Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis
Infliximab, an inhibitor of TNF-α, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline serum TNF-α could be considered as a key indicator for optimal dosing of infliximab for RA treatment to achieve the clinical response and its sus...
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| Format: | Article |
| Language: | English |
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Elsevier
2017-12-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865417300819 |
| _version_ | 1819267110392561664 |
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| author | Koji Oba Nao Horie Norihiro Sato Kazuyoshi Saito Tsutomu Takeuchi Tsuneyo Mimori Nobuyuki Miyasaka Takao Koike Yoshiya Tanaka |
| author_facet | Koji Oba Nao Horie Norihiro Sato Kazuyoshi Saito Tsutomu Takeuchi Tsuneyo Mimori Nobuyuki Miyasaka Takao Koike Yoshiya Tanaka |
| author_sort | Koji Oba |
| collection | DOAJ |
| description | Infliximab, an inhibitor of TNF-α, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline serum TNF-α could be considered as a key indicator for optimal dosing of infliximab for RA treatment to achieve the clinical response and its sustained remission. The Remission induction by Raising the dose of Remicade in RA (RRRR) study is an open-label, parallel group, multicenter randomized controlled trial to compare the proportions of clinical remission based on the simplified disease activity index (SDAI) after 1 year of treatment and its sustained remission rate after another 1 year between the investigational treatment strategy (for which the dose of infliximab was chosen based on the baseline serum TNF) and the standard strategy of 3 mg/kg per 8 weeks of infliximab administration in infliximab-naïve patients with RA showing an inadequate response to MTX. The primary endpoint is the proportion of patients who kept discontinuation of infliximab 1 year after discontinued infliximab at the time of 54 weeks after the first administration of infliximab. The secondary endpoints are the proportion of clinical remission based on SDAI and changes in SDAI from baseline at each time point, other clinical parameters, quality of life measures and adverse events. Target sample size of randomized patients is 400 patients in total. The main results of the RRRR study are expected to be published at the end of 2017. |
| first_indexed | 2024-12-23T21:11:57Z |
| format | Article |
| id | doaj.art-3b99fa671fc54c44abba477d0e450632 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-23T21:11:57Z |
| publishDate | 2017-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-3b99fa671fc54c44abba477d0e4506322022-12-21T17:31:02ZengElsevierContemporary Clinical Trials Communications2451-86542017-12-018C495410.1016/j.conctc.2017.08.007Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritisKoji Oba0Nao Horie1Norihiro Sato2Kazuyoshi Saito3Tsutomu Takeuchi4Tsuneyo Mimori5Nobuyuki Miyasaka6Takao Koike7Yoshiya Tanaka8Interfaculty Initiative in Information Studies, Graduate School of Interdisciplinary Information Studies, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033 JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo, 060-8648 JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo, 060-8648 JapanFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, JapanDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 JapanDepartment of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, JapanDepartment of Rheumatology, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JapanNTT Sapporo Medical Center and Department of Medicine II, Hokkaido University Graduate School of Medicine, Minami 1, Nishi 15, Chuo-ku, Sapporo, 060-0061, JapanFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, JapanInfliximab, an inhibitor of TNF-α, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline serum TNF-α could be considered as a key indicator for optimal dosing of infliximab for RA treatment to achieve the clinical response and its sustained remission. The Remission induction by Raising the dose of Remicade in RA (RRRR) study is an open-label, parallel group, multicenter randomized controlled trial to compare the proportions of clinical remission based on the simplified disease activity index (SDAI) after 1 year of treatment and its sustained remission rate after another 1 year between the investigational treatment strategy (for which the dose of infliximab was chosen based on the baseline serum TNF) and the standard strategy of 3 mg/kg per 8 weeks of infliximab administration in infliximab-naïve patients with RA showing an inadequate response to MTX. The primary endpoint is the proportion of patients who kept discontinuation of infliximab 1 year after discontinued infliximab at the time of 54 weeks after the first administration of infliximab. The secondary endpoints are the proportion of clinical remission based on SDAI and changes in SDAI from baseline at each time point, other clinical parameters, quality of life measures and adverse events. Target sample size of randomized patients is 400 patients in total. The main results of the RRRR study are expected to be published at the end of 2017.http://www.sciencedirect.com/science/article/pii/S2451865417300819Rheumatoid arthritisInfliximabTNF-αRandomized controlled trialsSustained remissionProtocol paper |
| spellingShingle | Koji Oba Nao Horie Norihiro Sato Kazuyoshi Saito Tsutomu Takeuchi Tsuneyo Mimori Nobuyuki Miyasaka Takao Koike Yoshiya Tanaka Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis Contemporary Clinical Trials Communications Rheumatoid arthritis Infliximab TNF-α Randomized controlled trials Sustained remission Protocol paper |
| title | Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis |
| title_full | Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis |
| title_fullStr | Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis |
| title_full_unstemmed | Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis |
| title_short | Remission induction by Raising the dose of Remicade in RA (RRRR) study: Rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis |
| title_sort | remission induction by raising the dose of remicade in ra rrrr study rationale and study protocol for a randomized controlled trial comparing for sustained clinical remission after discontinuation of infliximab in patients with rheumatoid arthritis |
| topic | Rheumatoid arthritis Infliximab TNF-α Randomized controlled trials Sustained remission Protocol paper |
| url | http://www.sciencedirect.com/science/article/pii/S2451865417300819 |
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