Tacrolimus with Methotrexate
( DrugBank: Tacrolimus / KEGG DRUG: Tacrolimus, Tacrolimus )
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 | 7 |
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
Showing 1 to 7 of 7 trials
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03737708 (ClinicalTrials.gov) | February 13, 201920190213 | 8/11/201820181108 | A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) A Study Comparing Biologics + Methotrexate WithBiologics + Tacrolimusin Patients WithRheumatoid Arth ... | 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 Compare Efficacy and Safety Between Biologics + Methotrexate(MTX) vs Biologics + Tacrolimus(TAC) (Sw ... | Rheumatoid Arthritis (RA) | Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abata ... | Astellas Pharma Korea, Inc. | NULL | Completed | 19 Years | 75 Years | All | 21 | Phase 4 | Korea, Republic of |
| 2 | JPRN-UMIN000010126 | 2013/02/2520130225 | 26/02/201320130226 | 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 withmoderate doses of corticosteroid and immunosuppressants in rheu ... | 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 Efficacy and safety of treatment withmoderate doses of corticosteroid and immunosuppressants in rheu ... | 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. In cases withUIP/NSIP pattern ILD, treatment is started withprednisolone and tacrolimus. For safety ... | 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 |
| 3 | NCT01746680 (ClinicalTrials.gov) | August 201220120800 | 4/12/201220121204 | 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 |
| 4 | JPRN-UMIN000008572 | 2012/07/3120120731 | 31/07/201220120731 | The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus,the combined therapy with M ... | The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients - K-NET study: The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus,the combined therapy with M ... | 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. Tacrolimusgroup patients receive daily the optimal dosage of tacrolimus within the range between 1.5 ... | Department of Rheumatology and infectious disease, Kitasato university school of medicine | 1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicine clinic 1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicin ... | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 80 | Not applicable | Japan |
| 5 | JPRN-UMIN000007205 | 2012/02/0120120201 | 02/02/201220120202 | The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis The efficacy and safety of adding tacrolimusto methotrexatein elderly patients withrheumatoid arthri ... | The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis - The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis The efficacy and safety of adding tacrolimusto methotrexatein elderly patients withrheumatoid arthri ... | 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. 1) Tacrolimus Oral administration of tacrolimusis started usually at a dose of 1.5 mg/day immediately ... | Juntendo University | NULL | Pending | 65years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 6 | JPRN-UMIN000000512 | 2006/10/0120061001 | 03/11/200620061103 | Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate Efficacy of tacrolimusin rheumatoid arthritis patients who have been treated unsuccessfully withinfl ... | Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate - Combination therapy with Methotrexate, Infliximab, and Tacrolimus (COMMIT project) Efficacy of tacrolimusin rheumatoid arthritis patients who have been treated unsuccessfully withinfl ... | 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. If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and ... | Rheumatosurgery, Osaka City University Medical School | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 30 | Not applicable | Japan |
| 7 | NCT00036153 (ClinicalTrials.gov) | March 200220020300 | 8/5/200220020508 | Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis Study to Assess Efficacy of Tacrolimus+ MethotrexateVersus Placebo + Methotrexatein Treatment of Rhe ... | 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 A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus(Prograf®)+ MethotrexateVs. Pla ... | 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 |