HTLV-I-associated MyelopathyPhase 2HAM06NCT00823641
The HAM Infliximab Study
A Phase 2 study testing Infliximab in people with HTLV-I-associated Myelopathy, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HTLV-I-associated Myelopathy
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2008to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1PG
About this study
Official title: An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP
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
- Being tested
- Infliximab
- Keywords
- HAM/TSP, HTLV-I
- Medical subject headings
- Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical failure
Measured: 48 weeks
Secondary outcomes (5)
Change in timed 10m walk
Measured: 12, 24, 48 and 72 weeks
Clinical Safety
Measured: 48 weeks
HTLV-I viral load in CSF
Measured: 12 weeks
HTLV-I viral load in peripheral blood
Measured: 12, 24, 48 and 72 weeks
% CD4+ T- lymphocytes expressing CD25
Measured: 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Higher toxicity rate than observed in studies in Rheumatoid arthritis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HTLV-I-associated MyelopathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Graham Taylor, Imperial College London
- Investigators
- Graham P Taylor, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823641
- Sponsor's protocol ID
- cro948
- Other IDs
- EUDRACT: 2007-005554-23
- Acronym
- HAM06
- Status last verified
- Apr 2013
- First submitted
- 14 Jan 2009
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP
- ClinicalTrials.gov ID
- NCT00823641
- Acronym / sponsor ID
- HAM06 / cro948
- Conditions
- HTLV-I-associated Myelopathy
- Keywords
- HAM/TSP, HTLV-I
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Higher toxicity rate than observed in studies in Rheumatoid arthritis
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Experimental | Drug: InfliximabInfliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- "Progressing HAM/TSP"
Key exclusion criteria (12 listed)
- Hepatitis B or hepatitis C infection
- HIV infection
- Overt sepsis, abscesses or opportunistic infections
- Active TB (untreated or on treatment)
- Strongyloides stercoralis (untreated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabInfliximab 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 |
Primary outcome
Incidence of clinical failure
Time frame: 48 weeks
5 secondary outcomes
Change in timed 10m walk
Time frame: 12, 24, 48 and 72 weeks
Clinical Safety
Time frame: 48 weeks
HTLV-I viral load in CSF
Time frame: 12 weeks
HTLV-I viral load in peripheral blood
Time frame: 12, 24, 48 and 72 weeks
% CD4+ T- lymphocytes expressing CD25
Time frame: 24, 48 and 72 hours
Results and safety
The study was stopped early (reason given: Higher toxicity rate than observed in studies in Rheumatoid arthritis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
Related trials for HTLV-I-associated Myelopathy
RecruitingPhase 1/2
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
HAM/TSP
RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
HTLV-1 Infection, HTLV I Associated Myelopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham P Taylor, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infliximab in people with HTLV-I-associated Myelopathy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Higher toxicity rate than observed in studies in Rheumatoid arthritis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical failure (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.