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Ankylosing SpondylitisPhase 4NCT02313727

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

A Phase 4 study testing Pamidronate in people with Ankylosing Spondylitis, run by Bnai Zion Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Pamidronate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteIsrael
Study dates
Dec 2014to Sep 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • presence of spinal syndesmophytes
  • normal renal and liver function
  • eligibility to receive anti-TNF treatment according to local guidelines

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Israel1 site

  • Bnai Zion Medical Center

    Haifa, 38041

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Being tested
Pamidronate, Placebo (NaCl 0.9%)
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PamidronateDrug

    intravenous infusion of pamidronate 60 mg

  • Placebo (NaCl 0.9%)Other

    intravenous infusion of NaCl 0.9% 500 ml

Study groups in NCT02313727
Study groupRoleWhat they receive
pamidronateActive comparatorpamidronate
Receives: Drug: Pamidronate
placeboPlacebo comparatorplacebo
Receives: Other: Placebo (NaCl 0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. modified stock ankylosing spondylitis spine (mSASS) score

    calculated by X-ray films of the spine

    Measured: 24 months

  2. Bath ankylosing spondylitis radiographic index (BASRI)

    calculated by X-ray films of the spine

    Measured: 24 months

Secondary outcomes (4)

  1. Bath ankylosing spondylitis disease activity index (BASDAI)

    calculated

    Measured: monthly from the date of randomization up to 24 months

  2. Ankylosing spondylitis disease activity index (ASDAS)

    calculated

    Measured: monthly from the date of randomization up to 24 months

  3. Bath ankylosing spondylitis functional index (BASFI)

    calculated

    Measured: monthly from the date of randomization up to 24 months

  4. Bath ankylosing spondylitis metrology index (BASMI)

    calculated

    Measured: monthly from the date of randomization up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313727
Sponsor's protocol ID
0099-14-BNZ
Status last verified
Nov 2014
First submitted
1 Dec 2014
Last updated
10 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19690938

  • 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.

    PubMed 20111975

  • 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.

    PubMed 19075223

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pamidronate in people with Ankylosing Spondylitis, run by Bnai Zion Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified stock ankylosing spondylitis spine (mSASS) score (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313727, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.

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