Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular
 interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in
 patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease
 activity.
Eligible individuals were evaluated monthly for 3 months while taking intramuscular
 interferon beta-1a, 30 micrograms weekly, then monthly for 4 months while receiving
 intramuscular interferon beta-1a, 30 micrograms and oral doxycycline, 100 mg daily.
Inclusion Criteria:

 -  age 18-55

 -  Relapsing-Remitting Multiple Sclerosis (RRMS)

 -  Avonex therapy for 6 months prior continuous

 -  annualized relapse rate >2 during Avonex therapy

 -  most recent relapse within 60 days of baseline

 -  entry Expanded Disability Status Scale (EDSS) 1.5-4.5

 -  one or more gadolinium (Gd+) MRI lesions on a baseline MRI

 -  no history of immune modulator or immunosuppressant therapy used in combination with
 Avonex (other then GSC administer for clinical relapses)

 -  not participating in any other study of ms therapeutics

 -  Serum neutralizing antibodies (NABs) titer to Avonex <20

 Exclusion Criteria:

 -  Medical or Psychiatric conditions that will affect patients ability to provide
 informed consent

 -  inability to undergo MRI

 -  clinically serious medical conditions or significantly abnormal labs

 -  no use of these medications or procedures within six months prior to study:

 *monoclonal antibodies,total lymphoid radiation,systemic steroids,cytotoxic or
 immunosuppressive medications such as mitoxantrone or cyclophosphamide or any other
 investigational drugs

 -  Interferon neutralizing antibody titers >20

 -  no breast feeding or pregnant

 -  no patients with any systemic illness,psychiatric condition or other disorder that
 would concern safety of patient to complete procedures of protocol

 -  abnormal blood test

 -  clinically significant abnormality on chest x-ray (CXR)