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      Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial

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          Abstract

          Objectives

          Celecoxib is a selective cyclooxygenase (COX)-2 inhibitor that is commonly used to reduce the incidence of gastrointestinal (GI) complications in patients with rheumatoid arthritis (RA). CELBESTA® is a generic equivalent to CELEBREX®, a celecoxib preparation. This study compared the efficacy and safety of CELBESTA® and CELEBREX® in patients with RA.

          Methods

          This was a multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority clinical trial. The primary endpoint was a change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale after 6 weeks of treatment.

          Results

          After a washout period, 119 eligible subjects were randomized to one of two groups (CELBESTA® group, n = 61; CELEBREX® group, n = 58). CELBESTA® was not inferior to CELEBREX® because the upper limit of two-sided 95% confidence interval (CI) for the difference between the two groups (difference in the least square [LS] mean, −8.68 mm; two-sided 95% CI −16.59 mm to −0.77 mm) was less than the non-inferiority margin (10 mm). There were no significant differences in GI complications and renal toxicity.

          Conclusions

          CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.

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          Most cited references13

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          Guidelines for the management of rheumatoid arthritis: 2002 Update.

          (2002)
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            The costs and consequences of adequately managed chronic non-cancer pain and chronic neuropathic pain.

            Chronic pain is distressing for patients and a burden on healthcare systems and society. Recent research demonstrates different aspects of the negative impact of chronic pain and the positive impact of successful treatment, making an overview of the costs and consequences of chronic pain appropriate.
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              Therapeutic strategies for rheumatoid arthritis.

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                Author and article information

                Journal
                J Int Med Res
                J. Int. Med. Res
                IMR
                spimr
                The Journal of International Medical Research
                SAGE Publications (Sage UK: London, England )
                0300-0605
                1473-2300
                26 June 2020
                June 2020
                : 48
                : 6
                : 0300060520931323
                Affiliations
                [1 ]Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea
                [2 ]Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea
                [3 ]Division of Rheumatology, Department of Internal Medicine, Gyeongsang National University Hospital, JinJu, Republic of Korea
                [4 ]Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Republic of Korea
                [5 ]Division of Rheumatology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea
                [6 ]Division of Rheumatology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea
                [7 ]Division of Rheumatology, Department of Internal Medicine, Nowon Eulji Medical Center, Seoul, Republic of Korea
                [8 ]Division of Rheumatology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Republic of Korea
                [9 ]Division of Rheumatology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea
                [10 ]Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea
                Author notes

                *Hyun-Sook Kim and Won-Ho Choi contributed equally to this manuscript.

                [*]Seung-Jae Hong, Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyung Hee University Medical Center, 23 Kyunghee-daero, Dongdaemun-gu, Seoul 02447, Republic of Korea. Emails: hsj718@ 123456hanmail.net ; hsj718@ 123456khu.ac.kr
                Author information
                https://orcid.org/0000-0001-9213-7140
                https://orcid.org/0000-0001-5507-3897
                https://orcid.org/0000-0001-9442-3300
                https://orcid.org/0000-0002-9803-529X
                Article
                10.1177_0300060520931323
                10.1177/0300060520931323
                7325469
                32589073
                ac0d5be0-749d-473b-9f4b-d978fb11f4c2
                © The Author(s) 2020

                Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 5 November 2019
                : 12 May 2020
                Funding
                Funded by: Dong-A ST Co., Ltd;
                Funded by: Soonchunhyang University, FundRef https://doi.org/10.13039/501100002560;
                Categories
                Prospective Clinical Research Report
                Custom metadata
                corrected-proof
                ts2

                celbesta®,celebrex®,korea,rheumatoid arthritis,pain relief,non-inferiority,gastrointestinal toxicity,renal toxicity

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