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The HAM Infliximab Study (HAM06)

Primary Purpose

HTLV-I-associated Myelopathy

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Infliximab
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HTLV-I-associated Myelopathy focused on measuring HAM/TSP, HTLV-I

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infliximab

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of clinical failure

Secondary Outcome Measures

Change in timed 10m walk
Clinical Safety
HTLV-I viral load in CSF
HTLV-I viral load in peripheral blood
% CD4+ T- lymphocytes expressing CD25

Full Information

First Posted
January 14, 2009
Last Updated
April 12, 2013
Sponsor
Imperial College London
Collaborators
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00823641
Brief Title
The HAM Infliximab Study
Acronym
HAM06
Official Title
An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
Higher toxicity rate than observed in studies in Rheumatoid arthritis
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imperial College London
Collaborators
Medical Research Council

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HTLV-I-associated Myelopathy
Keywords
HAM/TSP, HTLV-I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infliximab
Arm Type
Experimental
Arm Description
Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study
Primary Outcome Measure Information:
Title
Incidence of clinical failure
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Change in timed 10m walk
Time Frame
12, 24, 48 and 72 weeks
Title
Clinical Safety
Time Frame
48 weeks
Title
HTLV-I viral load in CSF
Time Frame
12 weeks
Title
HTLV-I viral load in peripheral blood
Time Frame
12, 24, 48 and 72 weeks
Title
% CD4+ T- lymphocytes expressing CD25
Time Frame
24, 48 and 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham P Taylor, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1PG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The HAM Infliximab Study

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