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

NCT02313727 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-12-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pamidronate

intravenous infusion of pamidronate 60 mg

OTHER

Placebo (NaCl 0.9%)

intravenous infusion of NaCl 0.9% 500 ml

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Bnai Zion Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313727 on ClinicalTrials.gov