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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-000087-25-GB |
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Date of registration:
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27/07/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07
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Scientific title:
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An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07 |
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Date of first enrolment:
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22/10/2007 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000087-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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:
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
MedDRA version: 9.1
Level: LLT
Classification code 10002556
Term: Ankylosing spondylitis
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Intervention(s)
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Trade Name: Aclasta
Pharmaceutical Form: Intravenous infusion
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Primary Outcome(s)
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Primary end point(s): Endpoint SPARCC (6-dvu) score of spine based on MR scan of axial skeleton 6 months after treatment.
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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.
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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
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Secondary ID(s)
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n/a
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A090913
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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