Golimumab ( DrugBank: Golimumab )
8 diseases
| 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 | 105 |
| 56 | ベーチェット病 | 1 |
| 84 | サルコイドーシス | 8 |
| 96 | クローン病 | 7 |
| 97 | 潰瘍性大腸炎 | 99 |
| 107 | 若年性特発性関節炎 | 9 |
| 270 | 慢性再発性多発性骨髄炎 | 1 |
| 271 | 強直性脊椎炎 | 18 |
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
| 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 | NCT04115423 (ClinicalTrials.gov) | April 1, 2020 | 2/10/2019 | A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab | A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database | Infection;Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab) | Sungkyunkwan University | Ministry of Food and Drug Safety, Korea | Active, not recruiting | 18 Years | N/A | All | 9508 | Korea, Republic of | |
| 2 | EUCTR2019-003700-12-FR (EUCTR) | 13/03/2020 | 04/06/2020 | Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients | Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug | rheumatoid arthritis MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Methotrexate Product Code: MTX Other descriptive name: METHOTREXATE DISODIUM Product Code: bDMARD INN or Proposed INN: INFLIXIMAB INN or Proposed INN: ETANERCEPT INN or Proposed INN: ADALIMUMAB INN or Proposed INN: CERTOLIZUMAB PEGOL INN or Proposed INN: GOLIMUMAB | CHU Saint-Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | France | ||
| 3 | EUCTR2019-004101-27-NL (EUCTR) | 15/01/2020 | 12/12/2019 | Research into injecting golimumab less frequently by using increased doses | INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’ - INDIGO | rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sint Maartenskliniek | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 4 | NCT04188249 (ClinicalTrials.gov) | July 1, 2019 | 27/6/2019 | Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis | A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Golimumab | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 200 | China | |
| 5 | NCT03729349 (ClinicalTrials.gov) | January 15, 2019 | 1/11/2018 | Golimumab for Adherence in Rheumatoid Arthritis | Golimumab for Adherence in Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Golimumab | Janssen Inc. | NULL | Active, not recruiting | 18 Years | 85 Years | All | 222 | Canada | |
| 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 | EUCTR2016-003129-40-IT (EUCTR) | 05/01/2017 | 10/09/2021 | Remission after suspension of TNF alpha therapies in RA | PHASE 4, MULTICENTER RANDOMISED STUDY, AIMED AT EVALUATING THE MAINTENANCE OF REMISSION AFTER 6, 12, 18 AND 24 MONTHS FROM SUSPENSION OF TNF-ALPHA THERAPIES (ADALIMUMAB, ETANERCEPT, INFLIXIMAB, CERTOLIZUMAB PEGOL, GOLIMUMAB) IN RHEUMATOID ARTHRITIS (RA) PATIENTS - NA | RHEUMATOID ARTHRITIS (RA) PATIENTS MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 2 SIRINGHE PRERIEMPITE 0.8 ML + 2 TAMPONI IMBEVUTI DI ALCOL IN 1 BLISTER Product Name: HUMIRA (ADALIMUMAB) 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 ALCOOL Product Name: CIMZIA (Certolizumab Pegol) Product Code: [NA] INN or Proposed INN: CERTOLIZUMAB PEGOL 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: ENBREL (Etanercept) Product Code: [-] 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: REMICADE (INFLIXIMAB) Product Code: [-] INN or Proposed INN: INFLIXIMAB Trade Name: SIMPONI - 50 MG-SOLUZIONE PER INIEZIONE IN PENNA PRERIEMPITA-USO SOTTOCUTANEO-PENNA PRERIEMPITA(VETRO) -0.5 ML 3 (3X1) PENNE PRERIEMPITE | AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Italy | ||
| 8 | NCT03016260 (ClinicalTrials.gov) | December 2016 | 4/1/2017 | RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis | Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination. | RheumatoId Arthritis | Biological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilar | TcLand Expression S.A. | European Commission | Terminated | 18 Years | N/A | All | 250 | Czechia;France;Israel;Netherlands;Turkey;Czech Republic | |
| 9 | EUCTR2015-004858-17-NL (EUCTR) | 05/10/2016 | 28/09/2016 | REMission INDuction in very early Rheumatoid Arthritis | REMission INDuction in very early Rheumatoid Arthritis - REMINDRA | Very early 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] - Musculoskeletal Diseases [C05] | Trade Name: Methotrexate Product Name: Methotrexate Product Code: MTX INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Golimumab Product Name: Golimumab Product Code: GOL INN or Proposed INN: GOLIMUMAB | University Medical Center Utrecht (UMCU) | NULL | Not Recruiting | Female: yes Male: yes | 267 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 10 | NCT02728934 (ClinicalTrials.gov) | February 25, 2016 | 31/3/2016 | Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis | Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar Infliximab | Janssen Scientific Affairs, LLC | NULL | Completed | 18 Years | N/A | All | 1279 | United States | |
| 11 | 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 | ||
| 12 | JPRN-UMIN000016950 | 2015/03/27 | 03/04/2015 | Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept | Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept - Clinical outcome in patients with RA switched to TNF blocker after tocilizumab or abatacept | rheumatoid arthritis | Infliximab or adalimumab or golimumab | Osaka Medical College | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 13 | NCT02414984 (ClinicalTrials.gov) | March 2015 | 8/4/2015 | Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab | Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia | Rheumatoid Arthritis | Biological: Golimumab | Janssen-Cilag, S.A. | NULL | Terminated | 18 Years | N/A | All | 37 | N/A | Colombia |
| 14 | NCT02390700 (ClinicalTrials.gov) | February 2015 | 11/3/2015 | Observational Study of Golimumab Intravenous Infusion | Golimumab Intravenous Infusion Registry (GO-IV) | Rheumatoid Arthritis | Biological: Golimumab Intravenous | Janssen Inc. | NULL | Terminated | 18 Years | N/A | Both | 78 | Canada | |
| 15 | JPRN-UMIN000016844 | 2014/02/07 | 20/03/2015 | The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors | The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors - The aggressive clinical tight control study(TACTICS trial) | Rheumatoid arthritis | infliximab: standard strategy infliximab: aggressive strategy golimumab: standard strategy golimumab: aggressive strategy | Takarazuka city hospital | NULL | Recruiting | 20years-old | 90years-old | Male and Female | 80 | Not applicable | Japan |
| 16 | JPRN-UMIN000011891 | 2013/10/01 | 01/10/2013 | Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. | Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. - GLORIA study | Rheumatoid Arthritis | Golimumab | St.Marianna University School of Medicine | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 50 | Not selected | Japan |
| 17 | NCT01962974 (ClinicalTrials.gov) | October 2013 | 11/10/2013 | A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) | A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) | Arthritis, Rheumatoid | Biological: Golimumab 2 mg/kg IV | Janssen Biotech, Inc. | NULL | Terminated | 18 Years | 76 Years | All | 7 | Phase 3 | United States;Canada;Argentina;Brazil;Colombia;Mexico |
| 18 | EUCTR2011-005649-10-DE (EUCTR) | 19/08/2013 | 18/07/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 16.0;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: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 19 | EUCTR2011-005649-10-GB (EUCTR) | 05/07/2013 | 11/03/2013 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Protocol:CD-IA-CAM-3001-1107 - Mavrilimumab versus Anti tumor Necrosis Factor in Rheumatoid Arthritis | Rheumatoid arthritis 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] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 20 | EUCTR2012-004482-40-ES (EUCTR) | 18/06/2013 | 16/05/2013 | Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies | Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized. | Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: ENBREL Product Name: Etanercept INN or Proposed INN: ETANERCEPT Trade Name: CIMZIA Product Name: Certolizumab Pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: SIMPONI Product Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: TOCILIZUMAB Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | FRANCISCO J. BLANCO GARCÍA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 21 | JPRN-UMIN000014485 | 2013/05/24 | 01/12/2014 | Golimumab study for development of tight control and biologics-free condition. | Golimumab study for development of tight control and biologics-free condition. - Go-sunrising study | rheumatoid arthritis | Treatment with Golimumab for patients with rheumatoid arthritis | Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 22 | EUCTR2011-005649-10-SK (EUCTR) | 11/03/2013 | 06/02/2013 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis 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] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 23 | NCT01715896 (ClinicalTrials.gov) | March 2013 | 16/10/2012 | A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Golimumab 50 mg;Biological: Mavrilimumab 100 mg | MedImmune LLC | NULL | Completed | 18 Years | 80 Years | All | 215 | Phase 2 | Argentina;Colombia;Czech Republic;France;Greece;Hungary;Israel;Mexico;Portugal;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Turkey |
| 24 | EUCTR2011-005649-10-CZ (EUCTR) | 18/02/2013 | 11/12/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis 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] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Brazil;Germany | ||
| 25 | EUCTR2011-005649-10-HU (EUCTR) | 05/02/2013 | 27/11/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis 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] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 26 | EUCTR2011-005649-10-PT (EUCTR) | 04/01/2013 | 10/09/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 27 | JPRN-UMIN000009425 | 2012/12/06 | 01/12/2012 | A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient | A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient - Go-Go trial | Rheumatoid Arthritis | The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity. Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year. Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year. | Osaka City University Medical School | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Phase 4 | Japan |
| 28 | EUCTR2011-005649-10-ES (EUCTR) | 22/10/2012 | 19/07/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 15.0;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: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 29 | EUCTR2011-005649-10-GR (EUCTR) | 03/10/2012 | 05/10/2012 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 15.0;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: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Czech Republic;Mexico;Argentina;Brazil;Germany;Hungary;Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France | ||
| 30 | EUCTR2011-005204-15-AT (EUCTR) | 20/06/2012 | 15/05/2012 | Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped? | Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop | biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Simponi INN or Proposed INN: GOLIMUMAB Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT | Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 4 | Austria | ||
| 31 | NCT01602302 (ClinicalTrials.gov) | June 2012 | 16/5/2012 | Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis | Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept) | Medical University of Graz | NULL | Terminated | 18 Years | 90 Years | All | 40 | Phase 4 | Austria |
| 32 | EUCTR2011-000311-34-IT (EUCTR) | 03/02/2012 | 06/12/2011 | GO-AHEAD | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also known as MK-8259-006-00). - GO-AHEAD | Active Axial Spondyloarthritis (SpA) MedDRA version: 14.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | SCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Canada;Finland;Spain;Turkey;Russian Federation;Germany;United Kingdom;Italy | ||
| 33 | NCT01295151 (ClinicalTrials.gov) | August 2011 | 11/2/2011 | SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug. | Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug | Rheumatoid Arthritis | Drug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: Golimumab | Julia Brown | NULL | Completed | 18 Years | N/A | Both | 122 | Phase 4 | United Kingdom |
| 34 | EUCTR2009-015019-42-DE (EUCTR) | 10/05/2011 | 20/08/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands | |||
| 35 | EUCTR2010-021020-94-HU (EUCTR) | 08/04/2011 | 05/10/2010 | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | active rheumatoid arthritis MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SAR153191 Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Czech Republic;Germany;Spain;Italy | |||
| 36 | EUCTR2009-015019-42-BE (EUCTR) | 04/04/2011 | 06/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany | ||
| 37 | EUCTR2010-021020-94-DE (EUCTR) | 10/03/2011 | 15/09/2010 | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | active rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Czech Republic;Germany;Spain;Italy | |||
| 38 | EUCTR2010-021020-94-ES (EUCTR) | 21/12/2010 | 21/10/2010 | Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-? | Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-? | artritis reumatoide activa MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: SAR153191 Trade Name: SIMPONI 50 mg solución inyectable en pluma precargada INN or Proposed INN: GOLIMUMAB Other descriptive name: GOLIMUMAB | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Czech Republic;Germany;Spain;Italy | |||
| 39 | EUCTR2010-021020-94-CZ (EUCTR) | 17/12/2010 | 05/10/2010 | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a | active rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Germany;Czech Republic;Spain;Italy | |||
| 40 | EUCTR2009-015019-42-FI (EUCTR) | 17/11/2010 | 27/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands | |||
| 41 | EUCTR2009-015019-42-LT (EUCTR) | 02/11/2010 | 17/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 42 | NCT01217814 (ClinicalTrials.gov) | November 2010 | 7/10/2010 | Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-a Blockers | A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-a Antagonists | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Placebo;Drug: Golimumab;Drug: methotrexate (MTX);Drug: Folic/folinic acid | Sanofi | Regeneron Pharmaceuticals | Terminated | 18 Years | 75 Years | All | 16 | Phase 2 | United States;Colombia;Czechia;Italy;Mexico;Spain;Brazil;Canada;Czech Republic;Germany;Hungary;Norway |
| 43 | EUCTR2010-021020-94-IT (EUCTR) | 15/10/2010 | 28/09/2010 | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-alpha) antagonists. - ND | A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-alpha) antagonists. - ND | active rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073 | Product Code: SAR153191 Trade Name: SIMPONI INN or Proposed INN: GOLIMUMAB | Sanofi-aventis Recherche & D?veloppement | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Czech Republic;Germany;Spain;Italy | |||
| 44 | EUCTR2009-015019-42-AT (EUCTR) | 05/10/2010 | 01/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 45 | NCT01248780 (ClinicalTrials.gov) | September 2010 | 24/11/2010 | Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Golimumab;Drug: Placebo;Drug: Methotrexate (MTX) | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 264 | Phase 3 | China |
| 46 | EUCTR2009-010582-23-GR (EUCTR) | 15/06/2010 | 30/12/2009 | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?) | Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal Product Name: Golimumab prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 47 | EUCTR2009-015740-42-DE (EUCTR) | 12/05/2010 | 12/01/2010 | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: A | Universitätsklinkum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 3 | Germany | ||
| 48 | EUCTR2009-011137-26-PL (EUCTR) | 01/04/2010 | 25/01/2010 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland | ||||
| 49 | NCT01313858 (ClinicalTrials.gov) | April 2010 | 10/3/2011 | A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) | Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis | Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing | Drug: Simponi®;Drug: Methotrexate | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 1613 | N/A | Germany |
| 50 | EUCTR2009-011137-26-GR (EUCTR) | 22/03/2010 | 20/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 51 | EUCTR2009-010582-23-IT (EUCTR) | 10/03/2010 | 08/01/2010 | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - ND | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - ND | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: golimumab Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: golimumab | CENTOCOR | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 52 | EUCTR2009-011137-26-PT (EUCTR) | 01/03/2010 | 09/12/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | |||
| 53 | EUCTR2009-011137-26-CZ (EUCTR) | 26/02/2010 | 13/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 54 | EUCTR2009-011137-26-AT (EUCTR) | 25/02/2010 | 04/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 55 | EUCTR2009-011137-26-IT (EUCTR) | 15/02/2010 | 02/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-na?ve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO -MORE | Active Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073 | Product Name: Golimumab Product Code: SCH900259 Product Name: Golimumab Product Code: SCH 900259 | Shering Plough Research Institute, A division of Schering Plough Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 56 | EUCTR2009-010582-23-BE (EUCTR) | 10/02/2010 | 23/09/2009 | Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 57 | EUCTR2008-006064-11-HU (EUCTR) | 20/01/2010 | 27/10/2009 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 564 | Hungary;Lithuania | |||
| 58 | EUCTR2009-011137-26-BE (EUCTR) | 18/01/2010 | 19/10/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 59 | EUCTR2009-010582-23-DE (EUCTR) | 04/01/2010 | 22/09/2009 | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 60 | EUCTR2009-010582-23-GB (EUCTR) | 31/12/2009 | 28/06/2010 | Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Greece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 61 | EUCTR2008-006064-11-LT (EUCTR) | 30/12/2009 | 19/10/2009 | An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroids | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid arthritis (RA) 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 564 | United States;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;Australia;New Zealand;Korea, Republic of | |||
| 62 | EUCTR2009-011137-26-IE (EUCTR) | 21/12/2009 | 15/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | |||
| 63 | EUCTR2009-010582-23-SE (EUCTR) | 16/12/2009 | 23/10/2009 | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 64 | EUCTR2009-011137-26-FR (EUCTR) | 15/12/2009 | 10/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 65 | EUCTR2009-011137-26-DK (EUCTR) | 07/12/2009 | 02/11/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland | ||||
| 66 | EUCTR2009-011137-26-NL (EUCTR) | 02/12/2009 | 31/08/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 67 | NCT01004432 (ClinicalTrials.gov) | December 2009 | 29/10/2009 | Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA) | Arthritis;Arthritis, Rheumatoid;Autoimmune Diseases | Drug: Golimumab 50 mg SC;Drug: Golimumab 2 mg/kg IV;Drug: Methotrexate (MTX);Drug: Placebo SC;Drug: Placebo IV | Janssen Biotech, Inc. | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 433 | Phase 3 | United States;Austria;Belgium;Canada;Germany;Greece;Sweden;United Kingdom;France;Spain |
| 68 | EUCTR2009-010582-23-AT (EUCTR) | 26/11/2009 | 12/10/2009 | Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | Rheumatoid arthritis 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 69 | EUCTR2009-011137-26-SK (EUCTR) | 11/11/2009 | 19/11/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 70 | EUCTR2009-011137-26-ES (EUCTR) | 23/10/2009 | 06/08/2009 | Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE | Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE | Artritis reumatoide MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 71 | EUCTR2009-011137-26-FI (EUCTR) | 22/10/2009 | 25/08/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 72 | EUCTR2009-011137-26-GB (EUCTR) | 19/10/2009 | 18/10/2010 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 73 | EUCTR2009-011137-26-HU (EUCTR) | 19/10/2009 | 02/09/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland | ||||
| 74 | EUCTR2009-011137-26-DE (EUCTR) | 05/10/2009 | 03/08/2009 | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE | Active Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab | Schering-Plough Research Institute, A Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 3150 | Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands | |||
| 75 | NCT00975130 (ClinicalTrials.gov) | September 2009 | 20/8/2009 | Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) | An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2) | Arthritis, Rheumatoid | Biological: SC golimumab;Biological: IV golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 3366 | Phase 3 | Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom |
| 76 | NCT00973479 (ClinicalTrials.gov) | September 2009 | 4/9/2009 | An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFalpha Monoclonal Antibody, Administered Intravenously, in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Arthritis, Rheumatoid | Drug: Golimumab;Other: Placebo;Drug: methotrexate (MTX) | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 592 | Phase 3 | United States;Argentina;Australia;Colombia;Hungary;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Russian Federation;Ukraine |
| 77 | NCT01081717 (ClinicalTrials.gov) | April 14, 2009 | 4/3/2010 | Golimumab Safety and Surveillance Program Using the Ingenix NHI Database | A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments | Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis | Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population | Janssen Biotech, Inc. | NULL | Completed | N/A | 99 Years | All | 1064 | United States | |
| 78 | NCT00727987 (ClinicalTrials.gov) | May 2008 | 31/7/2008 | A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CNTO 148;Drug: Placebo;Drug: Methotrexate (MTX) | Janssen Pharmaceutical K.K. | Mitsubishi Tanabe Pharma Corporation | Completed | 20 Years | 74 Years | Both | 269 | Phase 3 | Japan |
| 79 | NCT00771251 (ClinicalTrials.gov) | May 2008 | 10/10/2008 | A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA) | A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CNTO 148;Drug: Placebo | Janssen Pharmaceutical K.K. | Mitsubishi Tanabe Pharma Corporation;Mitsubishi Tanabe Pharma Corporation | Completed | 20 Years | 74 Years | Both | 311 | Phase 3 | Japan |
| 80 | NCT01362153 (ClinicalTrials.gov) | December 26, 2007 | 10/3/2011 | A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA) | An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Golimumab | Centocor, Inc. | NULL | Completed | 18 Years | 99 Years | All | 49 | Phase 1 | United States |
| 81 | NCT03414502 (ClinicalTrials.gov) | August 2007 | 2/1/2014 | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Abatacept;Drug: Adalimumab;Drug: Azathioprine;Drug: Baricitinib;Drug: Certolizumab;Drug: Etanercept;Drug: Golimumab;Drug: Hydroxychloroquine;Drug: Infliximab;Drug: Leflunomide;Drug: Minocycline;Drug: Rituximab;Drug: Sarilumab;Drug: Sulfasalazine;Drug: Tofacitinib | University of Nebraska | NULL | Recruiting | 19 Years | N/A | All | 400 | Phase 3 | United States |
| 82 | EUCTR2005-003232-21-DE (EUCTR) | 11/12/2006 | 04/09/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary;Germany;Malta;Latvia;Lithuania | |||
| 83 | EUCTR2005-003232-21-MT (EUCTR) | 07/12/2006 | 18/01/2007 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary;Germany;Malta;Latvia;Lithuania | |||
| 84 | EUCTR2005-003232-21-LT (EUCTR) | 30/11/2006 | 10/10/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab pre-filled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary;Germany;Malta;Latvia;Lithuania | |||
| 85 | EUCTR2005-003232-21-HU (EUCTR) | 22/11/2006 | 06/09/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary;Germany;Malta;Latvia;Lithuania | |||
| 86 | EUCTR2005-003232-21-LV (EUCTR) | 02/10/2006 | 29/09/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis (RA) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary;Germany;Malta;Latvia;Lithuania | |||
| 87 | EUCTR2005-001742-16-NL (EUCTR) | 06/09/2006 | 22/03/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NA | Active rheumatoid arthritis (RA) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Germany;United Kingdom;Netherlands;Spain;Austria | |||
| 88 | NCT00361335 (ClinicalTrials.gov) | September 2006 | 4/8/2006 | A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Golimumab;Drug: Methotrexate;Drug: Placebo | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 643 | Phase 3 | United States;Argentina;Australia;Colombia;Germany;Hungary;Latvia;Lithuania;Malaysia;Malta;Mexico;New Zealand;Peru;Poland;Ukraine;Belgium;Russian Federation |
| 89 | EUCTR2004-003296-36-HU (EUCTR) | 10/07/2006 | 14/06/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA | Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Germany | |||
| 90 | EUCTR2004-003295-10-HU (EUCTR) | 04/07/2006 | 30/12/2005 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | Active Rheumatoid Arthritis (methotrexate [MTX]-naïve) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;United Kingdom;Spain;Italy | |||
| 91 | EUCTR2005-001742-16-DE (EUCTR) | 07/06/2006 | 23/03/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | United Kingdom;Germany;Netherlands;Spain;Austria | |||
| 92 | EUCTR2005-001742-16-ES (EUCTR) | 02/06/2006 | 19/04/2006 | Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa. | Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa. | Active rheumatoid arthritis (RA)Artritis Reumatoide activa | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Germany;United Kingdom;Netherlands;Spain;Austria | |||
| 93 | EUCTR2005-001742-16-GB (EUCTR) | 26/05/2006 | 03/03/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Finland;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 94 | EUCTR2005-001742-16-FI (EUCTR) | 17/05/2006 | 04/04/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Finland;Spain;Austria;Germany;Netherlands;United Kingdom | |||
| 95 | EUCTR2004-003295-10-GB (EUCTR) | 17/05/2006 | 08/12/2005 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | Active Rheumatoid Arthritis (methotrexate [MTX]-naïve) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Hungary;Spain;Austria;Italy;United Kingdom | ||
| 96 | EUCTR2005-001742-16-AT (EUCTR) | 01/05/2006 | 30/03/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Germany;United Kingdom;Netherlands;Spain;Austria | |||
| 97 | EUCTR2004-003295-10-ES (EUCTR) | 25/04/2006 | 17/02/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid ArthritisEnsayo múlticéntrico, aleatorizado, en doble ciego y controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa no tratados previamente con metotrexato | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid ArthritisEnsayo múlticéntrico, aleatorizado, en doble ciego y controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa no tratados previamente con metotrexato | Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)Artritis Reumatoide activa (no tratada previamente con metotrexato) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;United Kingdom;Spain;Italy | |||
| 98 | EUCTR2004-003296-36-DE (EUCTR) | 29/03/2006 | 24/11/2005 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA | Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Germany | |||
| 99 | EUCTR2004-003295-10-IT (EUCTR) | 20/02/2006 | 29/11/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05 | RA in subjects who are naive to metotrexate MedDRA version: 8.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders | Product Name: golimumab Product Code: CNTO148 INN or Proposed INN: Methotrexate Product Name: golimumab Product Code: CNTO148 | CENTOCOR | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Hungary;Spain;Austria;United Kingdom;Italy | ||
| 100 | NCT00299546 (ClinicalTrials.gov) | February 2006 | 3/3/2006 | A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s) | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s) | Arthritis, Rheumatoid | Drug: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 461 | Phase 3 | United States;Australia;Austria;Canada;Finland;Germany;Netherlands;New Zealand;Spain;United Kingdom;France;Switzerland |
| 101 | EUCTR2004-003295-10-AT (EUCTR) | 20/01/2006 | 16/12/2005 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA | Active Rheumatoid Arthritis (methotrexate [MTX]-naïve) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Spain;Austria;Italy;United Kingdom | |||
| 102 | NCT00264550 (ClinicalTrials.gov) | December 2005 | 11/12/2005 | An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Golimumab 100 mg;Drug: Golimumab 50 mg;Drug: Methotrexate;Drug: Placebo injection;Drug: Placebo capsules | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 444 | Phase 3 | United States;Argentina;Australia;Canada;Chile;Germany;Hungary;Korea, Republic of;Mexico;New Zealand;Poland;Taiwan;Brazil;India;Turkey |
| 103 | NCT00264537 (ClinicalTrials.gov) | December 2005 | 11/12/2005 | A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive | A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo injections;Drug: Placebo capsules;Drug: Methotrexate capsules;Biological: Golimumab 50 mg injections;Biological: Golimumab 100 mg injections | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 637 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Chile;Hungary;India;Korea, Republic of;Malaysia;New Zealand;Philippines;Poland;Russian Federation;Singapore;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Mexico;Turkey |
| 104 | NCT00207714 (ClinicalTrials.gov) | November 2003 | 13/9/2005 | An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis | A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate | Rheumatoid Arthritis | Drug: Golimumab;Drug: MTX;Drug: Placebo;Drug: Infliximab | Centocor, Inc. | Centocor BV | Completed | 18 Years | N/A | All | 172 | Phase 2 | NULL |
| 105 | EUCTR2009-015019-42-Outside-EU/EEA (EUCTR) | 08/03/2012 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 170 | Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico |
56. ベーチェット病
臨床試験数 : 81 / 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
| 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 | NCT04218565 (ClinicalTrials.gov) | February 15, 2020 | 8/12/2019 | Golimumab for the Treatment of Refractory Behcet's Uveitis | Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease | Behcet Syndrome;Uveitis | Biological: Golimumab (GOL) | Wenjie Zheng | NULL | Recruiting | 18 Years | 65 Years | All | 9 | Phase 2 | China |
84. サルコイドーシス
臨床試験数 : 149 / 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
| 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 | EUCTR2009-010714-30-IT (EUCTR) | 18/01/2010 | 11/12/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis - ND | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486 | Product Name: Ustekinumab Product Code: CNTO1275 Product Name: Golimumab Product Code: CNTO148 | CENTOCOR | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Italy | |||
| 2 | EUCTR2009-010714-30-NL (EUCTR) | 22/12/2009 | 03/02/2011 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis - | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Italy | |||
| 3 | EUCTR2009-010714-30-FR (EUCTR) | 10/11/2009 | 15/10/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | NCT00955279 (ClinicalTrials.gov) | November 2009 | 6/8/2009 | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis | Sarcoidosis | Drug: Placebo;Drug: Golimumab;Drug: Ustekinumab | Centocor, Inc. | NULL | Completed | 18 Years | 85 Years | All | 173 | Phase 2 | United States;Belgium;Denmark;France;Germany;Netherlands;Norway;Romania;United Kingdom;Sweden |
| 5 | EUCTR2009-010714-30-DE (EUCTR) | 23/10/2009 | 08/07/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2009-010714-30-DK (EUCTR) | 12/10/2009 | 17/08/2009 | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 14.0;Level: PT;Classification code 10039486;Term: Sarcoidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Belgium;Romania;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2009-010714-30-BE (EUCTR) | 28/09/2009 | 08/07/2009 | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 13.1;Level: PT;Classification code 10039486;Term: Sarcoidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: Human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Belgium;Denmark;Germany;Norway;Netherlands;Italy;United Kingdom | ||
| 8 | EUCTR2009-010714-30-GB (EUCTR) | 14/09/2009 | 20/07/2009 | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis | Chronic sarcoidosis MedDRA version: 9.1;Level: LLT;Classification code 10039486;Term: Sarcoidosis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: human anti TNF-alpha monoclonal antibody Product Name: ustekinumab liquid in prefilled syringe Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: human anti-IL 12/23 monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | EUCTR2021-003314-39-SI (EUCTR) | 22/12/2022 | 24/11/2022 | Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease - DUET-CD | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Proposed INN: Golimumab Other descriptive name: Golimumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Golimumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 715 | Phase 2 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Georgia;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden | ||
| 2 | EUCTR2021-003314-39-NL (EUCTR) | 14/12/2022 | 07/09/2022 | Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease - DUET-CD | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Proposed INN: Golimumab Other descriptive name: Golimumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Golimumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 715 | Phase 2 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Georgia;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden | ||
| 3 | JPRN-jRCT2031220309 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease - DUET-CD | Crohn's Disease | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 715 | Phase 2 | Argentina;Australia;Austria;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;China;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;Poland;Portugal;Serbia;Japan |
| 4 | NCT05242471 (ClinicalTrials.gov) | July 22, 2022 | 15/2/2022 | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 715 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Finland;Lithuania;Slovakia |
| 5 | NCT03885713 (ClinicalTrials.gov) | September 10, 2019 | 4/3/2019 | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 4 | Spain |
| 6 | EUCTR2018-002925-47-ES (EUCTR) | 28/12/2018 | 16/11/2018 | prediction of response to therapy in inflammatory bowel disease | Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches | Inflammatory bowel disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Vedolizumab INN or Proposed INN: VEDOLIZUMAB Other descriptive name: VEDOLIZUMAB | Fundación de Investigación Biomédica del Hospital Universitario de La Princesa | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 7 | NCT01804166 (ClinicalTrials.gov) | March 21, 2013 | 1/2/2013 | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | Hepatosplenic T-Cell Lymphoma | Drug: Infliximab;Drug: Golimumab | Janssen Scientific Affairs, LLC | NULL | Completed | N/A | N/A | All | 1 | Phase 4 | United States |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2021-005528-39-NL (EUCTR) | 14/12/2022 | 12/09/2022 | Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Proposed INN: Golimumab Other descriptive name: Golimumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Golimumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 2 | Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;India;France;Jordan;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Switzerland;Malaysia;Australia;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Bulgaria;Georgia;Germany;Norway;New Zealand;Japan | ||
| 2 | JPRN-jRCT2031220308 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC | Colitis, Ulcerative | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 550 | Phase 2 | Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;NewZealand;Poland;Portugal;Serbia;Japan |
| 3 | NCT05242484 (ClinicalTrials.gov) | September 19, 2022 | 15/2/2022 | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 550 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Jordan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Lithuania |
| 4 | EUCTR2021-002211-65-ES (EUCTR) | 13/08/2021 | 11/06/2021 | EFFECT OF TOFACITINIB ON COAGULATION | EFFECT OF TOFACITINIB ON COAGULATION AND PLATELET FUNCTION, AND ITS ROLE IN THROMBOEMBOLIC EVENTS | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Level: PT;Classification code 10009790;Term: Coagulation time;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10061684;Term: Platelet function test;System Organ Class: 10022891 - Investigations;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Tofacitinib INN or Proposed INN: TOFACITINIB | Fundación Española de Gastroenterología | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Spain | ||
| 5 | NCT04156984 (ClinicalTrials.gov) | May 2020 | 24/10/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens | Ulcerative Colitis | Drug: Golimumab Prefilled Syringe | David Drobne | NULL | Not yet recruiting | 18 Years | 65 Years | All | 30 | Phase 4 | Slovenia |
| 6 | EUCTR2019-003987-37-SI (EUCTR) | 26/02/2020 | 27/11/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi Product Code: CNTO-148 | University Medical Centre Ljubljana, Department of gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Slovenia | ||
| 7 | EUCTR2017-004496-31-NL (EUCTR) | 20/09/2019 | 27/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 8 | NCT03885713 (ClinicalTrials.gov) | September 10, 2019 | 4/3/2019 | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 4 | Spain |
| 9 | EUCTR2018-001510-15-DE (EUCTR) | 02/05/2019 | 19/11/2018 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany | ||
| 10 | EUCTR2018-001510-15-PL (EUCTR) | 01/03/2019 | 04/02/2019 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany | ||
| 11 | EUCTR2017-004496-31-IT (EUCTR) | 18/02/2019 | 17/06/2021 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: SIMPONI Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Other descriptive name: D.3.6.2.1 - valore: 45 / 0.45 mg/ml Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: [CNTO312] INN or Proposed INN: INFLIXIMAB Other descriptive name: D.3.6.2.1 - valore: 5 o 10 mg/kg | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 12 | EUCTR2017-004496-31-PL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Belgium;Brazil;Poland;Israel;Netherlands;Italy;Korea, Republic of | ||
| 13 | EUCTR2018-002925-47-ES (EUCTR) | 28/12/2018 | 16/11/2018 | prediction of response to therapy in inflammatory bowel disease | Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches | Inflammatory bowel disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Vedolizumab INN or Proposed INN: VEDOLIZUMAB Other descriptive name: VEDOLIZUMAB | Fundación de Investigación Biomédica del Hospital Universitario de La Princesa | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 14 | EUCTR2017-004496-31-FR (EUCTR) | 17/12/2018 | 14/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 15 | NCT03662542 (ClinicalTrials.gov) | November 20, 2018 | 6/9/2018 | A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 65 Years | All | 214 | Phase 2 | United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine |
| 16 | EUCTR2017-004496-31-BE (EUCTR) | 07/11/2018 | 25/07/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Brazil;Belgium;Israel;Netherlands;Italy;Korea, Republic of | ||
| 17 | NCT03596645 (ClinicalTrials.gov) | October 29, 2018 | 13/7/2018 | A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Drug: Infliximab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 2 Years | 17 Years | All | 84 | Phase 3 | United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan |
| 18 | EUCTR2017-004496-31-ES (EUCTR) | 15/10/2018 | 28/08/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 19 | NCT03669029 (ClinicalTrials.gov) | October 1, 2018 | 4/7/2018 | Optimization of Golimumab Treatment in Ulcerative Colitis | Optimization of Golimumab Treatment in Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization. | Hospital de Manises | Valencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunto;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp. | Unknown status | 18 Years | 80 Years | All | 50 | Phase 4 | Spain |
| 20 | NCT03394586 (ClinicalTrials.gov) | January 1, 2018 | 28/12/2017 | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Ulcerative Colitis;Flare Up, Symptom | Drug: Exposure to golimumab | University of Zurich | NULL | Unknown status | N/A | N/A | All | 100 | Switzerland | |
| 21 | NCT05405465 (ClinicalTrials.gov) | January 1, 2018 | 31/5/2022 | Effectiveness of Golimumab in Patients With Ulcerative Colitis: Results of a Real-life Study in Switzerland | Effectiveness of Golimumab in Patients With Ulcerative Colitis: Results of a Real-life Study in Switzerland | Ulcerative Colitis;Flare Up, Symptom | Drug: Exposure to golimumab | University of Zurich | Merck Sharp & Dohme LLC | Completed | N/A | N/A | All | 103 | Switzerland | |
| 22 | NCT03182166 (ClinicalTrials.gov) | November 21, 2017 | 29/5/2017 | Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization | Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization | Ulcerative Colitis | Drug: Golimumab (Optimization);Diagnostic Test: Rectosigmoidoscopy;Biological: Blood samples | Centre Hospitalier Universitaire de Saint Etienne | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 51 | Phase 2 | France |
| 23 | NCT03124121 (ClinicalTrials.gov) | September 5, 2017 | 4/4/2017 | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels | Ulcerative Colitis | Drug: Golimumab | Guy's and St Thomas' NHS Foundation Trust | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 112 | Phase 4 | United Kingdom |
| 24 | EUCTR2017-001374-42-GB (EUCTR) | 21/07/2017 | 19/07/2017 | Measuring levels of golimumab to improve the understanding of differences in its effectiveness amongst patients with ulcerative colitis | Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels - GO-LEVEL | Ulcerative Colitis (UC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab | Guy's and St Thomas' NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 25 | EUCTR2016-001409-18-NO (EUCTR) | 06/12/2016 | 09/05/2016 | A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence | A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Helse More og Romsdal Hospital Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Norway | |||
| 26 | NCT02425865 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET | ULCERATIVE COLITIS | Drug: GOLIMUMAB | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Active, not recruiting | 18 Years | 75 Years | All | 202 | Phase 4 | Belgium;France |
| 27 | NCT03018925 (ClinicalTrials.gov) | October 2016 | 13/12/2016 | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study | Ulcerative Colitis | Drug: Golimumab | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | NULL | Recruiting | 18 Years | N/A | All | 15 | N/A | Spain |
| 28 | NCT02687724 (ClinicalTrials.gov) | June 2016 | 16/2/2016 | Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis | GLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC). | Colitis | Drug: Golimumab (GLM) | University College Dublin | NULL | Unknown status | 18 Years | N/A | All | 136 | Phase 4 | Ireland |
| 29 | EUCTR2015-004724-62-IE (EUCTR) | 22/12/2015 | 05/11/2015 | Golimumab dose variation to achieve response in Colitis | Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi INN or Proposed INN: GOLIMUMAB INN or Proposed INN: GOLIMUMAB | UCD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 4 | Ireland | ||
| 30 | EUCTR2014-002579-27-IT (EUCTR) | 03/03/2015 | 19/01/2015 | Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone | Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL | active steroid-dependent ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: SIMPONI Product Name: SIMPONI Product Code: NA INN or Proposed INN: GOLIMUMAB | Istituto Clinico Humanitas | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Italy | ||
| 31 | NCT02412085 (ClinicalTrials.gov) | March 2015 | 26/3/2015 | Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission | Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Istituto Clinico Humanitas | NULL | Recruiting | 18 Years | 65 Years | Both | 100 | Phase 4 | Italy |
| 32 | NCT02318667 (ClinicalTrials.gov) | February 27, 2015 | 12/12/2014 | Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). | An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab. | Colitis, Ulcerative | Biological: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 65 Years | All | 38 | Phase 4 | Portugal |
| 33 | EUCTR2013-002042-36-FR (EUCTR) | 04/02/2015 | 22/06/2015 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;United States | ||
| 34 | EUCTR2014-003262-25-PT (EUCTR) | 12/12/2014 | 20/11/2014 | Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab | An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 37 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal | ||
| 35 | EUCTR2013-002042-36-NL (EUCTR) | 24/09/2014 | 13/06/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany | ||
| 36 | EUCTR2013-002042-36-BG (EUCTR) | 11/09/2014 | 30/04/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 37 | EUCTR2013-002042-36-DE (EUCTR) | 31/07/2014 | 27/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 38 | EUCTR2013-002042-36-BE (EUCTR) | 10/07/2014 | 20/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 39 | NCT02155335 (ClinicalTrials.gov) | July 1, 2014 | 2/6/2014 | Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027) | Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Prefilled Syringe delivery of Golimumab;Drug: Smartject Device delivery of Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 100 | Phase 4 | Belgium |
| 40 | EUCTR2014-000656-29-BE (EUCTR) | 13/06/2014 | 05/03/2014 | Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device | Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi | MSD Belgium BVBA/SPRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 4 | Belgium | ||
| 41 | EUCTR2013-002042-36-PL (EUCTR) | 09/06/2014 | 06/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands | ||
| 42 | EUCTR2013-002042-36-CZ (EUCTR) | 04/06/2014 | 21/03/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 43 | NCT02186886 (ClinicalTrials.gov) | June 2014 | 1/7/2014 | Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab | Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi) | Ulcerative Colitis | Drug: Golimumab | Kliniken im Naturpark Altmuehltal | NULL | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | Germany |
| 44 | EUCTR2013-002042-36-HU (EUCTR) | 12/05/2014 | 21/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany | ||
| 45 | NCT02092285 (ClinicalTrials.gov) | May 9, 2014 | 18/3/2014 | Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) | Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis | Ulcerative Colitis | Drug: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 205 | Phase 4 | United Kingdom |
| 46 | EUCTR2013-004583-56-GB (EUCTR) | 28/01/2014 | 23/12/2013 | Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis | Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Simponi INN or Proposed INN: golimumab | MSD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 47 | EUCTR2012-004366-18-BE (EUCTR) | 08/01/2014 | 27/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 48 | EUCTR2012-004366-18-DE (EUCTR) | 17/12/2013 | 29/07/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany | ||
| 49 | EUCTR2012-004366-18-DK (EUCTR) | 11/12/2013 | 03/12/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands | ||
| 50 | NCT01988961 (ClinicalTrials.gov) | December 2013 | 14/11/2013 | A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Golimumab | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 103 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czech Republic;France;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine |
| 51 | EUCTR2012-004366-18-NL (EUCTR) | 28/11/2013 | 16/08/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands | ||
| 52 | NCT01900574 (ClinicalTrials.gov) | August 9, 2013 | 12/7/2013 | A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Janssen Research & Development, LLC | NULL | Completed | 2 Years | 17 Years | All | 35 | Phase 1 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland |
| 53 | EUCTR2012-004366-18-AT (EUCTR) | 30/07/2013 | 12/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 54 | NCT01804166 (ClinicalTrials.gov) | March 21, 2013 | 1/2/2013 | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | Hepatosplenic T-Cell Lymphoma | Drug: Infliximab;Drug: Golimumab | Janssen Scientific Affairs, LLC | NULL | Completed | N/A | N/A | All | 1 | Phase 4 | United States |
| 55 | NCT01863771 (ClinicalTrials.gov) | March 15, 2013 | 23/5/2013 | A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. | A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Other: Placebo | Janssen Pharmaceutical K.K. | NULL | Completed | 18 Years | 70 Years | All | 144 | Phase 3 | Japan |
| 56 | EUCTR2006-003398-28-CZ (EUCTR) | 24/05/2010 | 10/02/2010 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden | ||
| 57 | EUCTR2006-003399-37-CZ (EUCTR) | 24/05/2010 | 10/02/2010 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 58 | NCT05530122 (ClinicalTrials.gov) | January 2009 | 29/8/2022 | Prognosis in UC After First Biological | The Long-term Outcome of Patients With Ulcerative Colitis Treated With First Trial of Biological. | Ulcerative Colitis | Biological: infliximab, adalimumab, golimumab, vedolizumab, ustekinumab | Tampere University Hospital | NULL | Completed | 16 Years | N/A | All | 192 | NULL | |
| 59 | JPRN-JapicCTI-090740 | 08/12/2008 | 10/04/2009 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | NULL | 18 | BOTH | Phase 3 | NULL | |||
| 60 | JPRN-JapicCTI-090739 | 08/12/2008 | 10/04/2009 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | NULL | 18 | BOTH | Phase 2-3 | NULL | |||
| 61 | EUCTR2006-003397-94-SE (EUCTR) | 23/10/2008 | 21/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden | ||
| 62 | EUCTR2006-003399-37-DK (EUCTR) | 25/09/2008 | 10/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 63 | EUCTR2006-003398-28-DK (EUCTR) | 25/09/2008 | 04/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 64 | EUCTR2006-003398-28-SE (EUCTR) | 26/08/2008 | 21/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden | ||
| 65 | EUCTR2006-003399-37-SE (EUCTR) | 26/08/2008 | 21/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 66 | EUCTR2006-003398-28-BG (EUCTR) | 10/06/2008 | 30/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania | ||
| 67 | EUCTR2006-003399-37-BG (EUCTR) | 30/05/2008 | 30/04/2008 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 68 | EUCTR2006-003397-94-BG (EUCTR) | 30/05/2008 | 30/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania | ||
| 69 | EUCTR2006-003398-28-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 70 | EUCTR2006-003397-94-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 71 | EUCTR2006-003399-37-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 72 | EUCTR2006-003398-28-NL (EUCTR) | 17/01/2008 | 08/10/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 73 | EUCTR2006-003397-94-NL (EUCTR) | 17/01/2008 | 07/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 74 | EUCTR2006-003399-37-NL (EUCTR) | 17/01/2008 | 08/10/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 75 | EUCTR2006-003398-28-BE (EUCTR) | 10/12/2007 | 18/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 76 | EUCTR2006-003399-37-DE (EUCTR) | 27/11/2007 | 03/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 77 | EUCTR2006-003397-94-AT (EUCTR) | 15/11/2007 | 16/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 78 | EUCTR2006-003399-37-BE (EUCTR) | 15/11/2007 | 18/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 79 | EUCTR2006-003398-28-DE (EUCTR) | 15/11/2007 | 03/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 80 | EUCTR2006-003397-94-BE (EUCTR) | 15/11/2007 | 18/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 81 | EUCTR2006-003399-37-HU (EUCTR) | 30/10/2007 | 10/07/2007 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden | ||
| 82 | EUCTR2006-003397-94-HU (EUCTR) | 30/10/2007 | 10/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2;Phase 3 | Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden;France;Hungary;Slovakia;Belgium | ||
| 83 | EUCTR2006-003398-28-HU (EUCTR) | 29/10/2007 | 10/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 84 | EUCTR2006-003399-37-SK (EUCTR) | 04/10/2007 | 23/12/2009 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 85 | EUCTR2006-003398-28-SK (EUCTR) | 04/10/2007 | 23/12/2009 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2;Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 86 | EUCTR2006-003397-94-SK (EUCTR) | 04/10/2007 | 16/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden | ||
| 87 | EUCTR2006-003399-37-AT (EUCTR) | 27/09/2007 | 17/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 88 | EUCTR2006-003398-28-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 89 | EUCTR2006-003397-94-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden | ||
| 90 | EUCTR2006-003399-37-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 91 | EUCTR2006-003398-28-AT (EUCTR) | 06/09/2007 | 17/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 92 | EUCTR2006-003397-94-DE (EUCTR) | 05/09/2007 | 03/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 93 | EUCTR2006-003399-37-LV (EUCTR) | 03/09/2007 | 04/09/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan | ||
| 94 | EUCTR2006-003398-28-LV (EUCTR) | 03/09/2007 | 04/09/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 95 | EUCTR2006-003397-94-LV (EUCTR) | 03/09/2007 | 04/09/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 96 | NCT00488631 (ClinicalTrials.gov) | September 2007 | 18/6/2007 | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 1228 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom |
| 97 | NCT00487539 (ClinicalTrials.gov) | August 2007 | 14/6/2007 | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 1065 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom |
| 98 | NCT00488774 (ClinicalTrials.gov) | August 2007 | 18/6/2007 | An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Other: Placebo;Drug: Golimumab 1 mg per kg;Drug: Golimumab 2 mg per kg;Drug: Golimumab 4 mg per kg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Terminated | 18 Years | N/A | All | 291 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;France;Germany;Hungary;India;Israel;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Sweden;Ukraine;Former Serbia and Montenegro;United Kingdom |
| 99 | EUCTR2012-004366-18-FR (EUCTR) | 28/09/2015 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany |
107. 若年性特発性関節炎
臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
| 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 | NCT02277444 (ClinicalTrials.gov) | December 17, 2014 | 27/10/2014 | A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy | A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy | Arthritis, Juvenile | Drug: Golimumab;Drug: Methotrexate | Janssen Research & Development, LLC | NULL | Active, not recruiting | 2 Years | 17 Years | All | 130 | Phase 3 | United States;Argentina;Brazil;Canada;Chile;Israel;Mexico;Russian Federation;South Africa;Puerto Rico |
| 2 | EUCTR2009-015019-42-DE (EUCTR) | 10/05/2011 | 20/08/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands | |||
| 3 | EUCTR2009-015019-42-BE (EUCTR) | 04/04/2011 | 06/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany | ||
| 4 | NCT01230827 (ClinicalTrials.gov) | December 2010 | 28/10/2010 | A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard Therapy | Juvenile Idiopathic Arthritis | Drug: CNTO 148 (Golimumab);Drug: Placebo;Drug: Methotrexate | Janssen Research & Development, LLC | Schering-Plough | Terminated | 2 Years | 18 Years | All | 173 | Phase 3 | United States;Austria;Belgium;Brazil;Canada;Finland;Germany;Lithuania;Mexico;Netherlands;Poland;Russian Federation;Argentina |
| 5 | EUCTR2009-015019-42-FI (EUCTR) | 17/11/2010 | 27/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands | |||
| 6 | EUCTR2009-015019-42-LT (EUCTR) | 02/11/2010 | 17/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 7 | EUCTR2009-015019-42-AT (EUCTR) | 05/10/2010 | 01/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 8 | NCT04200833 (ClinicalTrials.gov) | March 1, 2010 | 6/8/2019 | Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab | Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab | JIA Associated Uveitis | Drug: Golimumab | Medical University of Graz | NULL | Completed | N/A | N/A | All | 10 | NULL | |
| 9 | EUCTR2009-015019-42-Outside-EU/EEA (EUCTR) | 08/03/2012 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 170 | Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico |
270. 慢性再発性多発性骨髄炎
臨床試験数 : 1 / 薬物数 : 10 - (DrugBank : 9) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 73
| 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 | NCT04725422 (ClinicalTrials.gov) | August 1, 2018 | 18/1/2021 | CHronic Nonbacterial Osteomyelitis International Registry (CHOIR) | CHronic Nonbacterial Osteomyelitis International Registry (CHOIR) | Chronic Nonbacterial Osteomyelitis;Chronic Recurrent Multifocal Osteomyelitis | Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Pamidronate;Drug: Zoledronic acid;Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab;Drug: Golimumab | Seattle Children's Hospital | Boston Children's Hospital, Boston, MA, USA;Hospital for Special Surgery, New York City, NY, USA;Joseph M Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, NJ, USA;Riley Children's Hospital, Indianapolis, IN, USA;University of North Carolina, Chapel Hill, NC, USA;Royal Children's Hospital, Melbourne, Australia;Hacettepe University, Ankara, Turkey;Bambino Gesù Children's Hospital, Rome, Italy;University of British Columbia, Vancouver, BC, Canada;Meyer Children's Hospital, Florence, Italy;Mansoura university, faculty of medicine, Egypt | Recruiting | N/A | 21 Years | All | 2000 | United States |
271. 強直性脊椎炎
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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 | NCT05164198 (ClinicalTrials.gov) | January 15, 2022 | 8/11/2021 | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Ankylosing Spondylitis;Axial Spondyloarthritis | Biological: Adalimumab and its biosimilars;Biological: Biological: Etanercept and its biosimilars;Biological: Golimumab;Biological: Infliximab biosimilar | Hanyang University Seoul Hospital | Linical Korea | Not yet recruiting | 18 Years | 65 Years | All | 448 | Phase 4 | NULL |
| 2 | NCT03733925 (ClinicalTrials.gov) | January 7, 2019 | 5/11/2018 | A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis | A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis | Spondylitis, Ankylosing;Arthritis, Psoriatic | Drug: Golimumab | Johnson & Johnson Private Limited | NULL | Completed | 18 Years | N/A | All | 100 | Phase 4 | India |
| 3 | NCT02758782 (ClinicalTrials.gov) | September 2016 | 20/4/2016 | NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis | COmparison of the Effect of Treatment With NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine Over Two Years in Patients With ankyLosing Spondylitis: a Randomized Controlled Multicentre Trial | Ankylosing Spondylitis | Biological: Golimumab;Drug: Celecoxib | Charite University, Berlin, Germany | NULL | Completed | 18 Years | N/A | All | 156 | Phase 4 | Germany |
| 4 | NCT03557853 (ClinicalTrials.gov) | June 2016 | 5/6/2018 | Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab | A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab) | Ankylosing Spondylitis;Coxitis | Drug: Golimumab Injection | MSD Pharmaceuticals LLC | NULL | Unknown status | 18 Years | N/A | All | 39 | Russian Federation | |
| 5 | 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 | ||
| 6 | EUCTR2014-000241-74-DE (EUCTR) | 30/12/2014 | 01/10/2014 | A Study of Golimumab in Participants with Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Ankylosing Spondylitis - GO - ALIVE | Ankylosing spondylitis (AS) MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: golimumab INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti-TNFa monoclonal antibody | Janssen Biologics, BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of | ||
| 7 | NCT02186873 (ClinicalTrials.gov) | September 3, 2014 | 8/7/2014 | A Study of Golimumab in Participants With Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Placebo;Drug: Golimumab | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania |
| 8 | NCT01668004 (ClinicalTrials.gov) | September 3, 2012 | 1/8/2012 | The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) | Open-Label, Phase 4 Study, Investigating the Incidence of Extra-Articular Manifestations in Subjects With Ankylosing Spondylitis Treated With Golimumab; Protocol No. MK-8259-012 | Ankylosing Spondylitis | Biological: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 101 | Phase 4 | Netherlands |
| 9 | EUCTR2012-002458-21-NL (EUCTR) | 23/07/2012 | 03/07/2012 | Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with Golimumab | Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab - GO-EASY | Ankylosing Spondylitis(Bechterew disease) MedDRA version: 14.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | MERCK SHARP & DOHME B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Netherlands | ||
| 10 | NCT01610947 (ClinicalTrials.gov) | May 14, 2012 | 24/5/2012 | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial | Spondyloarthritis | Drug: Adalimumab, Etanercept, Golimumab or infliximab | University Hospital, Montpellier | NULL | Completed | 18 Years | N/A | All | 398 | N/A | France |
| 11 | NCT01248793 (ClinicalTrials.gov) | October 2010 | 24/11/2010 | Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Placebo;Drug: Golimumab;Drug: Golimumab (placebo group) | Centocor, Inc. | NULL | Completed | 18 Years | N/A | All | 213 | Phase 3 | China |
| 12 | NCT01313858 (ClinicalTrials.gov) | April 2010 | 10/3/2011 | A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) | Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis | Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing | Drug: Simponi®;Drug: Methotrexate | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 1613 | N/A | Germany |
| 13 | NCT01081717 (ClinicalTrials.gov) | April 14, 2009 | 4/3/2010 | Golimumab Safety and Surveillance Program Using the Ingenix NHI Database | A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments | Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis | Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population | Janssen Biotech, Inc. | NULL | Completed | N/A | 99 Years | All | 1064 | United States | |
| 14 | EUCTR2004-003299-12-GB (EUCTR) | 11/10/2006 | 24/01/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | Ankylosing Spondylitis (AS) | Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | Finland;Belgium;Germany;United Kingdom | ||
| 15 | EUCTR2004-003299-12-FI (EUCTR) | 26/04/2006 | 28/12/2005 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | Ankylosing Spondylitis (AS) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Finland;United Kingdom;Germany;Belgium | |||
| 16 | EUCTR2004-003299-12-DE (EUCTR) | 04/04/2006 | 02/01/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | Ankylosing Spondylitis (AS) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Finland;United Kingdom;Germany;Belgium | |||
| 17 | EUCTR2004-003299-12-BE (EUCTR) | 20/03/2006 | 01/02/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA | Ankylosing Spondylitis (AS) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | Finland;Belgium;Germany;United Kingdom | ||
| 18 | NCT00265083 (ClinicalTrials.gov) | December 2005 | 12/12/2005 | A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: golimumab;Biological: Golimumab (CNTO 148); placebo | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 356 | Phase 3 | United States;Belgium;Canada;Finland;France;Germany;Korea, Republic of;Netherlands;Taiwan;United Kingdom |