Ankylosing Spondylitis MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Conditions
Interventions
Trade Name: Aclasta
Pharmaceutical Form: Intravenous infusion
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the study the patient must have Ankylosing Spondylitis, be >18y old, have a BASDAI (composite clinical disease activity score) =4.15, be able to have a spinal MR and have one or more lesions on axial MR characteristic of inflammatory lesions of AS. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients <18y, prisoners, complete spinal ankylosis, those unable to give written consent themselves, renal dysfunction (Chronic Kidney Disease grade 4 or 5 by MDRD GFR estimation <30ml/min [e-GFR]), previous anti-TNFalpha therapy in last year, previous reaction to zoledronate, patients with obvious poor dentition/oral health, or those who have recently had root dental work or root/extraction dental work planned within the study period. Also to be excluded: All women of child-bearing potential; pregnant women and those breast-feeding; all those unable to give written consent themselves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether Aclasta (5mg iv) is likely to have a therapeutic effect on the inflammatory lesions of Ankylosing Spondylitis (AS) assessed by axial skeletal Magnetic Resonance (MR) scanning 6 months after treatment;Secondary Objective: To evaluate any changes in validated clinical indices 3 and 6 months after Aclasta treatment; to evaluate any therapeutic effect of Aclasta on the inflammatory lesions of AS assessed by MR 3 months after treatment; to evaluate change in spinal bone density 12 months after Aclasta treatment assessed by Dual X-Ray Absorptiometry scanning.;Primary end point(s): Endpoint SPARCC (6-dvu) score of spine based on MR scan of axial skeleton 6 months after treatment. | — |
Countries
United Kingdom
Outcome results
None listed