46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
|February 13, 2019||8/11/2018||A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)||Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial||Rheumatoid Arthritis (RA)||Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept||Astellas Pharma Korea, Inc.||NULL||Completed||19 Years||75 Years||All||21||Phase 4||Korea, Republic of|
|February 2015||12/2/2015||A 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 Arthritis||Rheumatoid Arthritis||Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine||Sanofi||Regeneron Pharmaceuticals||Completed||20 Years||N/A||All||91||Phase 3||Japan|
|January 2015||13/7/2016||The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment||Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China||Arthritis, Rheumatoid||Drug: Tacrolimus;Drug: MTX||Qiang Shu||NULL||Recruiting||18 Years||80 Years||All||150||Phase 4||China|
|4||JPRN-UMIN000013546||2014/06/01||31/03/2014||The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus||rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis||take a glass of grapefruit juice every day|
do not take grapefruit juice
|Department of Rheumatology and Clinical Immunology, Kyoto University Hospital||NULL||Pending||16years-old||80years-old||Male and Female||20||Not applicable||Japan|
|5||JPRN-UMIN000010126||2013/02/25||26/02/2013||Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease||Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD||Interstitial lung disease related to rheumatoid arthritis||In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on.|
In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.
|Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University||NULL||Complete: follow-up complete||20years-old||Not applicable||Male and Female||34||Not applicable||Japan|
|August 2012||4/6/2013||Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients||Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings||Rheumatoid Arthritis||Drug: tacrolimus;Drug: biological agents||Astellas Pharma Inc||NULL||Completed||N/A||N/A||Both||664||N/A||Japan|
|August 2012||4/12/2012||Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis||Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis||Rheumatoid Arthritis||Drug: Tacrolimus with Methotrexate||Chong Kun Dang Pharmaceutical||NULL||Completed||20 Years||N/A||Both||111||Phase 4||Korea, Republic of|
|8||JPRN-UMIN000008572||2012/07/31||31/07/2012||The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients||Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX)||Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks.|
Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 weeks.
|Department of Rheumatology and infectious disease, Kitasato university school of medicine||1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicine clinic||Recruiting||20years-old||70years-old||Male and Female||80||Not applicable||Japan|
|9||JPRN-UMIN000007205||2012/02/01||02/02/2012||The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis||Rheumatoid arthritis||1) Tacrolimus|
Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained.
The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on.
However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects.
|Juntendo University||NULL||Pending||65years-old||Not applicable||Male and Female||30||Not selected||Japan|
|10||JPRN-UMIN000006702||2012/02/01||11/11/2011||A 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 arthritis||Intensive 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 University||Department of Pharmacovigilance||Complete: follow-up continuing||20years-old||70years-old||Male and Female||290||Not applicable||Japan|
|December 5, 2011||4/1/2012||A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)||An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs||Rheumatoid Arthritis||Drug: Tacrolimus||Astellas Pharma Inc||Astellas Pharma Korea, Inc.||Completed||20 Years||75 Years||All||128||Phase 4||Korea, Republic of|
|August 2009||18/10/2010||Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate||Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study||Rheumatoid Arthritis||Drug: Tacrolimus||Astellas Pharma Inc||Astellas Pharma Korea, Inc.||Completed||18 Years||75 Years||Both||78||Phase 4||Korea, Republic of|
|May 2008||14/10/2010||A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate||Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study||Rheumatoid Arthritis||Drug: Tacrolimus||Astellas Pharma Inc||Astellas Pharma Korea, Inc.||Completed||18 Years||75 Years||Both||50||Phase 4||Korea, Republic of|
|14||JPRN-UMIN000000512||2006/10/01||03/11/2006||Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate||Rheumatoid Arthritis||If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks.|
If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.
|Rheumatosurgery, Osaka City University Medical School||NULL||Complete: follow-up complete||Not applicable||Not applicable||Male and Female||30||Not applicable||Japan|
|April 2006||27/4/2006||A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients||FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients||Rheumatoid Arthritis||Drug: tacrolimus;Drug: placebo||Astellas Pharma Inc||NULL||Completed||20 Years||64 Years||Both||123||Phase 4||Japan|
|March 2002||8/5/2002||Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis||A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate||Rheumatoid Arthritis||Drug: Tacrolimus (Prograf®);Drug: Methotrexate||Astellas Pharma Inc||Astellas Pharma US, Inc.||Completed||18 Years||N/A||Both||210||Phase 3||United States;Canada|