The HAM Infliximab Study

NCT ID: NCT00823641

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Graham Taylor

Reader in Communicable Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Graham P Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

EUDRACT: 2007-005554-23

Identifier Type: -

Identifier Source: secondary_id

cro948

Identifier Type: -

Identifier Source: org_study_id