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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Pamidronate
* Other: Placebo (NaCl 0.9%)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pamidronate<br>pamidronate | Drug: Pamidronate<br>* intravenous infusion of pamidronate 60 mg<br>|
| Placebo Comparator: placebo<br>placebo | Other: Placebo (NaCl 0.9%)<br>* intravenous infusion of NaCl 0.9% 500 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified stock ankylosing spondylitis spine (mSASS) score | calculated by X-ray films of the spine | 24 months | 
| Bath ankylosing spondylitis radiographic index (BASRI) | calculated by X-ray films of the spine | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bath ankylosing spondylitis disease activity index (BASDAI) | calculated | monthly from the date of randomization up to 24 months | 
| Ankylosing spondylitis disease activity index (ASDAS) | calculated | monthly from the date of randomization up to 24 months | 
| Bath ankylosing spondylitis functional index (BASFI) | calculated | monthly from the date of randomization up to 24 months | 
| Bath ankylosing spondylitis metrology index (BASMI) | calculated | monthly from the date of randomization up to 24 months |