The HAM Infliximab Study

NCT00823641 — Phase 2, Terminated, 3 participants, Imperial College London

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An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP

Registry	NCT00823641, acronym HAM06
Status	Terminated - Higher toxicity rate than observed in studies in Rheumatoid arthritis
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	3 (Actual)
Sponsor	Imperial College London (Other); collaborators: Medical Research Council
Conditions	HTLV-I-associated Myelopathy
Interventions	Infliximab (Drug)
Dates	start 2008-10-01, primary completion 2011-03-01, completion 2011-03-01, first posted 2009-01-15, last updated 2013-04-15
Locations	1 site in United Kingdom

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Infliximab	Experimental	Drug: Infliximab	Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study

Infliximab (Drug): Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study

+Outcome measures

Primary outcomes

Incidence of clinical failure [48 weeks]

Secondary outcomes

Change in timed 10m walk [12, 24, 48 and 72 weeks]
Clinical Safety [48 weeks]
HTLV-I viral load in CSF [12 weeks]
HTLV-I viral load in peripheral blood [12, 24, 48 and 72 weeks]
% CD4+ T- lymphocytes expressing CD25 [24, 48 and 72 hours]

+Eligibility

Sex: All, ages: 16 Years to any

Inclusion Criteria:

* 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 Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Imperial College Healthcare NHS Trust	London	United Kingdom

+Investigators

Graham P Taylor, MD, Principal investigator, Imperial College London