A report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative

Dougados, Maxime; Leclaire, P.; Heijde, Desirée van der; Bloch, D. A.; Bellamy, Nicholas; Altman, Roy D.

doi:10.1053/joca.2000.0361

Cited by 162 publications

(139 citation statements)

References 11 publications

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“…These include a high placebo effect, the design of the study, and the lack of efficacy of the drug itself (25). IA procedure, notably with injections of HA into the knee, is commonly associated with a high placebo response that might limit the ability to detect benefits of the treatment (8,22,25). However, in the present study we did not observe a high placebo response that may have skewed the results observed in the treatment group.…”

Section: Discussioncontrasting

confidence: 55%

“…The severity of pain was evaluated at each visit by use of a continuous 100-mm VAS assessing the global level of pain in the target hip, regardless of the circumstances over the previous 48 hours. Secondary outcomes were the proportion of responders, defined according to the OARSI criteria (22); the Western Ontario and McMaster Universities Osteoarthritis Index global score and subscores for pain, stiffness, and disability (23); the patient and physician global assessment of the severity of hip OA measured on a 100-mm VAS; and treatment with analgesics and NSAIDs. Outcomes were measured at inclusion and at baseline (immediately before injection).…”

Section: Methodsmentioning

confidence: 99%

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Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo‐controlled trial

Richette¹,

Ravaud²,

Conrozier³

et al. 2009

Arthritis & Rheumatism

106

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Objective. To evaluate the efficacy and tolerability of a single intraarticular (IA) injection of hyaluronic acid (HA) for the treatment of hip osteoarthritis (OA).Methods. A multicenter, randomized, parallelgroup, placebo-controlled trial was conducted over 3 months. Patients (older than 30 years) with symptomatic hip OA (pain score of >40 mm on a visual analog scale [VAS]) and a Kellgren/Lawrence grade of 2 or 3 were randomly assigned to receive 1 fluoroscopically guided IA injection of HA (2.5 ml) or placebo (2.5 ml). Patients were followed up for 3 months. The main outcome measure was pain score on a VAS (100 mm) at month 3 compared with baseline. Secondary outcome measures were the proportion of responders defined by Osteoarthritis Research Society International criteria; Western Ontario and McMaster Universities Osteoarthritis Index subscores for pain, stiffness, and disability; and patient and physician global assessment. Randomization was computer generated. HA and placebo preparations were placed in numbered identical containers, and syringes were covered with masking tape. Physicians assessing outcomes were blinded with regard to group assignment.Results. Eighty-five patients were randomized to the HA group (n ‫؍‬ 42) or placebo group (n ‫؍‬ 43). Baseline characteristics were similar between the 2 groups. At 3 months, the decrease in pain score did not differ between the HA and placebo groups in the intentto-treat analysis (mean ؎ SD decrease 7.8 ؎ 24.9 mm with HA versus 9.1 ؎ 27.4 mm with placebo; P ‫؍‬ 0.98). The responder rates were 33.3% and 32.6% in the HA and placebo groups, respectively (P ‫؍‬ 0.94). Other secondary end points did not differ between the groups, nor did use of rescue medication or frequency of adverse events.Conclusion. Our findings indicate that a single IA injection of HA is no more effective than placebo in treating the symptoms of hip OA.Osteoarthritis (OA) is the most common type of arthritis and the major cause of disability in elderly populations worldwide. Hip OA is the second most frequent form of OA affecting a large joint, and its prevalence ranges from 3% to 11% in populations older than 35 years (1-3).Current therapies for hip OA include a combination of nonpharmacologic and pharmacologic treatments (4-6). Viscosupplementation is an intraarticular (IA) therapeutic modality that is based on the physiologic importance of hyaluronic acid (HA) in synovial ClinicalTrials.gov identifier: NCT00330135.

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Section: Discussioncontrasting

confidence: 55%

Section: Methodsmentioning

confidence: 99%

Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo‐controlled trial

Richette¹,

Ravaud²,

Conrozier³

et al. 2009

Arthritis & Rheumatism

106

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“…Further, a change of 20 mm has been defined as the minimum required for classification as a primary responder by Osteoarthritis Research Society International (29,30). Accordingly, we deemed that an improvement in the PES-treated group of 20 mm greater than that achieved in the placebo group would constitute a clinically meaningful and important difference.…”

Section: Methodsmentioning

confidence: 99%

The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: Results of a double‐blind, randomized, placebo‐controlled, repeated‐measures trial

Fary¹,

Carroll²,

Briffa³

et al. 2011

Arthritis & Rheumatism

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Objective. To determine the effectiveness of subsensory, pulsed electrical stimulation (PES) in the symptomatic management of osteoarthritis (OA) of the knee.Methods. This was a double-blind, randomized, placebo-controlled, repeated-measures trial in 70 participants with clinical and radiographically diagnosed OA of the knee who were randomized to either PES or placebo. Conclusion. In this sample of subjects with mildto-moderate symptoms and moderate-to-severe radiographic OA of the knee, 26 weeks of PES was no more effective than placebo.

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“…visual analogue scale [VAS] 31,32 These criteria have been validated and were used in four of the larger lumiracoxib studies reported in this review to analyse response to treatment. This review examines all clinical efficacy studies conducted to date that compared lumiracoxib with placebo, traditional NSAIDs or other COX-2 selective inhibitors in patients with OA.…”

Section: Efficacy Of Lumiracoxib In Osteoarthritismentioning

confidence: 99%

Efficacy of Lumiracoxib in Osteoarthritis: A Review of Nine Studies

et al. 2005

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Lumiracoxib is a cyclooxygenase-2 selective inhibitor in development for the treatment of osteoarthritis (OA), rheumatoid arthritis and acute pain. We reviewed nine clinical studies of 1 − 52 weeks' duration demonstrating the efficacy of lumiracoxib in OA. Male and female patients aged ≥ 18 years with primary OA of the hand, hip or knee received lumiracoxib, placebo or active comparators (diclofenac, celecoxib or rofecoxib). Lumiracoxib provided consistent reductions in OA pain intensity and improvements in the patient's global assessment of disease activity and functional status (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire or the Australian/Canadian OA Hand Index). These results were superior to placebo and similar to the active comparators tested. In addition, lumiracoxib was consistently superior to placebo and generally similar to active comparators in terms of the new Outcome Measures in Clinical Trials and Osteoarthritis Research Society International criteria. These were used to provide a single measure of response to treatment, taking into account pain, the patient's global assessment of disease activity and functional status.

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A report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative

Abstract: Based on data from clinical trials, two sets of responder criteria have been developed that can categorize an individual's responses to treatment in a clinical trial. These responder criteria require validation in additional datasets.

Cited by 162 publications

References 11 publications

Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo‐controlled trial

Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo‐controlled trial

The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: Results of a double‐blind, randomized, placebo‐controlled, repeated‐measures trial

Efficacy of Lumiracoxib in Osteoarthritis: A Review of Nine Studies

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