A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee

Graverand, Marie‐Pierre Hellio Le; Clemmer, R.; Redifer, Patricia; Brunell, Robert; Hayes, Curtis W.; Brandt, Kenneth D.; Abramson, Steven B.; Manning, Pamela T.; Miller, Colin G.; Vignon, E.

doi:10.1136/annrheumdis-2012-202239

Cited by 112 publications

(67 citation statements)

References 43 publications

(37 reference statements)

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“…In addition, progression of some imaging pathologies may have limited clinical significance. Tables 3 and 4 summarise the results of the 28 primary studies in which imaging was applied to predict treatment response 14 84 156–176. Moreover, an existing SLR was available, without a quantitative synthesis 177.…”

Section: Resultsmentioning

confidence: 99%

EULAR recommendations for the use of imaging in the clinical management of peripheral joint osteoarthritis

et al. 2017

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The increased information provided by modern imaging has led to its more extensive use. Our aim was to develop evidence-based recommendations for the use of imaging in the clinical management of the most common arthropathy, osteoarthritis (OA). A task force (including rheumatologists, radiologists, methodologists, primary care doctors and patients) from nine countries defined 10 questions on the role of imaging in OA to support a systematic literature review (SLR). Joints of interest were the knee, hip, hand and foot; imaging modalities included conventional radiography (CR), MRI, ultrasonography, CT and nuclear medicine. PubMed and EMBASE were searched. The evidence was presented to the task force who subsequently developed the recommendations. The strength of agreement for each recommendation was assessed. 17 011 references were identified from which 390 studies were included in the SLR. Seven recommendations were produced, covering the lack of need for diagnostic imaging in patients with typical symptoms; the role of imaging in differential diagnosis; the lack of benefit in monitoring when no therapeutic modification is related, though consideration is required when unexpected clinical deterioration occurs; CR as the first-choice imaging modality; consideration of how to correctly acquire images and the role of imaging in guiding local injections. Recommendations for future research were also developed based on gaps in evidence, such as the use of imaging in identifying therapeutic targets, and demonstrating the added value of imaging. These evidence-based recommendations and related research agenda provide the basis for sensible use of imaging in routine clinical assessment of people with OA.

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Section: Resultsmentioning

confidence: 99%

EULAR recommendations for the use of imaging in the clinical management of peripheral joint osteoarthritis

et al. 2017

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“…Loss to follow-up was high, but in the same range as in other large trials in osteoarthritis 22. Unfortunately, the reasons for loss to follow-up were not provided in detail.…”

mentioning

confidence: 83%

Strontium ranelate: ready for clinical use as disease-modifying osteoarthritis drug?

Lafeber

Laar

2013

Ann Rheum Dis

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“…Current nonsurgical treatments target symptoms and function, with low-to-moderate efficacy (4,5). The potential of a combined beneficial effect on joint structure and symptoms in OA as a result of treatment with diacerein, glucosamine, doxycycline, risedronate, chondroitin sulfate, strontium ranelate, or cindunistat has been investigated (6)(7)(8)(9)(10)(11)(12)(13). However, no pharmacologic treatment or other treatment has been shown to have unequivocally beneficial effects on the structural characteristics of joint damage in OA that translate into clinical benefit (14).…”

mentioning

confidence: 99%

Intraarticular Sprifermin (Recombinant Human Fibroblast Growth Factor 18) in Knee Osteoarthritis: A Randomized, Double‐Blind, Placebo‐Controlled Trial

Lohmander

Hellot

Dreher³

et al. 2014

Arthritis & Rheumatology

228

177

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Objective. To evaluate the efficacy and safety of intraarticular sprifermin (recombinant human fibroblast growth factor 18) in the treatment of symptomatic knee osteoarthritis (OA).Methods. The study was a randomized, doubleblind, placebo-controlled, proof-of-concept trial. Intraarticular sprifermin was evaluated at doses of 10 g, 30 g, and 100 g. The primary efficacy end point was change in central medial femorotibial compartment cartilage thickness at 6 months and 12 months as determined using quantitative magnetic resonance imaging (qMRI). The primary safety end points were nature, incidence, and severity of local and systemic treatment-emergent adverse events (AEs) and acute inflammatory reactions, as well as results of laboratory assessments. Secondary end points included changes in total and compartment femorotibial cartilage thickness and volume as assessed by qMRI, changes in joint space width (JSW) seen on radiographs, and pain scores on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results. One hundred ninety-two patients were randomized and evaluated for safety, 180 completed the trial, and 168 were evaluated for the primary efficacy end point. We found no statistically significant dose response in change in central medial femorotibial compartment cartilage thickness. Sprifermin was associated with statistically significant, dose-dependent reductions in loss of total and lateral femorotibial cartilage thickness and volume and in JSW narrowing in the lateral femorotibial compartment. All groups had improved WOMAC pain scores, with statistically significantly less improvement at 12 months in patients receiving the 100-g dose of sprifermin as compared with those receiving placebo. There was no significant difference in serious AEs, treatment-emergent AEs, or acute inflammatory reactions between sprifermin and placebo groups. Conclusion. No statistically significant relation-ClinicalTrials.gov identifier: NCT01033994.

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A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee

Abstract: Cindunistat (50 or 200 mg/day) did not slow the rate of JSN versus placebo. After 48-weeks, KLG2 patients showed less JSN; however, the improvement was not sustained at 96-weeks. iNOS inhibition did not slow OA progression in KLG3 patients. CLINICAL TRIAL LISTING: NCT00565812.

Cited by 112 publications

References 43 publications

EULAR recommendations for the use of imaging in the clinical management of peripheral joint osteoarthritis

EULAR recommendations for the use of imaging in the clinical management of peripheral joint osteoarthritis

Strontium ranelate: ready for clinical use as disease-modifying osteoarthritis drug?

Intraarticular Sprifermin (Recombinant Human Fibroblast Growth Factor 18) in Knee Osteoarthritis: A Randomized, Double‐Blind, Placebo‐Controlled Trial

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