HTLV-I associated myelopathy
Conditions
Interventions
Trade Name: Remicade 100mg powder for concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible if they: Are able to give informed consent Are 16 years or older Have ‘definite’ HTLV-I-associated myelopathy according to the criteria of “Definite HAM/TSP” agreed in Belem 2003. 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. Patients under follow up with new symptoms may be included immediately. New patients presenting initially with symptoms already > 2 years would be eligible upon review if progression according to these criteria are met. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have 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 infliximab, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine in an open, pilot, proof of concept study whether infliximab improves, compared with baseline the clinical measures of patients with ‘early’ or ‘progressing’ definite HTLV-I-associated myelopathy ;Secondary Objective: To determine in patients with HTLV-I-associated myelopathy the safety of infliximab the effect of infliximab on viral load and expression the effect of infliximab on markers of activation and proliferation To explore the mechanism of pathogenesis of HTLV-I-associated myelopathy by understanding the effect of infliximab on the severity and progression of HTLV-I-associated myelopathy. ;Primary end point(s): The primary endpoints will be: 1. Incidence of clinical failure at 48 weeks. 2. Time from week 0 to clinical failure (Kaplan-Meier) Clinical Failure will be defined as any one of the following three: 1. Lack of any objective improvement: timed walk or spasticity or bladder function or pain by 24 weeks of therapy, compared to baseline (average of week -4 and week 0). Definition of improvement - a. Disability decreased by 3 points on Instituto de Pesquisa Clinica Evandro Chagas (IPEC) scale b. >30% improvement in timed walk c. Visual analogue Pain score reduced by > 2 points on 0 - 10 scale d. Bladder function – sustained reduction in frequency (= 1), nocturia (= 1) or residual volume (= 10%) e. Any reduction in spasticity as measured by a positive change in the Modified Ashworth scale in any functional muscle group. 2. A three-point deterioration in IPEC scale measurements, on 2 consecutive separate time points, compared with the baseline (average of week-4 and week 0) at any time. 3. 30% deterioration of timed walk on 2 consecutive separate time points, compared with baseline (average of week -4 and week 0) at any time. | — |
Countries
United Kingdom
Outcome results
None listed