46. 悪性関節リウマチ
[臨床試験数:4,183,薬物数:2,538(DrugBank:401),標的遺伝子数:183,標的パスウェイ数:219

Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
40 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03938701
(ClinicalTrials.gov)
March 202125/2/2019Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis Using the Fluorescent Tracer OTL38 Targeting the Folate ß Receptor: a Single-center Pilot StudyIBD;Rheumatoid ArthritisDrug: OTL38;Device: Fluorescence ImagingUniversity Medical Center GroningenGlaxoSmithKline;On Target Laboratories, LLC;VU University Medical CenterNot yet recruiting18 YearsN/AAll30Phase 1Netherlands
2JPRN-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.
Takahashi NobunoriNULLPending>= 20age oldNot applicableBoth51N/AJapan
3EUCTR2018-004429-94-NL
(EUCTR)
21/01/202017/06/2019Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan.[18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: [18F]PEG-FolateVU Medical Center, department of RheumatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 4Netherlands
4NCT04066803
(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
5JPRN-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.Not Recruiting>= 18age oldNot applicableBoth300Phase 4South Korea;Taiwan;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02795299
(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
7NCT03028467
(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
8NCT02833350
(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
9NCT02930343
(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 & ResearchNULLCompleted18 Years65 YearsAll136Phase 3India
10NCT02762838
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02644499
(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
12NCT03172325
(ClinicalTrials.gov)
November 18, 201524/5/2017Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid ArthritisA Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid ArthritisActive Rheumatoid ArthritisDrug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: PrednisoloneCinnagenNULLCompleted18 Years75 YearsAll136Phase 3NULL
13NCT02504671
(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
14NCT02467504
(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
15NCT02393378
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16JPRN-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
17NCT02293902
(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
18NCT01873443
(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
19NCT01850680
(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
20NCT01711359
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01583959
(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
22NCT01283971
(ClinicalTrials.gov)
May 201125/1/2011A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-InhibitorA Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF InhibitorRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folateHoffmann-La RocheNULLTerminated18 YearsN/AAll96Phase 4United States;Denmark;Finland;France;Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;United Kingdom
23EUCTR2010-019134-27-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
24EUCTR2010-019134-27-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
25NCT01116141
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01061736
(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
27NCT01010581
(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
28NCT00965653
(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
29NCT00578305
(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
30NCT00462345
(ClinicalTrials.gov)
June 200718/4/2007A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF TherapiesRheumatoid ArthritisDrug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: FolateHoffmann-La RocheNULLCompleted18 Years80 YearsAll40Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT01308255
(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
32NCT00588393
(ClinicalTrials.gov)
September 200622/12/2007FolateScan in Autoimmune DiseaseStudy of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory DiseasesRheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus ErythematosusDrug: FolateScan (Technetium Tc 99mEC20)Mayo ClinicEndocyteCompleted18 YearsN/ABoth75Phase 2United States
33NCT00298272
(ClinicalTrials.gov)
May 20061/3/2006Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid ArthritisA Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid ArthritisRheumatoid ArthritisBiological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: FolateBiogenHoffmann-La Roche;Genentech, Inc.Terminated18 Years65 YearsAll54Phase 2United States
34NCT00299104
(ClinicalTrials.gov)
January 20062/3/2006A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid ArthritisA Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximabGenentech, Inc.Hoffmann-La RocheCompleted18 Years80 YearsAll755Phase 3United States
35NCT00266227
(ClinicalTrials.gov)
January 200614/12/2005A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background MethotrexateA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisDrug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folateGenentech, Inc.NULLCompleted18 Years80 YearsAll559Phase 3United States
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
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PhaseCountries
36NCT00299130
(ClinicalTrials.gov)
October 20053/3/2006A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid ArthritisA Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Folate;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Placebo;Drug: RituximabGenentech, Inc.Hoffmann-La RocheCompleted18 Years80 YearsAll511Phase 3United States
37EUCTR2005-000551-15-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
38NCT00243412
(ClinicalTrials.gov)
August 200521/10/2005A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving MethotrexateA Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of MethotrexateRheumatoid ArthritisDrug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: RituximabGenentech, Inc.NULLCompleted18 Years65 YearsAll42Phase 2United States
39NCT02093026
(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
40NCT00000395
(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