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

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ClinicalTrials.gov Identifier: NCT02313727
Recruitment Status : Unknown
Verified November 2014 by Bnai Zion Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Bnai Zion Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Pamidronate Other: Placebo (NaCl 0.9%) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Combined Treatment With TNF (Tumor Necrosis Factor) Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression
Study Start Date : December 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: pamidronate
pamidronate
Drug: Pamidronate
intravenous infusion of pamidronate 60 mg

Placebo Comparator: placebo
placebo
Other: Placebo (NaCl 0.9%)
intravenous infusion of NaCl 0.9% 500 ml




Primary Outcome Measures :
  1. modified stock ankylosing spondylitis spine (mSASS) score [ Time Frame: 24 months ]
    calculated by X-ray films of the spine

  2. Bath ankylosing spondylitis radiographic index (BASRI) [ Time Frame: 24 months ]
    calculated by X-ray films of the spine


Secondary Outcome Measures :
  1. Bath ankylosing spondylitis disease activity index (BASDAI) [ Time Frame: monthly from the date of randomization up to 24 months ]
    calculated

  2. Ankylosing spondylitis disease activity index (ASDAS) [ Time Frame: monthly from the date of randomization up to 24 months ]
    calculated

  3. Bath ankylosing spondylitis functional index (BASFI) [ Time Frame: monthly from the date of randomization up to 24 months ]
    calculated

  4. Bath ankylosing spondylitis metrology index (BASMI) [ Time Frame: monthly from the date of randomization up to 24 months ]
    calculated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313727


Locations
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Israel
Bnai Zion Medical Center
Haifa, Israel, 38041
Sponsors and Collaborators
Bnai Zion Medical Center
Janssen-Cilag Ltd.

Publications:
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Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT02313727     History of Changes
Other Study ID Numbers: 0099-14-BNZ
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis