Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: A multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz

Arthritis Research and Therapy

Volumn 17, Issue 1, 2015, Pages

  Zhang, Heng ^a   Zhang, Ke ^b   Zhang, Xianlong ^c   Zhu, Zhenan ^d   Yan, Shigui ^e   Sun, Tiansheng ^f   Guo, Ai ^g   Jones, John ^h   Steen, R Grant ^h   Shan, Bin ⁱ   Zhang, Jenny ⁱ   Lin, Jianhao ^a  

^a PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

^b PEKING UNIVERSITY THIRD HOSPITAL   (China)

^c Jinshan Branch   (China)

^d SHANGHAI SECOND MEDICAL UNIVERSITY   (China)

^e THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE   (China)

^f CHINESE PLA GENERAL HOSPITAL   (China)

^g CAPITAL MEDICAL UNIVERSITY   (China)

^h BIOVENTUS LLC   (United States)

ⁱ CCCC Water Transportation   (China)

Author keywords

[No Author keywords available]

Indexed keywords

HYALURONIC ACID; PARACETAMOL; IMMUNOLOGICAL ADJUVANT;

ADULT; AGED; ANALGESIA; ARTHRALGIA; ARTHROPATHY; ARTICLE; CHINA; CLINICAL ASSESSMENT; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPICONDYLITIS; FEMALE; HUMAN; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; JOINT EFFUSION; JOINT SWELLING; KNEE FUNCTION; KNEE OSTEOARTHRITIS; LIMB DISEASE; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MUSCLE WEAKNESS; MUSCULOSKELETAL DISEASE; MYALGIA; PHYSICAL ACTIVITY; RANDOMIZED CONTROLLED TRIAL; SELF EVALUATION; SKIN DISEASE; TREATMENT OUTCOME; TREATMENT REFUSAL; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; CLINICAL TRIAL; DOSE RESPONSE; FOLLOW UP; INTRAARTICULAR DRUG ADMINISTRATION; KNEE; OSTEOARTHRITIS, KNEE; PROSPECTIVE STUDY;

ADJUVANTS, IMMUNOLOGIC; ADULT; AGED; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYALURONIC ACID; INJECTIONS, INTRA-ARTICULAR; KNEE JOINT; MALE; MIDDLE AGED; OSTEOARTHRITIS, KNEE; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84926633934     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/s13075-015-0557-x     Document Type: Article

References (49)

1. World Health Organization. The global burden of disease. Geneva: World Health Organization; 2008. p. 35.
2. Schofield DJ, Shrestha RN, Percival R, Passey ME, Callander EJ, Kelly SJ. The personal and national costs of lost labour force participation due to arthritis: an economic study. BMC Public Health. 2013;13:188.
3. Conaghan PG, Dickson J, Grant RL. Guideline Development Group. Care and management of osteoarthritis in adults: summary of NICE guidance. BMJ. 2008;336:502-3.
4. Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, et al. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010;18:476-99.
5. Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012;85:49-56.
6. Waddell DD. Viscosupplementation with hyaluronans for osteoarthritis of the knee: clinical efficacy and economic implications. Drugs Aging. 2007;24:629-42.
7. Arnold W, Fullerton DS, Holder S, May CS. Viscosupplementation: managed care issues for osteoarthritis of the knee. J Manag Care Pharm. 2007;4:S3-19.
8. Waddell DD, Bricker DC. Total knee replacement delayed with Hylan G-F 20 use in patients with grade IV osteoarthritis. J Manag Care Pharm. 2007;13:113-21.
9. Mar J, Romero Jurado M, Arrospide A, Enrique Fidalgo A, Soler LB. Cost-analysis of viscosupplementation treatment with hyaluronic acid in candidate knee replacement patients with osteoarhritis. Rev Esp Cir Ortop Traumatol. 2013;57:6-14.
10. van Jonbergen HP, Poolman RW, van Kampen A. Isolated patellofemoral osteoarthritis. Acta Orthop. 2010;81:199-205.
11. Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, et al. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013;471:215-20.
12. Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004;328:869.
13. Neustadt DH. Long-term efficacy and safety of intra-articular sodium hyaluronate (Hyalgan) in patients with osteoarthritis of the knee. Clin Exp Rheumatol. 2003;21:307-11.
14. Waddell DD, Bricker DC. Clinical experience with the effectiveness and tolerability of hylan G-F 20 in 1047 patients with osteoarthritis of the knee. J Knee Surg. 2006;19:19-27.
15. Hempfling H. Intra-articular hyaluronic acid after knee arthroscopy: a two-year study. Knee Surg Sports Traumatol Arthrosc. 2007;15:537-46.
16. Turajane T, Labpiboonpong V, Maungsiri S. Cost analysis of intra-articular sodium hyaluronate treatment in knee osteoarthritis patients who failed conservative treatment. J Med Assoc Thai. 2007;90:1839-44.
17. Turajane T, Amphansap T, Labpiboonpong V, Maungsiri S. Total knee replacement following repeated cycles of intra-articular sodium hyaluronate (500-730 Kda) in failed conservative treatment of knee osteoarthritis: a 54-month follow-up. J Med Assoc Thai. 2009;92:S63-8.
18. Phiphobmongkol V, Sudhasaneya V. The effectiveness and safety of intra-articular injection of sodium hyaluronate (500-730 kDa) in the treatment of patients with painful knee osteoarthritis. J Med Assoc Thai. 2009;92:1287-94.
19. Miller LE, Block JE. US-approved intra-articular hyaluronic acid injections are safe and effective in patients with knee osteoarthritis: Systematic review and meta-Analysis of randomized, saline-controlled trials. Clin Med Insights Arthritis Musculoskelet Disord. 2013;6:57-63.
20. Rutjes AW, Juni P, da Costa BR, Trelle S, Nüesch E, Reichenbach S. Viscosupplementation for osteoarthritis of the knee: a systematic review and meta-analysis. Ann Intern Med. 2012;157:180-91.
21. Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham 3rd CO, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/ European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010;69:1580-8.
22. McManus CA, Schnyer RN, Kong J, Nguyen LT, Hyun Nam B, Goldman R, et al. Sham acupuncture devices - practical advice for researchers. Acupunct Med. 2007;25:36-40.
23. Bellamy N. WOMAC Osteoarthritis Index user guide. Brisbane, Australia: Version V; 2002.
24. Xie F, Li SC, Goeree R, Tarride JE, O'Reilly D, Lo NN, et al. Validation of Chinese Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in patients scheduled for total knee replacement. Qual Life Res. 2008;17:595-601.
25. Pham T, van der Heijde D, Lassere M, Altman RD, Anderson JJ, Bellamy N, et al. Outcome variables for osteoarthritis clinical trials: the OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30:1648-54.
26. Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006;14:154-62.
27. Kenward MG, Roger JH. Small sample inference for fixed effects from restricted maximum likelihood. Biometrics. 1997;53:983-97.
28. Altman RD, Akermark C, Beaulieu AD, Schnitzer T. Durolane International Study Group. Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2004;12:642-9.
29. Leighton R, Akermark C, Therrien R, Richardson JB, Andersson M, Todman MG, et al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014;22:17-25.
30. Altman RD, Rosen JE, Bloch DA, Hatoum HT, Korner P. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). Semin Arthritis Rheum. 2009;39:1-9.
31. Navarro-Sarabia F, Coronel P, Collantes E, Navarro FJ, de la Serna AR, Naranjo A, et al. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project. Ann Rheum Dis. 2011;70:1957-62.
32. Zhang YS, Wang ZX. Randomized controlled clinical trials for treatment of knee osteoarthritis by warm acupuncture combined with intra-articular injection of sodium hyaluronate. Zhen Ci Yan Jiu. 2011;36:373-6.
33. Wu MX, Li XH, Lin MN, Jia XR, Mu R, Wan WR, et al. Clinical study on the treatment of knee osteoarthritis of Shen-Sui insufficiency syndrome type by electroacupuncture. Chin J Integr Med. 2010;16:291-7.
34. Xu HT, Chen Y, Chen LK, Li JY, Zhang W, Wu B. Effect of various intervention factors on MMP-3 and TIMP-1 level in synovial fluid in knee joints with osteroarthritis. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2008;33:47-52.
35. Tang X, Pei FX, Zhou ZK, Liu G, Shen B, Kang PD, et al. A randomized, single-blind comparison of the efficacy and tolerability of hyaluronate acid and meloxicam in adult patients with Kashin-Beck disease of the knee. Clin Rheumatol. 2012;31:1079-86.
36. Gao R, Li X. Risk assessment and aspirin use in Asian and western populations. Vasc Health Risk Manag. 2010;6:943-56.
37. Zhao L, Pickering G. Paracetamol metabolism and related genetic differences. Drug Metab Rev. 2011;43:41-52.
38. Bock KW, Schrenk D, Forster A, Griese EU, Mörike K, Brockmeier D, et al. The influence of environmental and genetic factors on CYP2D6, CYP1A2 and UDP-glucuronosyltransferases in man using sparteine, caffeine, and paracetamol as probes. Pharmacogenetics. 1994;4:209-18.
39. Yosipovitch G, Meredith G, Chan YH, Coh CL. Do ethnicity and gender have an impact on pain thresholds in minor dermatologic procedures? A study on thermal pain perception thresholds in Asian ethnic groups. Skin Res Technol. 2004;10:38-42.
40. Hsieh AY, Tripp DA, Ji LJ, Sullivan MJ. Comparisons of catastrophizing, pain attitudes, and cold-pressor pain experience between Chinese and European Canadian young adults. J Pain. 2010;11:1187-94.
41. Hsieh AY, Tripp DA, Ji LJ. The influence of ethnic concordance and discordance on verbal reports and nonverbal behaviours of pain. Pain. 2011;152:2016-22.
42. Rahim-Williams B, Riley JL, Williams AK, Fillingim RB. A quantitative review of ethnic group differences in experimental pain response: do biology, psychology, and culture matter? Pain Med. 2012;13:522-40.
43. Chan MY, Hamamura T, Janschewitz K. Ethnic differences in physical pain sensitivity: role of acculturation. Pain. 2013;154:119-23.
44. Wartolowska K, Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014;348:g3253.
45. Bellamy N, Campbell J, Welch V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006;9:CD005321.
46. Bannuru RR, Schmid CH, Sullivan MC, Kent DM, Wong JB, McAlindon TE. Differential response of placebo treatments in osteoarthritis trials: a systematic review and network meta-analysis. OA Cart. 2014;22:S24-5.
47. Linde K, Fassler M, Meissner K. Placebo interventions, placebo effects and clinical practice. Philos Trans R Soc Lond B Biol Sci. 2011;366:1905-12.
48. Enck P, Klosterhalfen S, Weimar K, Horing B, Zipfel S. The placebo response in clinical trials: more questions than answers. Philos Trans R Soc Lond B Biol Sci. 2011;366:1889-95.
49. Garattini S, Bertele V. Ethics in clinical research. J Hepatol. 2009;51:792-7.