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

NCT ID: NCT02313727

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-09-30

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.

Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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pamidronate

pamidronate

Group Type ACTIVE_COMPARATOR

Pamidronate

Intervention Type DRUG

intravenous infusion of pamidronate 60 mg

placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo (NaCl 0.9%)

Intervention Type OTHER

intravenous infusion of NaCl 0.9% 500 ml

Interventions

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Pamidronate

intravenous infusion of pamidronate 60 mg

Intervention Type DRUG

Placebo (NaCl 0.9%)

intravenous infusion of NaCl 0.9% 500 ml

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bnai Zion Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

References

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Slobodin G, Rosner I, Feld J, Rimar D, Rozenbaum M, Boulman N, Odeh M. Pamidronate treatment in rheumatology practice: a comprehensive review. Clin Rheumatol. 2009 Dec;28(12):1359-64. doi: 10.1007/s10067-009-1256-2. Epub 2009 Aug 19.

Reference Type BACKGROUND
PMID: 19690938 (View on PubMed)

Slobodin G, Rosner I, Rimar D, Boulman N, Rozenbaum M, Odeh M. The synergistic efficacy of adalimumab and pamidronate in a patient with ankylosing spondylitis. Clin Rheumatol. 2010 Jul;29(7):793-4. doi: 10.1007/s10067-010-1378-6. Epub 2010 Jan 29.

Reference Type BACKGROUND
PMID: 20111975 (View on PubMed)

Pederson L, Ruan M, Westendorf JJ, Khosla S, Oursler MJ. Regulation of bone formation by osteoclasts involves Wnt/BMP signaling and the chemokine sphingosine-1-phosphate. Proc Natl Acad Sci U S A. 2008 Dec 30;105(52):20764-9. doi: 10.1073/pnas.0805133106. Epub 2008 Dec 15.

Reference Type BACKGROUND
PMID: 19075223 (View on PubMed)

Other Identifiers

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0099-14-BNZ

Identifier Type: -

Identifier Source: org_study_id