Folic Acid ( DrugBank: Folic acid )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病2
46悪性関節リウマチ51
49全身性エリテマトーデス1
84サルコイドーシス2
296胆道閉鎖症1

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01238926
(ClinicalTrials.gov)
May 20089/11/2010Vitamin B6, B12, Folic Acid and Exercise in Parkinson's DiseaseEffects of Vitamin Supplementation and Strength Training in Parkinson's DiseaseParkinson's DiseaseDietary Supplement: PD vitamin supplementation;Other: PD exercise intervention;Other: PD vitamin + exerciseNew York Institute of TechnologyStony Brook UniversityActive, not recruiting50 Years80 YearsBoth40N/AUnited States
2NCT00853879
(ClinicalTrials.gov)
December 200626/2/2009An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's DiseaseAn Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's DiseaseParkinson's DiseaseDietary Supplement: Folic Acid, Vitamin B6, Vitamin B12;Dietary Supplement: B6, B12, L-methylfolate;Dietary Supplement: B6, B12, PlaceboNorth Shore Long Island Jewish Health SystemNULLTerminated30 YearsN/ABoth150N/AUnited States

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2200055292
2022-01-042022-01-05Correlation between the changes of serum cytokines and immune cell subsets levels and curative effect in patients with active rheumatoid arthritis before and after Yisaipu treatmentCorrelation between the changes of serum cytokines and immune cell subsets levels and curative effect in patients with active rheumatoid arthritis before and after Yisaipu treatment Rheumatoid ArthritisExperimental group:Yisaipu combined with methotrexate and folic acid;Peking University People's HospitalNULLRecruiting1865BothExperimental group:140;Phase 4China
2ITMCTR2100005379
2021-12-012021-12-06Clinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang PrescriptionClinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang Prescription RheumatismThe treatment group:Simiaoxiaoling Zhiwang Decoction (granule) + methotrexate + folic acid tablets;The control group:methotrexate + folic acid tablets;Yunnan Hospital of Traditional Chinese MedicineNULLRecruiting1870BothThe treatment group:36;The control group:36;China
3ChiCTR2100053999
2021-12-012021-12-06Clinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang PrescriptionClinical Study on Treatment of Damp Heat Stagnation Syndrome of Rheumatoid Arthritis by SiMiaoXiaoLing Zhiwang Prescription RheumatismExperimental group:Simiaoxiaoling Zhiwang Decoction (granule) + methotrexate + folic acid tablets;Control group:methotrexate + folic acid tablets;Yunnan Hospital of Traditional Chinese MedicineNULLRecruiting1870BothExperimental group:36;Control group:36;China
4ChiCTR2100054305
2021-12-012021-12-13Observation on the clinical efficacy of Jiawei Qianyang Fengsui Dan in the treatment of RA with mixed syndrome of cold and heatObservation on the clinical efficacy of Jiawei Qianyang Fengsui Dan in the treatment of RA with mixed syndrome of cold and heat Rheumatoid ArthritisTreatment group:Modified Qianyang Fengsui Dan + Methotrexate Tablets + Folic Acid Tablets;Control group:Methotrexate + Folic Acid;Yunnan Provincial Hospital of Traditional Chinese MedicineNULLRecruiting1870BothTreatment group:36;Control group:36;China
5ChiCTR2100042659
2021-01-252021-01-25Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulationObservation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation Rheumatoid Arthritisexperimental group:Fuzi Guizhi Decoction granules+Methotrexate tablets + Folic acid tablets;control group:Methotrexate tablets + Folic acid tablets;The Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1865Bothexperimental group:36;control group:36;China
6ITMCTR2100004321
2021-01-252021-01-25Observation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulationObservation on the clinical effect of treating rheumatoid arthritis based on the theory of kidney deficiency and cold coagulation Rheumatoid Arthritiscontrol group:Methotrexate tablets + Folic acid tablets;experimental group:Fuzi Guizhi Decoction granules+Methotrexate tablets + Folic acid tablets;The Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1865Bothcontrol group:36;experimental group:36;China
7ITMCTR2100004302
2021-01-212021-01-21Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance geneObservation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene difficult-to-treat rheumatoid arthritisThe normal group:No special treatment;Refractory (control group):Methotrexate + folic acid tablets + adalimumab + simulant;Refractory (trial group):Methotrexate + folic acid tablets + Adalimumab + Qingre Tongluo Prescription; Primary untreated group:Do not give any treatment, only before treatment for blood, the group does not consider follow-up treatment, recommended patients to seek medical advice, follow the doctor 's orders;Therapeutic effective group:Continue the original treatment plan;Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese MedicineNULLRecruiting1870BothThe normal group:15;Refractory (control group):15;Refractory (trial group):15; Primary untreated group:15;Therapeutic effective group:15;China
8ChiCTR2100042440
2021-01-212021-01-21Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance geneObservation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene difficult-to-treat rheumatoid arthritisThe normal group:No special treatment; Primary untreated group:Do not give any treatment, only before treatment for blood, the group does not consider follow-up treatment, recommended patients to seek medical advice, follow the doctor 's orders;Therapeutic effective group:Continue the original treatment plan;Refractory (trial group):Methotrexate + folic acid tablets + Adalimumab + Qingre Tongluo Prescription;Refractory (control group):Methotrexate + folic acid tablets + adalimumab + simulant;Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese MedicineNULLRecruiting1870BothThe normal group:15; Primary untreated group:15;Therapeutic effective group:15;Refractory (trial group):15;Refractory (control group):15;China
9ChiCTR2100042329
2021-01-192021-01-19Effect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolismEffect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolism rheumatoid arthritisIntervention group:Huangqijishengtang+Calcitriol Soft Capsules+MTX;Intervention group:Calcitriol Soft Capsules;Intervention group:MTX;Intervention group:Folic Acid;control group:Simulator of Huangqijishengtang;control group:Calcitriol Soft Capsules;control group:MTX;control group:Folic Acid;The Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1870BothIntervention group:38;Intervention group:38;Intervention group:38;Intervention group:38;control group:38;control group:38;control group:38;control group:38;China
10ITMCTR2100004290
2021-01-192021-01-19Effect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolismEffect of Huangqijishengtang on deficiency of liver and kidney in rheumatoid arthritis and its effect on bone metabolism rheumatoid arthritisIntervention group:Folic Acid;control group:Calcitriol Soft Capsules;Intervention group:Calcitriol Soft Capsules;control group:MTX;control group:Folic Acid;Intervention group:Huangqijishengtang+Calcitriol Soft Capsules+MTX;Intervention group:MTX;control group:Simulator of Huangqijishengtang;;12122112The Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1870BothIntervention group:38;control group:38;Intervention group:38;control group:38;control group:38;Intervention group:38;Intervention group:38;control group:38;China
11ITMCTR2100004288
2021-01-192021-01-19Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant GeneEffect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene Rheumatoid arthritisObservation group:Methotrexate + folic acid tablets + Adamumab + Wenyang Tongluo Recipient;Primary untreated group:No treatment was given, only blood was drawn before treatment, and follow-up treatment was not considered in this group. Patients were advised to seek medical treatment by themselves and follow the doctor's advice;Therapeutic effective group:Continue with the original regimen;The control group:Methotrexate + folic acid tablets + adamulizumab + simulation agent;The normal group:No special treatment will be given;Yunnan Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine)NULLRecruiting1870BothObservation group:15;Primary untreated group:15;Therapeutic effective group:15;The control group:15;The normal group:15;China
12ChiCTR2100042328
2021-01-192021-01-19Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant GeneEffect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene Rheumatoid arthritisThe normal group:No special treatment will be given;Primary untreated group:No treatment was given, only blood was drawn before treatment, and follow-up treatment was not considered in this group. Patients were advised to seek medical treatment by themselves and follow the doctor's advice;Therapeutic effective group:Continue with the original regimen;Observation group:Methotrexate + folic acid tablets + Adamumab + Wenyang Tongluo Recipient;The control group:Methotrexate + folic acid tablets + adamulizumab + simulation agent;Yunnan Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine)NULLRecruiting1870BothThe normal group:15;Primary untreated group:15;Therapeutic effective group:15;Observation group:15;The control group:15;China
13ITMCTR2100004638
2021-01-012021-01-06Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint painObservation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain Rheumatoid ArthritisControl group:Rebi cream simulant, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets;therapy group:Rebi ointment, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets ;Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1870BothControl group:36;therapy group:36;China
14ITMCTR2100004658
2021-01-012021-01-09Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and painObservation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pain Rheumatoid arthritistherapy group:Yiyisise ointment, Methotrexate, Leflunomide tablets and Folic acid tablets ;Control group:Yiyisise ointment simulant, Methotrexate, Leflunomide tablets and Folic acid tablets;Yunnan Hospital of Traditional Chinese MedicineNULLRecruitingBoththerapy group:36;Control group:36;China
15ChiCTR2100041894
2021-01-012021-01-09Observation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and painObservation on the clinical effect of external application of Yi medicine SISE ointment in the treatment of rheumatoid arthritis (wind cold dampness syndrome) joint swelling and pain Rheumatoid arthritistherapy group:Yiyisise ointment, Methotrexate, Leflunomide tablets and Folic acid tablets ;Control group:Yiyisise ointment simulant, Methotrexate, Leflunomide tablets and Folic acid tablets;Yunnan Hospital of Traditional Chinese MedicineNULLRecruitingBoththerapy group:36;Control group:36;China
16ITMCTR2100004637
2021-01-012021-01-06Clinical study of Hanbi ointment in the treatment of rheumatoid arthritisClinical study of Hanbi ointment in the treatment of rheumatoid arthritis Rheumatoid arthritisTreatment group:Hanbi ointment + Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;control group:Hanbi ointment simulant+ Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;The First Affiliated Hospital of Yunnan University of traditional Chinese MedicineNULLRecruitingBothTreatment group:36;control group:36;China
17ChiCTR2100041819
2021-01-012021-01-06Clinical study of Hanbi ointment in the treatment of rheumatoid arthritisClinical study of Hanbi ointment in the treatment of rheumatoid arthritis Rheumatoid arthritisTreatment group:Hanbi ointment + Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;control group:Hanbi ointment simulant+ Methotrexate + Leflunomide Tablets + Folic Acid Tablets ;The First Affiliated Hospital of Yunnan University of traditional Chinese MedicineNULLRecruitingBothTreatment group:36;control group:36;China
18ChiCTR2100041821
2021-01-012021-01-06Observation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint painObservation on the clinical curative effect of external application of Rebi ointment in treating rheumatoid arthritis (damp-heat syndrome) joint pain Rheumatoid Arthritistherapy group:Rebi ointment, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets ;Control group:Rebi cream simulant, Methotrexate tablets, Leflunomide tablets, and Folic acid tablets;Yunnan Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese MedicineNULLRecruiting1870Boththerapy group:36;Control group:36;China
19JPRN-jRCTs041200048
02/10/202002/10/2020Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-stateCertolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study Rheumatoid arthritis1) MTX*
- Continued group:
Continued at a stable dose and interval throughout the cours of the study.
Folic acid is continued if concomitantly used.
- Withdrawn group:
Week 0 to 12
Reduced after registration.
The dose of MTX is reduced to half, regardless of the initial dose.
Folic acid is continued if concomitantly used.
Week 12 to 52
Discontinued if low disease activity was maintained.
Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) CZP and csDMARDs other than MTX
Continued at a stable dose and interval throughout the course of the study in both groups.

3) Glucocorticoids
Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group.

4) Rescue treatment
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request.
- Restoring, restarting, or increasing doses of MTX
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Asai ShujiKojima ToshihisaRecruiting>= 20age oldNot applicableBoth114N/AJapan
20JPRN-jRCT1041190125
09/03/202009/03/2020PRECIOUS-B studyPatient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study Rheumatoid arthritis1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used.
Week 12 to 52
- Discontinued if low disease activity was maintained.
- Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request
- Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX.
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids.
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Asai ShujiNULLRecruiting>= 20age oldNot applicableBoth51N/AJapan
21NCT04066803
(ClinicalTrials.gov)
August 1, 201811/12/2018Optimal MTX Dose With Folic Acid Randomized Case-control TrialSafety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control StudyRheumatoid ArthritisDrug: MTX;Drug: Folic Acid;Drug: DMARDsSun Yat-sen UniversityShanghai Pharmaceuticals Holding Co., LtdRecruiting18 Years70 YearsAll160Phase 4China
22JPRN-jRCT1031180088
18/04/201818/01/2019MIRACLE StudyMIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study Rheumatoid Arthritis
Rheumatoid Arthritis
Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period).
To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle.
If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1).
If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3).
The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week.
Subjects in whom MTX at a dosage >=
Kaneko YukoEisai Co., Ltd.Complete>= 18age oldNot applicableBoth300Phase 4South Korea;Taiwan;Japan
23NCT02795299
(ClinicalTrials.gov)
January 20182/5/2016Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid ArthritisPhase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa AntagonistRheumatoid ArthritisDrug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: PlaceboBird Rock Bio, Inc.Techtrials Pesquisa e Tecnologia Ltda;PharmagenixWithdrawn18 Years80 YearsAll0Phase 2NULL
24NCT03028467
(ClinicalTrials.gov)
January 24, 201710/1/2017Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid ArthritisA Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With MethotrexateArthritis, RheumatoidDrug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acidGlaxoSmithKlineNULLCompleted20 YearsN/AAll15Phase 1/Phase 2Japan
25NCT02833350
(ClinicalTrials.gov)
September 9, 201612/7/2016Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2)Rheumatoid ArthritisDrug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: PlaceboGenentech, Inc.NULLCompleted18 Years75 YearsAll578Phase 2United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile
26NCT02930343
(ClinicalTrials.gov)
September 201613/9/2016Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate MonotherapyComparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control TrialRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: SulfasalazineJawaharlal Institute of Postgraduate Medical Education & ResearchNULLTerminated18 Years65 YearsAll136Phase 3India
27NCT02762838
(ClinicalTrials.gov)
January 20164/4/2016Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisInternational Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acidBiocadNULLCompleted18 Years75 YearsAll426Phase 3Belarus;India;Russian Federation
28NCT02644499
(ClinicalTrials.gov)
December 31, 201530/12/2015Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid ArthritisComparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic AcidJawaharlal Institute of Postgraduate Medical Education & ResearchNULLCompleted18 YearsN/AAll186Phase 4India
29NCT03172325
(ClinicalTrials.gov)
November 18, 201524/5/2017Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RAA Phase III, Randomized, Two-armed, Double-blind, Parallel, Active Controlled Clinical Trial to Determine the Non-inferior Efficacy and Safety of CinnoRA® (Adalimumab, CinnaGen Co.) Versus Humira® for Treatment of Active RAActive Rheumatoid ArthritisDrug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: PrednisoloneCinnagenNULLCompleted18 Years75 YearsAll136Phase 3Iran, Islamic Republic of
30NCT02504671
(ClinicalTrials.gov)
July 23, 201520/7/2015Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid ArthritisA Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination With Methotrexate Therapy, in Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With MethotrexateArthritis, RheumatoidDrug: GSK3196165;Drug: MTX;Drug: Folic acid;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll222Phase 2Bulgaria;Canada;Czechia;Estonia;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
31NCT02467504
(ClinicalTrials.gov)
July 1, 20154/6/2015Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid ArthritisA Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: hrIL-2 active;Drug: hrIL-2 placebo;Drug: MTX;Drug: Folic Acid;Drug: LoxoprofenPeking University People's HospitalMonash University;Beijing ShuangLu Pharmaceutical Co., Ltd.Completed18 Years70 YearsAll47Phase 2China
32NCT02393378
(ClinicalTrials.gov)
April 8, 201515/3/2015Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to MethotrexateA 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to MethotrexateRheumatoid ArthritisDrug: Namilumab;Drug: Adalimumab;Drug: Methotrexate;Drug: Folic AcidTakedaNULLTerminated18 YearsN/AAll7Phase 2Czechia;Estonia;Russian Federation;Spain;United Kingdom;Czech Republic
33NCT02373813
(ClinicalTrials.gov)
February 20, 201512/1/2015Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis RemissionA Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: etanercept pre-filled syringe subcutaneous injection;Drug: Oral methotrexate;Drug: Placebo for etanercept subcutaneous injection;Drug: Placebo for methotrexate;Dietary Supplement: Folic acid (non-investigational product)AmgenNULLCompleted18 YearsN/AAll371Phase 3United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic
34JPRN-JapicCTI-152979
01/2/2015Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Rheumatoid ArthritisIntervention name : Namilumab
Dosage And administration of the intervention : Namilumab 20 mg, 80 mg or 150 mg subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Namilumab placebo-matching SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.
TAKEDA PHARMACEUTICAL COMPANY LTD.NULL20BOTH108Phase 2NULL
35NCT02293902
(ClinicalTrials.gov)
November 201413/11/2014A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX TherapyRheumatoid ArthritisDrug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acidSanofiRegeneron PharmaceuticalsCompleted20 Years75 YearsAll243Phase 3Japan
36NCT01873443
(ClinicalTrials.gov)
May 201322/5/2013Long-Term Efficacy and Safety of CT-P10 in Patients With RAAn Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1Rheumatoid ArthritisDrug: Rituximab, MTX, folic acidCelltrionNULLCompleted18 Years75 YearsBoth87Phase 1Korea, Republic of
37NCT01850680
(ClinicalTrials.gov)
April 20131/5/2013Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant MethotrexateRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: placebo;Drug: methotrexate;Drug: folic acidSanofiRegeneron PharmaceuticalsCompleted20 Years65 YearsBoth61Phase 1Japan
38NCT01711359
(ClinicalTrials.gov)
November 201218/10/2012A Study in Participants With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic AcidEli Lilly and CompanyNULLCompleted18 YearsN/AAll588Phase 3United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom
39NCT01583959
(ClinicalTrials.gov)
April 201215/3/2012Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid ArthritisRandomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid ArthritisRheumatoid ArthritisDrug: Folic Acid;Drug: PlaceboPostgraduate Institute of Medical Education and ResearchNULLCompleted18 Years75 YearsBoth100Phase 4India
40EUCTR2010-019134-27-BG
(EUCTR)
23/12/201018/10/2010A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPYA PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY Rhuematoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate 10 mg tablets
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folimet
Product Name: Folic Acid
INN or Proposed INN: Folic Acid
Chelsea Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Czech Republic;Mexico;Argentina;Poland;Bulgaria
41EUCTR2010-019134-27-CZ
(EUCTR)
19/10/201028/06/2010A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPYA PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY Rhuematoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folic Acid
Product Name: Folic Acid
INN or Proposed INN: Folic Acid
Chelsea Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Bulgaria
42NCT01116141
(ClinicalTrials.gov)
September 20103/5/2010A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX MonotherapyRheumatoid ArthritisDrug: CH-4051;Drug: Methotrexate (MTX);Drug: Folic AcidChelsea TherapeuticsNULLCompleted18 Years80 YearsBoth250Phase 2NULL
43NCT01061736
(ClinicalTrials.gov)
March 20102/2/2010Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis PatientsA Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX TherapyRheumatoid ArthritisDrug: Sarilumab;Drug: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic AcidSanofiRegeneron PharmaceuticalsCompleted18 Years75 YearsAll1675Phase 2/Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;Chile;Colombia;Czechia;Egypt;Estonia;Finland;Germany;Greece;Hungary;India;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Philippines;Poland;Portugal;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;Czech Republic
44NCT01010581
(ClinicalTrials.gov)
November 20099/11/2009SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid ArthritisA Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: SC12267 (4SC-101);Drug: Placebo;Drug: Methotrexate;Drug: Folic Acid4SC AGNULLCompleted18 YearsN/ABoth266Phase 2Bulgaria;Czech Republic;Poland;Romania
45NCT00965653
(ClinicalTrials.gov)
August 200918/8/2009A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid ArthritisOpen-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: folic acid;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 Years75 YearsBoth29Phase 1Canada;New Zealand;Spain;United Kingdom
46NCT00578305
(ClinicalTrials.gov)
November 200719/12/2007A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to MethotrexateA Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisBiological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folateHoffmann-La RocheNULLCompleted18 Years80 YearsAll185Phase 3Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom
47NCT01308255
(ClinicalTrials.gov)
September 20063/3/2011Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.Rheumatoid ArthritisDrug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acidUniversity of LeedsNULLCompleted18 Years80 YearsAll112Phase 4United Kingdom
48EUCTR2005-005013-37-GB
(EUCTR)
06/04/200620/01/2006A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEAA multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA Early Rheumatoid ArthritisTrade Name: Remicade
Product Name: Remicade
Product Code: Infliximab
Trade Name: Mextrex
Product Name: Methotrexate
Product Code: Mextrex
INN or Proposed INN: n/a
Other descriptive name: Methotrexate
Trade Name: Ferrograd Folic Tablets
Product Name: Folic Acid
Product Code: Ferrograd
INN or Proposed INN: n/a
Other descriptive name: Folic Acid
Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
INN or Proposed INN: n/a
Other descriptive name: Methylprednisolone
Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
INN or Proposed INN: n/a
University of LeedsNULLNot Recruiting Female: yes
Male: yes
112 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
49EUCTR2005-000551-15-GB
(EUCTR)
05/09/200505/08/2005Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexateEffect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients.Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction. Product Name: Allopurinol
Product Code: Allopurinol
INN or Proposed INN: Allopurinol
Product Name: Folic acid
Product Code: Folic acid
INN or Proposed INN: Folic acid
University of DundeeNULLNot RecruitingFemale: yes
Male: yes
Phase 4United Kingdom
50NCT02093026
(ClinicalTrials.gov)
August 200219/3/2014Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic AcidHoffmann-La RocheGenentech, Inc.Completed21 YearsN/AAll465Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom
51NCT00000395
(ClinicalTrials.gov)
September 19963/11/1999Antifolate Effectiveness in ArthritisMechanisms of Antifolate Efficacy in ArthritisRheumatoid Arthritis;Adjuvant ArthritisDrug: Methotrexate;Dietary Supplement: Folinic acid;Dietary Supplement: Folic acidUniversity of Alabama at BirminghamNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Dietary Supplements (ODS)Completed18 Years85 YearsBoth40Phase 2United States

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00470522
(ClinicalTrials.gov)
June 19952/5/2007Study of Methotrexate in Lupus ErythematosusA Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial.Systemic Lupus ErythematosusDrug: Methotrexate and folic acidUniversity Health Network, TorontoMcGill University Health CenterCompleted18 YearsN/ABoth86Phase 3Canada

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs011210048
05/11/202105/11/2021Cardiac Sarcoidosis Multi-Center Randomized Controlled TrialCardiac Sarcoidosis Multi-Center Randomized Controlled Trial - CHASM CS- RCT Cardiac Sarcoidosis
Cardiac Sarcoidosis
Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either:

1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or

2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP
Toshiyuki NagaiNULLPending>= 18age oldNot applicableBoth194Phase 3Canada;United States;United Kingdom;Japan
2JPRN-jRCTs041180111
16/12/201619/03/2019Estimated by FDG PET/CT in Myocardial SarcoidosisOptimal Medical Therapy Estimated by FDG PET/CT in Myocardial Sarcoidosis - OMT-CS study Cardiac sarcoidosis
Cardiac sarcoidosis
After using PSL for 6 months, patients were classified by decreasing rate of TLG. If TLG is decreasing over 70%, PSL was prescribed 5mg/day for more 6 months. If TLG is decreasing under 70%, arm A: PSL was prescribed 30mg/day and diminishing PSL 5mg per month for more 6 months arm B: MTX (6mg/week) and folic acid (5mg/week) was prescribed for more 6 monthsMurohara ToyoakiNULLComplete>= 20age oldNot applicableBoth85Phase 3Japan

296. 胆道閉鎖症


臨床試験数 : 71 薬物数 : 70 - (DrugBank : 39) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 60
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100050992
2021-10-082021-09-10Treatment of biliary atresia and prevention of postoperative cholangitis with folic acid: Multicenter clinical study on drug efficacyTherapeutic and preventive effect of Folic acid on billiary atresia and postoperative cholangitis biliary atresiacontrol group:Conventional therapy;experimental group:Conventional therapy+Folic acid;Guangzhou Women and Children Medical CenterNULLRecruiting02Bothcontrol group:150;experimental group:150;China