None listed
Conditions
Brief summary
The STRIKE trial is a single-centre, investigator-initiated pilot study assessing the efficacy, feasibility and safety of infliximab in patients with artificial stone-associated complicated silicosis. Participants will receive 5 mg/kg intravenous infliximab at weeks 0, 2, and 6, followed by maintenance infusions every 6 weeks until week 24. The primary outcome is a composite measure of changes in inflammatory activity using PET scan, lung function parameters (FEV1, FVC, DLCO), and health-related quality of life. Secondary outcomes are adverse event rates, serum biomarkers, and HRCT findings. The trial is being conducted at Alfred Hospital and is sponsored by Alfred Health.
Interventions
The STRIKE trial is a single-centre, investigator-initiated pilot study assessing the efficacy of infliximab in patients with artificial stone-associated complicated silicosis. Safety and feasibility will also be assessed. Currently there are no treatments available for silicosis.
Participants will receive 5 mg/kg intravenous infliximab at weeks 0, 2, and 6, followed by maintenance infusions every 6 weeks until week 24. Infusions will be administered by registered nursing staff at the Alfred Ho
The STRIKE trial is a single-centre, investigator-initiated pilot study assessing the efficacy of infliximab in patients with artificial stone-associated complicated silicosis. Safety and feasibility will also be assessed. Currently there are no treatments available for silicosis. Participants will receive 5 mg/kg intravenous infliximab at weeks 0, 2, and 6, followed by maintenance infusions every 6 weeks until week 24. Infusions will be administered by registered nursing staff at the Alfred Hospital Medical Day Unit (MDU), following existing hospital protocols for infliximab. Nursing staff will already have familiarity with infliximab as it is administered in the MDU for various other indications. Adherence to this intervention will be assessed at clinical review at 6 weekly intervals (as written into the protocol) and confirmed by reviewing nursing notes on the electronic medical record. Attendance records for each participant will be logged in a trial spreadsheet for record-keeping.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We will recruit 20 adults from the Alfred Hospital Occupational Respiratory Clinic with complicated silicosis caused by artificial stone-associated silica exposure, and with evidence of lung function decline. People from culturally and linguistically diverse backgrounds will be eligible.
Exclusion criteria
(i) ongoing potential exposure to silica (i.e. still working in the stone benchtop industry), (ii) vaccination with live or bacterial vaccines within the prior 3 months, (iii) active or untreated latent tuberculosis, (iv) serious infections in the last 6 months (such as sepsis, abscess or severe opportunistic infections), (v) history of recurrent infection, (vi) history of severe hypersensitivity to infliximab, to other murine proteins or to any excipient of the product, (vii) history of chronic liver disease, (viii) history of severe cytopaenias, (ix) history of demyelinating disease e.g. multiple sclerosis (x) history of malignancy or lymphoproliferative disease within the last 5 years, (xi) current or recent (<4 weeks) use of immunosuppression, (xii) history of heart failure as determined on transthoracic echocardiography, including either left and right heart dysfunction (xiii) pregnancy or breastfeeding
Outcome results
None listed