Ankylosing Spondylitis
Conditions
Brief summary
It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for pamidronate) study. All patients with AS will receive treatment with TNF inhibitor, while randomization will be performed for pamidronate versus placebo group. Primary outcome will be the rate of radiographic progression of AS, calculated after 24 months of combined treatment.
Detailed description
It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for pamidronate) study. All patients with AS will receive treatment with tumor necrosis factor (TNF) inhibitor, as indicated by local guidelines. Randomization will be performed for pamidronate vs placebo group. Pamidronate will be prescribed as monthly intravenous infusion in the dose of 60 mg/month for the first 6 consecutive months of every study year. Primary outcome will be the rate of radiographic progression of ankylosing spondylitis (AS), calculated after 24 months of combined treatment. Clinical and laboratory disease parameters will serve as secondary outcomes. These outcomes as well as safety assessments will be performed on a monthly basis up to 24 months.
Interventions
DRUGPamidronate
intravenous infusion of pamidronate 60 mg
OTHERPlacebo (NaCl 0.9%)
intravenous infusion of NaCl 0.9% 500 ml
Sponsors
Janssen-Cilag Ltd.
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* presence of spinal syndesmophytes * normal renal and liver function * eligibility to receive anti-TNF treatment according to local guidelines
Exclusion criteria
* unwilling to sigh the informed consent * presence of significant systemic or organ-limited disorders, other than AS * any contraindication for anti-TNF or pamidronate treatment * presence of acute dental/periodontal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified stock ankylosing spondylitis spine (mSASS) score | 24 months | calculated by X-ray films of the spine |
| Bath ankylosing spondylitis radiographic index (BASRI) | 24 months | calculated by X-ray films of the spine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bath ankylosing spondylitis disease activity index (BASDAI) | monthly from the date of randomization up to 24 months | calculated |
| Ankylosing spondylitis disease activity index (ASDAS) | monthly from the date of randomization up to 24 months | calculated |
| Bath ankylosing spondylitis functional index (BASFI) | monthly from the date of randomization up to 24 months | calculated |
| Bath ankylosing spondylitis metrology index (BASMI) | monthly from the date of randomization up to 24 months | calculated |
Countries
Israel
Outcome results
None listed