Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bnai Zion Medical Center
• Collaborator: Janssen-Cilag Ltd.
• Treatments: Pamidronate

Criteria

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