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

Bnai Zion Medical Center

Status and phase: Unknown; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Other: Placebo (NaCl 0.9%); Drug: Pamidronate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02313727

0099-14-BNZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

pamidronate

Active Comparator group

Description:

pamidronate

Treatment:

Drug: Pamidronate

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Other: Placebo (NaCl 0.9%)