Bucillamine ( DrugBank: Bucillamine )

1 disease
告示番号疾患名（ページ内リンク）臨床試験数
46悪性関節リウマチ9

46. 悪性関節リウマチ

臨床試験数 : 4,325 /  薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT02373202
(ClinicalTrials.gov)		February 201512/2/2015A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: MizoribineSanofiRegeneron PharmaceuticalsCompleted20 YearsN/AAll91Phase 3Japan
2JPRN-UMIN000012690
2013/12/2827/12/2013Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment Rheumatoid Arthritistocilizumab+tacrolimus+Bucillamine
tocilizumab		National hospital organization Chiba east national hospital Clinical Research CenterNULLComplete: follow-up complete20years-old99years-oldMale and Female60Not applicableJapan
3JPRN-UMIN000007404
2013/01/0101/03/2012Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate. Rheumatoid arthritisDose escalation of methotrexate
Concomitant therapy of methotrexate and bucillamine		KONAMON Study GroupNULLRecruitingNot applicableNot applicableMale and Female90Not applicableJapan
4JPRN-UMIN000006702
2012/02/0111/11/2011A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis rheumatoid arthritisIntensive treatment group
Period: 24 weeks
In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol.
After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Conventional treatment group
Period: 24 weeks
In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.		Tokyo Medical and Dental UniversityDepartment of PharmacovigilanceComplete: follow-up continuing20years-old70years-oldMale and Female290Not applicableJapan
5JPRN-UMIN000003807
2010/07/0101/07/2010A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis Rheumatoid ArthritisCombination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Combination therapy of TNF-bloking biologics and methotrexate		Japan Association of Rheumatologists in Private PracticeNULLComplete: follow-up completeNot applicableNot applicableMale and Female160Not applicableJapan
6JPRN-UMIN000003615
2010/05/0114/05/2010Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA RA(Rheumatoid Arthritis)Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 monthsSt Luke's International HospitalNULLRecruiting20years-old80years-oldMale and Female20Not selectedJapan
7JPRN-UMIN000002169
2009/07/0107/07/2009Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis Rheumatoid ArthritisSalazosulfapyridine
Bucillamine		Higashi-Hiroshima Memorial HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female60Phase 4Japan
8JPRN-UMIN000000837
2007/10/0101/10/2007Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study Rheumatoid arthritisBucillamine mono-therapy(It's possible to choose the combination therapy with salazosulphapyridine at 6 months after the start of the treatment)
Salazosulphapyridine mono-therapy(It's possible to choose the combination therapy with bucillamineat 6 months after the start of the treatment)
Combination therapy of bucillamine and salazosulphapyridine (over the study period)		BASIC study groupNULLRecruiting20years-old75years-oldMale and Female180Not applicableJapan
9NCT00716248
(ClinicalTrials.gov)		January 20078/7/2008Bucillamine Study of Holding Remission After Infliximab Dose-offThe Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving MethotrexateRheumatoid ArthritisDrug: bucillamine;Drug: methotrexateSaitama Medical UniversityKeio UniversityActive, not recruiting20 YearsN/ABoth40Phase 4Japan

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