AN OPEN, NON-RANDOMISED PILOT STUDY OF ANTI-TNF-ALPHA THERAPY IN EARLY OR PROGRESSING HAM/TSP - HAM infliximab study

Active, not recruiting

• Conditions: HTLV-I associated myelopathy

• Registration Number: EUCTR2007-005554-23-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients will be eligible if they:
Are able to give informed consent
Are 16 years or older
Have ‘definite’ HTLV-I-associated myelopathy according to the criteria of Definite HAM/TSP” agreed in Belem 2003.
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.
Patients under follow up with new symptoms may be included immediately.

New patients presenting initially with symptoms already > 2 years would be eligible upon review if progression according to these criteria are met.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded if they have
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 infliximab, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified