Clinical Trial: The HAM Infliximab Study
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP
Brief Summary:
An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with 'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible patients will have either early disease (of less than 2 years duration) or progressive disease (with observed clinical deterioration during the preceding 3 months.
Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be followed up for a further 24 weeks. Study assessments will be clinical, virological, immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72. CSF will be examined, on therapy, at week 12.
Detailed Summary:
Sponsor: Imperial College London
Current Primary Outcome: Incidence of clinical failure [ Time Frame: 48 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in timed 10m walk [ Time Frame: 12, 24, 48 and 72 weeks ]
- Clinical Safety [ Time Frame: 48 weeks ]
- HTLV-I viral load in CSF [ Time Frame: 12 weeks ]
- HTLV-I viral load in peripheral blood [ Time Frame: 12, 24, 48 and 72 weeks ]
- % CD4+ T- lymphocytes expressing CD25 [ Time Frame: 24, 48 and 72 hours ]
Original Secondary Outcome: Same as current
Information By: Imperial College London
Dates:
Date Received: January 14, 2009
Date Started: October 2008
Date Completion:
Last Updated: April 12, 2013
Last Verified: April 2013
