NCT02313727

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

Combined Treatment With TNF (Tumor Necrosis Factor) Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Bnai Zion Medical Center · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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, as indicated by local guidelines. Randomization will be performed for pamidronate vs placebo group. Pamidronate will be prescribed as monthly intravenous infusion in the dose of 60 mg/month for the first 6 consecutive months of every study year. Primary outcome will be the rate of radiographic progression of ankylosing spondylitis (AS), calculated after 24 months of combined treatment. Clinical and laboratory disease parameters will serve as secondary outcomes. These outcomes as well as safety assessments will be performed on a monthly basis up to 24 months.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Pamidronate	intravenous infusion of pamidronate 60 mg
OTHER	Placebo (NaCl 0.9%)	intravenous infusion of NaCl 0.9% 500 ml

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2014-12-10
• Last updated: 2014-12-10

Locations

1 site across 1 country: Israel