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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02313727
• Other study ID #: 0099-14-BNZ
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 1, 2014
• Last updated: December 8, 2014
• Start date: December 2014
• Est. completion date: September 2017

Study information

• Verified date: November 2014
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. Primary outcome will be the rate of radiographic progression of AS, calculated after 24 months of combined treatment.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Pamidronate
intravenous infusion of pamidronate 60 mg

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

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Bnai Zion Medical Center	Janssen-Cilag Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified stock ankylosing spondylitis spine (mSASS) score	calculated by X-ray films of the spine	24 months	No
Primary	Bath ankylosing spondylitis radiographic index (BASRI)	calculated by X-ray films of the spine	24 months	No
Secondary	Bath ankylosing spondylitis disease activity index (BASDAI)	calculated	monthly from the date of randomization up to 24 months	No
Secondary	Ankylosing spondylitis disease activity index (ASDAS)	calculated	monthly from the date of randomization up to 24 months	No
Secondary	Bath ankylosing spondylitis functional index (BASFI)	calculated	monthly from the date of randomization up to 24 months	No
Secondary	Bath ankylosing spondylitis metrology index (BASMI)	calculated	monthly from the date of randomization up to 24 months	No