The HAM Infliximab Study

HTLV-I-associated Myelopathy Clinical Trial

— HAM06  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00823641
• Other study ID #: cro948
• Secondary ID: EUDRACT: 2007-00
• Status: Terminated
• Phase: Phase 2
• First received: January 14, 2009
• Last updated: April 12, 2013
• Start date: October 2008
• Est. completion date: March 2011

Study information

• Verified date: April 2013
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HTLV-I-associated Myelopathy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinical failure		48 weeks	No
Secondary	Change in timed 10m walk		12, 24, 48 and 72 weeks	No
Secondary	Clinical Safety		48 weeks	Yes
Secondary	HTLV-I viral load in CSF		12 weeks	No
Secondary	HTLV-I viral load in peripheral blood		12, 24, 48 and 72 weeks	No
Secondary	% CD4+ T- lymphocytes expressing CD25		24, 48 and 72 hours	No