Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis

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)