The HAM Infliximab Study (HAM06)

This study has been terminated.
(Higher toxicity rate than observed in studies in Rheumatoid arthritis)
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Graham Taylor, Imperial College London
ClinicalTrials.gov Identifier:
NCT00823641
First received: January 14, 2009
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
HTLV-I-associated Myelopathy
Drug: Infliximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Incidence of clinical failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in timed 10m walk [ Time Frame: 12, 24, 48 and 72 weeks ] [ Designated as safety issue: No ]
  • Clinical Safety [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • HTLV-I viral load in CSF [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HTLV-I viral load in peripheral blood [ Time Frame: 12, 24, 48 and 72 weeks ] [ Designated as safety issue: No ]
  • % CD4+ T- lymphocytes expressing CD25 [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 14, 2009
Last Updated: April 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Paraparesis, Tropical Spastic
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Central Nervous System Infections
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014