
Betaseron® in subjects with relapsing-remitting forms of MS (RRMS) comparing the
mean pain on VAS at 30 minutes post injection associated with assessment during and
after titration therapy over the 12 week comparative study period. The null hypothesizes
that there exists no difference in the mean change of the pain on VAS at 30 minutes post
injection from pre-injection across 21 full-dose of treatment (i.e., 7 weeks ofRebif and 6
weeks of Betaseron®) between the Rebif® groups vs. the Betaseron®group. The
alternative hypothesis is that there is a difference in the mean change of the pain on
VAS at 30 minutes post injection from pre-injection across 21 full-dose of treatment
between the Rebif® groups vs. the Betaseron® group.
Title of Study: H.P. Acthar® Gel Multiple Sclerosis Patient Experience Program
IRB Approved one patient consented and surveyed and called another awaiting
response.
There are a number of treatment alternatives available for multiple sclerosis (MS), each
of which has unique clinical benefits. This study is a survey to evaluate your
experiences with H.P. Acthar® Gel (repository corticotropin injection), indicated for the
treatment of acute exacerbations in patients with MS. Approximately 600 patients will be
included in the survey from about 120 practices within the continental United States.
Surveys will be used to develop quantitative summaries of patients’ experiences with
H.P. Acthar Gel and other medications for treatment of MS exacerbations.
The purpose of this research is to gather information using a survey to evaluate your
experiences with H.P. Acthar® Gel (repository corticotropin injection), indicated for the
treatment of acute exacerbations in patients with MS... Surveys will be used to develop
summaries of patients’ experiences with H.P. Acthar Gel and other medications for
treatment of MS exacerbations. The summaries will be communicated to members of
scientific and health care communities to aid future treatment selections for MS
exacerbations. The results of this study will be shared with the company providing
financial support for the study, the Food and Drug Administration and other federal
agencies, if required.
Title of Study: A Multinational, Multicenter, Randomized, Parallel-Group, DoubleBlinded Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer
Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml
Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing
Remitting (R-R) Multiple Sclerosis TEVA CLOSED
Approximately 1,000 patients with relapsing remitting M.S. at approximately 160 study
centers worldwide will participate in this study. Approximately 350 patients at
approximately 40 centers in the U.S. will participate. For the first twelve months of the
study, half of the patients in the study will receive glatiramer acetate 20 mg and the other
half will receive glatiramer acetate 40 mg. For the second half of the study (visit months
12 through 24), all patients in the study will receive glatiramer acetate 40 mg.
Title of Study: International, randomized, multicenter, phase III study in patients
with relapsing-remitting multiple sclerosis comparing over a treatment period of
104 weeks: BEYOND Closed
In this study, two different medications for the treatment of MS will be compared,
interferon-1b and Copaxone®. Both of them have been shown to be safe and effective
in treating MS, and both of them are to be given subcutaneously (injected under the
skin). The interferon-1b treatment will be administered in two different dosages, the
approved standard dose (250 micrograms every other day) and a higher dose
(500 micrograms every other day); Copaxone® will be administered in its approved dose
of 20 mg every day. Interferon-1b 250 micrograms and Copaxone® are approved
therapies in MS treatment whereas interferon-1b 500 micrograms is experimental and
will be tested in this study. This study will try to answer two (2) questions: Is treatment
with interferon-1b 500 micrograms safe, tolerable and more effective than treatment with
interferon-1b 250 micrograms?
There is evidence from other studies that interferon-1b is more efficacious when
increasing the dose. On the other hand, an increased dose may lead to more side
effects which might also be more severe. This study will find out whether a higher
efficacy can be shown when administering the higher dose and whether this effect will
justify possible increases in side effects. This relationship is called risk-benefit ratio; it
will be assessed for both doses of interferon-1b.
Is treatment with interferon-1b safe, tolerable and more efficacious than treatment with
Copaxone® 20 mg?
B) A Multicenter, Randomized, Blinded, Parallel-Group Study of AVONEX
Compared with AVONEX in Combination with Oral Methotrexate, Intravenous
Methylprednisolone, or Both in Subjects with Relapsing-Remitting Multiple
Sclerosis Who Have Breakthrough Disease on Avonex Monotherapy.
(pharmaceutical company funded – Biogen) CLOSED
Currently, Avonex at a dose of 30 micrograms by weekly injection in the muscle is
approved as treatment for relapsing-remitting multiple sclerosis (MS). The purpose of
this study was to determine whether adding weekly oral chemotherapy drug (usually
given to patients with cancer or immunologic disorders, such as rheumatoid arthritis)
methotrexate (MTX), every other month intravenous methylprednisolone (IVMP), or both
to Avonex is safe and beneficial for patients with relapsing-remitting MS who have had
acute relapses (attacks) or enhancing MRI lesions (active spots) while on Avonex
therapy alone. MTX and IVMP are anti-inflammatory drugs that decrease the activity of
the immune system. Previous clinical experience and small preliminary experimental
studies suggest that they are safe and may be of benefit in MS, both alone and in
combination with Avonex. Approximately 900 patients were enrolled in the study at
sites in the U.S. Patients participated in the study for up to 26 months.
The subjects continued standard Avonex therapy and were assigned by chance to one
of the following groups:
Group 1 – received four placebo pills (an inactive substance that looks the same as
MTX) once per week.
Group 2 – received four MTX pills (20 mg) once per week.
Group 3 – received IVMP 1000 mg on three consecutive days every other month plus
four placebo pills per week.
Group 4 – received IVMP 1000 mg on three consecutive days every other month plus
four MTX pills (20 mg) once per week