46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
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. | 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 | NCT05606107 (ClinicalTrials.gov) | May 20, 2022 | 1/11/2022 | To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks | To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: Glucocorticoid | Second Affiliated Hospital, School of Medicine, Zhejiang University | Jiaxing Hospital of T.C.M;Jinhua Municipal Central Hospital;SAHZU.CHANGXING CAMPUS;Zhuji People's hospital;Shaoxing People's Hospital | Recruiting | 18 Years | 70 Years | All | 230 | Phase 4 | China |
| 2 | JPRN-jRCTs041200048 | 02/10/2020 | 02/10/2020 | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study | Rheumatoid arthritis | 1) 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 - Withdrawn group: Week 0 to 12 Reduced after registration.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 Shuji | Kojima Toshihisa | Recruiting | >= 20age old | Not applicable | Both | 114 | N/A | Japan |
| 3 | ChiCTR2000033004 | 2020-06-01 | 2020-05-17 | Clinical study of intravenous lidocaine infusion in patients with rheumatoid arthritis | Clinical study of intravenous lidocaine infusion in patients with rheumatoid arthritis | Rheumatoid arthritis | Group 1:glucocorticoid;Group 2:intravenous lidocaine infusion and glucocorticoid;Group 3:intravenous lidocaine infusion;Group 4:NSAIDS; | Department of Pain, Guizhou Provincial People's Hospita | NULL | Pending | 18 | 65 | Both | Group 1:30;Group 2:30;Group 3:30;Group 4:30; | China | |
| 4 | JPRN-jRCT1041190125 | 09/03/2020 | 09/03/2020 | PRECIOUS-B study | Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study | Rheumatoid arthritis | 1) 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 Shuji | NULL | Recruiting | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 5 | NCT02418273 (ClinicalTrials.gov) | August 1, 2019 | 6/4/2015 | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study | Osteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced Osteoporosis | Drug: denosumab | Indiana University | NULL | Withdrawn | 4 Years | 16 Years | All | 0 | Phase 1/Phase 2 | United States |
| 6 | EUCTR2017-004054-41-BE (EUCTR) | 07/05/2018 | 15/03/2018 | COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA | CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020 | early active Rheumatoid Arthritis, previously untreated with DMARDs MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: etanercept INN or Proposed INN: ETANERCEPT INN or Proposed INN: LEFLUNOMIDE | University Hospitals Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Belgium | ||
| 7 | EUCTR2017-003425-15-DK (EUCTR) | 10/11/2017 | 12/09/2017 | Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian) | Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian) | Treatment of synovitis among rheumatoid arthritis patients MedDRA version: 21.0;Level: PT;Classification code 10042868;Term: Synovitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Diprofos Depot INN or Proposed INN: BETAMETHASONE ACIBUTATE Other descriptive name: Binyrebsrkhormon | Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Denmark | ||
| 8 | NCT03291457 (ClinicalTrials.gov) | March 30, 2017 | 20/9/2017 | A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice | A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Glucocorticoid Agent | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 101 | Belgium | |
| 9 | ChiCTR-IPR-17010325 | 2017-01-31 | 2017-01-04 | The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial | The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial | rheumatic disease;M05.901 | Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | NULL | Pending | 18 | 65 | Both | Metformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100; | China | |
| 10 | NCT02997605 (ClinicalTrials.gov) | January 31, 2017 | 15/12/2016 | Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients | Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission. | RheumatoId Arthritis | Drug: GlucoCorticoid | University Hospital, Toulouse | NULL | Completed | 18 Years | N/A | All | 102 | Phase 4 | France |
| 11 | ChiCTR-IPR-17010307 | 2017-01-01 | 2017-01-01 | The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China | Rheumatoid Arthritis;M05.901 | Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | NULL | Recruiting | 18 | 65 | Both | Rapamycin group:200;Non-rapamycin group :100; | China | |
| 12 | NCT02982083 (ClinicalTrials.gov) | December 2016 | 1/12/2016 | Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis | Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Raloxifene hydrochloride;Drug: Placebo Oral Tablet | Sara Saeidi Shahri | NULL | Not yet recruiting | 50 Years | N/A | Female | 40 | N/A | NULL |
| 13 | JPRN-jRCTs041180071 | 13/10/2016 | 07/03/2019 | T-ReX study | Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study | Rheumatoid arthritis | At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were 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 or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Kojima Toshihisa | NULL | Complete | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 14 | EUCTR2015-002729-21-PT (EUCTR) | 12/09/2016 | 27/04/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 15 | EUCTR2016-001618-18-FR (EUCTR) | 08/07/2016 | 09/06/2016 | Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients | STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR | glucocorticoid withdrawal in rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisone Product Name: prednisone 5 mg Trade Name: Prednisone Product Name: prednisone 4 mg Trade Name: Prednisone Product Name: prednisone 3 mg Trade Name: Prednisone Product Name: prednisone 2 mg Trade Name: Prednisone Product Name: prednisone 1 mg Trade Name: Hydrocortisone 10mg | CHU Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 4 | France | ||
| 16 | NCT02585258 (ClinicalTrials.gov) | June 30, 2016 | 20/10/2015 | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis | RheumatoId Arthritis | Drug: Prednisolone;Other: Placebo | VU University Medical Center | European Commission | Completed | 65 Years | N/A | All | 451 | Phase 4 | Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia;Finland |
| 17 | EUCTR2015-002729-21-FI (EUCTR) | 21/06/2016 | 30/03/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 18 | EUCTR2015-002729-21-HU (EUCTR) | 04/05/2016 | 11/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 19 | EUCTR2015-002729-21-DE (EUCTR) | 25/04/2016 | 02/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - GLORIA | Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 20 | EUCTR2015-002729-21-SK (EUCTR) | 22/04/2016 | 25/02/2016 | A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis | The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria | Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 4 | Portugal;Hungary;Slovakia;Finland;Germany | ||
| 21 | NCT02573012 (ClinicalTrials.gov) | March 29, 2016 | 1/10/2015 | Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants | Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Placebo matched to prednisone;Drug: Prednisone;Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 314 | Phase 4 | France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey |
| 22 | EUCTR2014-004673-16-DE (EUCTR) | 12/01/2016 | 15/07/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: RoActemra Product Code: L04AC07 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland | ||
| 23 | NCT02878161 (ClinicalTrials.gov) | January 2016 | 12/7/2016 | Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World | Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway | Rheumatoid Arthritis | Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary) | Fen Li | NULL | Enrolling by invitation | 18 Years | 75 Years | Both | 240 | Phase 4 | NULL |
| 24 | EUCTR2014-004673-16-FR (EUCTR) | 16/11/2015 | 05/08/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland | ||
| 25 | EUCTR2014-004673-16-IT (EUCTR) | 27/07/2015 | 04/06/2021 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | PROSPECTIVE, MULTICENTRE, PLACEBO CONTROLLED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY OF MAINTENANCE TREATMENT WITH TOCILIZUMAB WITH OR WITHOUT GLUCOCORTICOID DISCONTINUATION IN RHEUMATOID ARTHRITIS PATIENTS - NA | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE Product Name: NA Product Code: RO487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton, 5 mg, tablets INN or Proposed INN: PREDNISONE | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | France;Serbia;Egypt;Lebanon;Turkey;Russian Federation;Germany;Switzerland;Italy | ||
| 26 | EUCTR2014-000993-20-SE (EUCTR) | 04/12/2014 | 02/09/2014 | Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseases | Dosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritis | Psoriatic arthritis and rheumatoid arthritis with synovitis of the knee;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: triamcinolone hexacetonide (Lederspan) Product Name: triamcinolone hexacetonid (Lederspan) Product Code: 9512 Trade Name: triamcinolone hexacetonide (Lederspan) Product Name: triamcinolone hexacetonid (Lederspan) Product Code: 9512 | Center for Research and Development Uppsala University/County Council of Gävleborg | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Sweden | ||
| 27 | ChiCTR1900026116 | 2014-06-01 | 2019-09-22 | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | rheumatoid arthritis | Experimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine; | Central Hospital of Jinhua | NULL | Completed | 21 | 73 | Both | Experimental group:40;control group:40; | Phase 4 | China |
| 28 | EUCTR2013-003486-34-DK (EUCTR) | 04/11/2013 | 04/11/2013 | Treatment of Tenosynovitis among rheumatoid arthritis patients | Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTAN | MedDRA version: 16.0;Level: LLT;Classification code 10042869;Term: Synovitis and tenosynovitis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Diprofos Depot INN or Proposed INN: BETAMETHASONE ACIBUTATE Other descriptive name: Binyrebarkhormon Trade Name: Natriumklorid 9mg/ml INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE | Knowledge Centre for Rheumatology and Back Diseases | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 29 | NCT01393639 (ClinicalTrials.gov) | September 2011 | 13/6/2011 | Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis | A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug. | Rheumatoid Arthritis | Drug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 323 | Phase 2 | United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic |
| 30 | JPRN-UMIN000008164 | 2011/02/01 | 13/06/2012 | Restart for sustaining remission of rheumatoid arthritis in use of etanercept | Restart for sustaining remission of rheumatoid arthritis in use of etanercept - RESUME | Rheumatoid Arthritis | After the administration of etanercept (50mg/week), the dosage of etanercept will be discontinued when the low disease activity (DAS28-ESR<3.2) is achieved. If patients recur from low disease activity, same dose of etanercept will be administered again by the observation of every two months. This strategy will be maintained for two years. We must control the disease activity below the low disease activity using combined medicine except glucocorticoid if patients could not reach low disease activity after the administration of etanercept in three months. It will be considered to be a dropout if patients cannot reach low disease activity within six months. | Osaka City University Medical School | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Phase 4 | Japan |
| 31 | NCT01219933 (ClinicalTrials.gov) | January 2011 | 11/10/2010 | A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE) | An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE) | Rheumatoid Arthritis | Drug: methylprednisolone;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 68 | Phase 4 | Belgium |
| 32 | EUCTR2010-019694-15-BE (EUCTR) | 28/09/2010 | 28/07/2010 | Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone | Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone | Rheumatoid Arthritis in adult MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Medrol 4 mg tablets Other descriptive name: METHYLPREDNISOLONE Trade Name: Medrol A 16 mg tablets Other descriptive name: METHYLPREDNISOLONE | N.V. Roche S.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Belgium | |||
| 33 | EUCTR2009-017051-10-NL (EUCTR) | 13/07/2010 | 25/05/2010 | Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis | Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis | Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher.Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use. MedDRA version: 12.0;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up | Trade Name: Dexamethason Product Name: dexamethason | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 34 | EUCTR2008-005708-18-GB (EUCTR) | 04/06/2010 | 14/04/2010 | Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess | Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess | Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome | Trade Name: Glucophage (metformin) Product Name: Metformin | Queen Mary University of London | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 35 | NCT01287533 (ClinicalTrials.gov) | April 2010 | 30/1/2011 | Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids | Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids | Rheumatoid Arthritis;Osteoporosis;Osteopenia | Drug: Ibandronate;Drug: Placebo | Yeong-Wook Song | NULL | Completed | 18 Years | 75 Years | Female | 167 | Phase 4 | Korea, Republic of |
| 36 | EUCTR2007-000082-38-DK (EUCTR) | 24/05/2007 | 26/03/2007 | The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study | The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study | In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira (adalimumab) Product Name: Humira® (adalimumab) Product Code: 2593 INN or Proposed INN: Adalimumab | Aarhus University Hospital, Denmark | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Denmark | ||
| 37 | NCT00138983 (ClinicalTrials.gov) | May 2000 | 29/8/2005 | Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. | Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Completed | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |