The HAM Infliximab Study

NCT00823641 | Terminated Phase 2 DMC

• 2 other identifiers: cro948EUDRACT: 2007-005554-23
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

HTLV-I-associated Myelopathy

Keywords

HAM/TSP; HTLV-I

Outcome Measures

Primary Outcomes (1)

• Incidence of clinical failure

  48 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

Infliximab

EXPERIMENTAL

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

Drug: Infliximab

Interventions

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

Infliximab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Paraparesis, Tropical Spastic

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; HTLV-I Infections; Deltaretrovirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Graham P Taylor, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Communicable Diseases

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: October 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

GB (1)