Status:
UNKNOWN
Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression
Lead Sponsor:
Bnai Zion Medical Center
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Ankylosing Spondylitis
Eligibility:
MALE
18+ years
Phase:
PHASE4
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 ...
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, a...
Eligibility Criteria
Inclusion
- presence of spinal syndesmophytes
- normal renal and liver function
- eligibility to receive anti-TNF treatment according to local guidelines
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02313727
Start Date
December 1 2014
End Date
September 1 2017
Last Update
December 10 2014
Active Locations (1)
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1
Bnai Zion Medical Center
Haifa, Israel, 38041