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

December 8, 2014 updated by: Bnai Zion Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 38041
        • Bnai Zion Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified stock ankylosing spondylitis spine (mSASS) score
Time Frame: 24 months
calculated by X-ray films of the spine
24 months
Bath ankylosing spondylitis radiographic index (BASRI)
Time Frame: 24 months
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)
Time Frame: monthly from the date of randomization up to 24 months
calculated
monthly from the date of randomization up to 24 months
Ankylosing spondylitis disease activity index (ASDAS)
Time Frame: monthly from the date of randomization up to 24 months
calculated
monthly from the date of randomization up to 24 months
Bath ankylosing spondylitis functional index (BASFI)
Time Frame: monthly from the date of randomization up to 24 months
calculated
monthly from the date of randomization up to 24 months
Bath ankylosing spondylitis metrology index (BASMI)
Time Frame: monthly from the date of randomization up to 24 months
calculated
monthly from the date of randomization up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Collaborators

Janssen-Cilag Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0099-14-BNZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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