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The HAM Infliximab Study (HAM06)

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ClinicalTrials.gov Identifier: NCT00823641
Recruitment Status : Terminated (Higher toxicity rate than observed in studies in Rheumatoid arthritis)
First Posted : January 15, 2009
Last Update Posted : April 15, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
HTLV-I-associated Myelopathy Drug: Infliximab Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP
Study Start Date : October 2008
Primary Completion Date : March 2011
Study Completion Date : March 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: 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
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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of clinical failure [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Change in timed 10m walk [ Time Frame: 12, 24, 48 and 72 weeks ]
  2. Clinical Safety [ Time Frame: 48 weeks ]
  3. HTLV-I viral load in CSF [ Time Frame: 12 weeks ]
  4. HTLV-I viral load in peripheral blood [ Time Frame: 12, 24, 48 and 72 weeks ]
  5. % CD4+ T- lymphocytes expressing CD25 [ Time Frame: 24, 48 and 72 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823641


Locations
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
Medical Research Council
Investigators
Principal Investigator: Graham P Taylor, MD Imperial College London
More Information

Responsible Party: Graham Taylor, Reader in Communicable Diseases, Imperial College London
ClinicalTrials.gov Identifier: NCT00823641     History of Changes
Other Study ID Numbers: cro948
EUDRACT: 2007-005554-23
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by Graham Taylor, Imperial College London:
HAM/TSP
HTLV-I

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents