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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pamidronate | Active Comparator | pamidronate |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamidronate | Drug | intravenous infusion of pamidronate 60 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| modified stock ankylosing spondylitis spine (mSASS) score | calculated by X-ray films of the spine | 24 months |
| Bath ankylosing spondylitis radiographic index (BASRI) | calculated by X-ray films of the spine | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bath ankylosing spondylitis disease activity index (BASDAI) | calculated | monthly from the date of randomization up to 24 months |
| Ankylosing spondylitis disease activity index (ASDAS) | calculated |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Haifa | 38041 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19690938 | Background | 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. | |
| 20111975 | Background | 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. |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000077268 | Pamidronate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Placebo (NaCl 0.9%) |
| Other |
intravenous infusion of NaCl 0.9% 500 ml |
|
| monthly from the date of randomization up to 24 months |
| Bath ankylosing spondylitis functional index (BASFI) | calculated | monthly from the date of randomization up to 24 months |
| Bath ankylosing spondylitis metrology index (BASMI) | calculated | monthly from the date of randomization up to 24 months |
| 19075223 | Background | 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. |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |