Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- modified stock ankylosing spondylitis spine (mSASS) score [24 months]
calculated by X-ray films of the spine
- Bath ankylosing spondylitis radiographic index (BASRI) [24 months]
calculated by X-ray films of the spine
Secondary Outcome Measures
- Bath ankylosing spondylitis disease activity index (BASDAI) [monthly from the date of randomization up to 24 months]
calculated
- Ankylosing spondylitis disease activity index (ASDAS) [monthly from the date of randomization up to 24 months]
calculated
- Bath ankylosing spondylitis functional index (BASFI) [monthly from the date of randomization up to 24 months]
calculated
- Bath ankylosing spondylitis metrology index (BASMI) [monthly from the date of randomization up to 24 months]
calculated
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bnai Zion Medical Center | Haifa | Israel | 38041 |
Sponsors and Collaborators
- Bnai Zion Medical Center
- Janssen-Cilag Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 0099-14-BNZ