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

Phase 4

• Conditions: Ankylosing Spondylitis
• Interventions: Other: Placebo (NaCl 0.9%); Drug: Pamidronate

• Registration Number: NCT02313727
• Lead Sponsor: Bnai Zion Medical Center

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 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.

Study Timeline

• Status Verified: 2014-11
• Study Start: 2014-12
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-08
• Last Update Submitted: 2014-12-08
• Study First Posted: 2014-12-10
• Last Update Posted: 2014-12-10
• Primary Completion: 2017-06
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo (NaCl 0.9%)	placebo
pamidronate	Pamidronate	pamidronate

Primary Outcome Measures

Name	Time	Method
modified stock ankylosing spondylitis spine (mSASS) score	24 months	calculated by X-ray films of the spine
Bath ankylosing spondylitis radiographic index (BASRI)	24 months	calculated by X-ray films of the spine

Secondary Outcome Measures

Name	Time	Method
Bath ankylosing spondylitis disease activity index (BASDAI)	monthly from the date of randomization up to 24 months	calculated
Ankylosing spondylitis disease activity index (ASDAS)	monthly from the date of randomization up to 24 months	calculated
Bath ankylosing spondylitis functional index (BASFI)	monthly from the date of randomization up to 24 months	calculated
Bath ankylosing spondylitis metrology index (BASMI)	monthly from the date of randomization up to 24 months	calculated

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel