Status:
TERMINATED
The HAM Infliximab Study
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Medical Research Council
Conditions:
HTLV-I-associated Myelopathy
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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 e...
Eligibility Criteria
Inclusion
- Are able to give informed consent
- Are 16 years or older
- Have 'definite' HAM/TSP according to the criteria of "Definite HAM/TSP" agreed in Belem 200361
- Have early or progressing disease as defined here:
- "Early HAM/TSP": Patients must have motor disability (minimum of stiffness or weakness) for less than 2 years. (Bladder symptoms if the original and only presenting symptoms as assessed by history are not included)
- "Progressing HAM/TSP"
- New or worsening motor symptoms in a patient with definite HAM of \> 2 years duration within the last 3 months
Exclusion
- Hepatitis B or hepatitis C infection
- HIV infection
- Overt sepsis, abscesses or opportunistic infections
- Active TB (untreated or on treatment)
- Strongyloides stercoralis (untreated)
- Known hypersensitivity to inflixmab, other murine proteins or to any of the excipients
- Malignancy
- Moderate or severe heart failure (NYHA class III/IV)
- Pregnancy or breastfeeding
- Unhealed surgical wounds
- Planned impending surgery - treatment would be withheld for 2-4 weeks prior to major surgery and started/restarted post-operatively if no evidence of infection and wound healing is satisfactory
- Current immunosuppressive or immunomodulatory therapy
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00823641
Start Date
October 1 2008
End Date
March 1 2011
Last Update
April 15 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1PG