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 | EUCTR2020-005773-27-FR (EUCTR) | 09/03/2021 | 19/01/2021 | BARIcitinib Cognitive Emotional and Neural signaTuREBARICENTRE | BARIcitinib Cognitive Emotional and Neural signaTuREBARICENTRE - BARICENTRE | Patients with rheumatoid arthritis and indication of baricitinib treatment according to a rheumatologist MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: OLUMIANT 4 mg Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: OLUMIANT 4mg Product Name: Baricitinib INN or Proposed INN: BARICITINIB | ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | France | ||
| 2 | ITMCTR1900002628 | 2020-04-01 | 2019-09-28 | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | Rheumatoid arthritis | the experimental group:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu and TCM were maintained;the control group 1:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu dosage reduction combined with traditional Chinese medicine was maintained;the control group 2:Subcutaneously injected 50mg per week for 24 weeks.From 24 weeks to 52 weeks, TCM maintenance treatment; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 65 | Both | the experimental group:40;the control group 1:30;the control group 2:30; | Phase 4 | China |
| 3 | ChiCTR1900026270 | 2020-04-01 | 2019-09-28 | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | Rheumatoid arthritis | the experimental group:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu and TCM were maintained;the control group 1:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu dosage reduction combined with traditional Chinese medicine was maintained;the control group 2:Subcutaneously injected 50mg per week for 24 weeks.From 24 weeks to 52 weeks, TCM maintenance treatment; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 65 | Both | the experimental group:40;the control group 1:30;the control group 2:30; | Phase 4 | China |
| 4 | JPRN-jRCTs071180018 | 13/04/2018 | 15/02/2019 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Kawakami Atsushi | NULL | Complete | >= 20age old | Not applicable | Both | 44 | Phase 4 | Japan |
| 5 | JPRN-UMIN000030575 | 2018/03/31 | 26/12/2017 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Daiichi Sankyo Company, Limited | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 44 | Not applicable | Japan |
| 6 | NCT03100253 (ClinicalTrials.gov) | March 1, 2018 | 17/3/2017 | Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation | Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol | Mario Negri Institute for Pharmacological Research | NULL | Terminated | 18 Years | N/A | All | 208 | Phase 4 | Italy |
| 7 | EUCTR2016-001987-12-IT (EUCTR) | 18/08/2017 | 05/01/2021 | Clinical study aimed to compare tocilizumab to anti-TNF treatment and to discover biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF | Open-label, randomized controlled trial comparing tocilizumab to anti-TNF treatment and discovery of biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF - RAFTING | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039014;Term: Rh arthritis;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO Product Name: Tocilizumab Product Code: [NA] INN or Proposed INN: Tocilizumab Other descriptive name: Tocilizumab Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: etanercept Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: Infliximab Product Code: [NA] INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI | SOCIETA' ITALIANA DI REUMATOLOGIA - SIR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 4 | Italy | ||
| 8 | EUCTR2015-000570-35-IT (EUCTR) | 10/02/2016 | 26/01/2021 | Prevention of re-onset of HBV infection in patients apparently cured affected by rheumatological diseases requiring finite duration treatments with drugs that impair the immune systems. | Prophylaxis of Hepatitis B reactivation in patients with HBV occult infection and rheumatological diseases candidates to immune suppressive treatments of finite duration. - Prophylaxis of OBI reactivation | Occult Hepatitis B virus Infection (OBI) in patients with rheumatologic diseases candidate to treatment a finite duration (less than 18 months) with potent immune suppressive drugs MedDRA version: 20.0;Level: HLT;Classification code 10037163;Term: Psoriatic arthropathies;System Organ Class: 100000004859 MedDRA version: 20.1;Classification code 10057212;Term: Hepatitis viral infections;System Organ Class: 100000004862 MedDRA version: 20.0;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Virus Diseases [C02] | Trade Name: VIREAD - 245 MG 30 COMPRESSE RIVESTITE CON FILM IN FLACONE USO ORALE Product Name: VIREAD 30 CPR 245 MG Product Code: 35565011 | DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | Italy | ||
| 9 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit | INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| 10 | NCT02764515 (ClinicalTrials.gov) | September 2015 | 26/3/2016 | Kunxian for the Treatment of Rheumatoid Arthritis | Comparison of the Efficacy and Safety of Kunxian Capsule and Methotrexate for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Kunxian Capsule;Drug: Methotrexate | Chinese SLE Treatment And Research Group | CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group;CHINESE RHEUMATISM DATA CENTER | Recruiting | 40 Years | 70 Years | All | 428 | Phase 4 | China |
| 11 | NCT02242474 (ClinicalTrials.gov) | July 2015 | 15/9/2014 | Anti-TNFa Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis | Prospective Randomized Multicentric Trial on Anti-TNFa Treatment and Infection Risk in the Perioperative Period During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Anti-TNF suspended perioperatively;Drug: Anti-TNFa continued perioperatively | CHU de Quebec-Universite Laval | NULL | Unknown status | 18 Years | N/A | All | 660 | Phase 4 | Canada |
| 12 | JPRN-UMIN000012364 | 2014/01/10 | 25/11/2013 | Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis. | Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis. - Research for an appropriate use of tramadol / acetaminophen combination tablets for patient with rheumatoid arthritis. | rheumatoid arthritis | Tramadol / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief. Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows; *Day1-Day7(1 tablet/day, after night meal) *Day8-Day14(1 tabletX2 times /day, after morning and night meal) *Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal *Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime) Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks. | Osaka City University Medical School, Department of Orthopedic Surgery | NULL | Complete: follow-up complete | 25years-old | 75years-old | Male and Female | 31 | Not applicable | Japan |
| 13 | NCT01661140 (ClinicalTrials.gov) | September 2012 | 7/8/2012 | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage | Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX | Rheumatoid Arthritis | Drug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose) | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 427 | Phase 4 | United Kingdom |
| 14 | EUCTR2011-005260-20-GB (EUCTR) | 28/06/2012 | 10/05/2012 | RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor. | Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER | Adult Rheumatoid Arthritis (RA) 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 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium | Roche Products Limited | NULL | Not Recruiting | Female: yes Male: yes | 618 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 15 | NCT01374971 (ClinicalTrials.gov) | September 2011 | 14/6/2011 | Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia) | Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression | Rheumatoid Arthritis | Drug: Certolizumab Pegol (CZP);Procedure: Arthroscopic synovial tissue biopsy | Nathan Wei, MD, FACP, FACR: | University of California, San Diego | Completed | 18 Years | N/A | All | 12 | Phase 3 | United States |
| 16 | EUCTR2010-020499-50-GB (EUCTR) | 07/02/2011 | 31/12/2010 | Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis. | Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis. | rheumatoid arthritis MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis | Trade Name: MabThera Product Name: rituximab | South Tees Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 4 | United Kingdom | ||
| 17 | JPRN-UMIN000008756 | 2010/11/01 | 30/08/2012 | Abatacept-based approach to cure of RA | Abatacept-based approach to cure of RA - ACURE study | Rheumatoid Arthritis | Abatacept treatmentat month 12 MTX treatment at month 12 | University of Occupational and Environmental Health, Japan | NULL | Recruiting | 15years-old | Not applicable | Female | 40 | Not selected | Japan |
| 18 | NCT01184001 (ClinicalTrials.gov) | September 2010 | 17/8/2010 | A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects | A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects | Rheumatoid Arthritis | Drug: Treatment A;Drug: Treatment B | Pfizer | NULL | Completed | 21 Years | 55 Years | Both | 16 | Phase 1 | Singapore |
| 19 | NCT01184092 (ClinicalTrials.gov) | August 2010 | 16/8/2010 | A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550) | Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions | Rheumatoid Arthritis | Drug: Treatment A;Drug: Treatment B;Drug: Treatment C | Pfizer | NULL | Completed | 21 Years | 55 Years | Both | 24 | Phase 1 | Singapore |
| 20 | EUCTR2007-006657-63-HU (EUCTR) | 26/03/2010 | 15/02/2010 | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA | Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel 25 mg powder and solvent for solution for injection Product Name: Enbrel Trade Name: Enbrel 50 mg powder and solvent for solution for injection Product Name: Enbrel | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 4 | Hungary;Finland;Denmark;Iceland;Sweden | ||
| 21 | EUCTR2007-006657-63-IS (EUCTR) | 10/03/2010 | 18/02/2010 | Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA) | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA | Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;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: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT | Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Finland;Iceland;Denmark;Norway;Sweden | |||
| 22 | EUCTR2007-006657-63-FI (EUCTR) | 08/05/2009 | 27/01/2009 | Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA) | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA | Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;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: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT | Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Finland;Iceland;Denmark;Norway;Sweden | |||
| 23 | EUCTR2007-006657-63-DK (EUCTR) | 16/04/2009 | 20/02/2009 | Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA) | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA | Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.1;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: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT | Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Finland;Denmark;Iceland;Norway;Sweden | |||
| 24 | EUCTR2007-006657-63-SE (EUCTR) | 25/03/2009 | 06/02/2009 | Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA) | Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA | Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;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: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT | Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Finland;Denmark;Norway;Iceland;Sweden | |||
| 25 | EUCTR2008-001847-20-IT (EUCTR) | 18/01/2009 | 18/12/2008 | Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND | Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND | Adult patients with active moderate to severe (DAS28 > 4.4) rheumatoid arthritis (RA) who have inadequately responded to prior conventional MTX treatment and have not been treated with any biologic agent before. MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid | Product Name: Tocilizumab Product Code: RO04877533 Trade Name: Methotrexate Lederle 2.5 mg Tablets INN or Proposed INN: Methotrexate Product Name: Tocilizumab Product Code: RO04877533 | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 470 | France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;United Kingdom;Italy;Sweden | |||
| 26 | ChiCTR-TCC-12002824 | 2008-07-10 | 2012-12-08 | Traditional Chinese and anti-rheumatic drugs for the treatment of rheumatoid arthritis | Integration of Traditional Chinese and Western Medicine treat rheumatoid witharthritis: A prospective, randomized, controlled trial | rheumatoid arthritis with peptic ulcer | Acupuncture treatment:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint. ;ARD treatment:esomeprazole magnesium enteric-coated tablets ,celecoxib capsules and methotrexate tablets ;Combined therapy:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint + oral Shanhuang Wuji decoction ; | Hospital of Chengdu Military Area Command PLA | NULL | Completed | 45 | 65 | Both | Acupuncture treatment:20;ARD treatment:20;Combined therapy:20; | China | |
| 27 | NCT00660647 (ClinicalTrials.gov) | September 2007 | 10/4/2008 | Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) | Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Adalimumab;Drug: Placebo | University of Aarhus | Abbott;Meda Pharmaceuticals;Aarhus University Hospital | Completed | 18 Years | N/A | Both | 180 | Phase 3 | Denmark |
| 28 | 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 | ||
| 29 | EUCTR2011-001626-15-ES (EUCTR) | 20/10/2011 | A study of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with rheumatoid arthritis with inadequate response to prior treatment with methotrexate and low disease activity with the combination de RoActemra/Actemra y methotrexate. | A multi-centre, randomized, double-blind study of the safety and efficacy of tocilizumab (TCZ) in combination with methotrexate (MTX), versus TCZ (placebo controlled) in patients with active rheumatoid arthritis (RA) with inadequate response to prior MTX treatment and low disease activity (DAS 28 ? 3.2) with the combination TCZ and MTX. | Rheumatoid arthritis MedDRA version: 14.0;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 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium | Roche Farma, S.A. | NULL | Not Recruiting | Female: yes Male: yes | Spain |