E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002556 |
E.1.2 | Term | Ankylosing spondylitis |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Endpoint SPARCC (6-dvu) score of spine based on MR scan of axial skeleton 6 months after treatment. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Trial finishes after last patient has been assessed fully at the last visit (DXA scan at 12 months). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |