46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | JPRN-jRCTs071190030 | 28/07/2020 | 11/10/2019 | Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments | Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments | Rheumatoid arthritis | Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade. The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade. | Kawakami Atsushi | NULL | Recruiting | >= 20age old | Not applicable | Both | 80 | Phase 4 | Japan |
| 2 | NCT04779892 (ClinicalTrials.gov) | February 1, 2020 | 26/2/2021 | The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety | The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety | Rheumatoid Arthritis | Drug: Infliximab | Taizhou Mabtech Pharmaceutical Co.,Ltd | NULL | Completed | 18 Years | 45 Years | Male | 90 | Phase 1 | China |
| 3 | NCT03707535 (ClinicalTrials.gov) | November 12, 2018 | 12/10/2018 | To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: CT-P13;Biological: Remicade | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 270 | Phase 3 | China |
| 4 | NCT03478111 (ClinicalTrials.gov) | March 30, 2018 | 16/3/2018 | CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis | A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade | Rheumatoid Arthritis | Drug: CMAB008;Drug: MTX;Drug: Remicade | Shanghai Biomabs Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 390 | Phase 3 | China |
| 5 | EUCTR2016-001987-12-IT (EUCTR) | 18/08/2017 | 05/01/2021 | Clinical study aimed to compare tocilizumab to anti-TNF treatment and to discover biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF | Open-label, randomized controlled trial comparing tocilizumab to anti-TNF treatment and discovery of biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF - RAFTING | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039014;Term: Rh arthritis;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO Product Name: Tocilizumab Product Code: [NA] INN or Proposed INN: Tocilizumab Other descriptive name: Tocilizumab Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: etanercept Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: Infliximab Product Code: [NA] INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI | SOCIETA' ITALIANA DI REUMATOLOGIA - SIR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 4 | Italy | ||
| 6 | EUCTR2016-001064-11-GB (EUCTR) | 18/07/2017 | 31/03/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 7 | EUCTR2016-001064-11-CZ (EUCTR) | 20/04/2017 | 31/03/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 8 | EUCTR2016-001064-11-PL (EUCTR) | 13/04/2017 | 12/04/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom | ||
| 9 | EUCTR2016-001064-11-ES (EUCTR) | 07/04/2017 | 07/04/2017 | Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis | A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 19.1;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: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 10 | 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 | ||
| 11 | EUCTR2014-004704-29-DE (EUCTR) | 19/12/2016 | 23/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 12 | EUCTR2014-004704-29-CZ (EUCTR) | 15/12/2016 | 02/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 13 | NCT02990806 (ClinicalTrials.gov) | December 2016 | 21/11/2016 | A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE) | A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis | Rheumatoid Arthritis (RA) | Biological: NI-071;Biological: Infliximab | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 683 | Phase 3 | United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom |
| 14 | EUCTR2014-004704-29-BG (EUCTR) | 29/11/2016 | 15/09/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 15 | EUCTR2014-004704-29-PL (EUCTR) | 25/11/2016 | 04/10/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany | ||
| 16 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 17 | EUCTR2014-004704-29-HU (EUCTR) | 05/10/2016 | 08/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 18 | EUCTR2014-004704-29-ES (EUCTR) | 03/10/2016 | 05/08/2016 | This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine. | A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable | 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] | Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 19 | EUCTR2014-004904-31-BE (EUCTR) | 21/09/2016 | 29/07/2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | ||
| 20 | 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 | |
| 21 | NCT02683564 (ClinicalTrials.gov) | February 2016 | 9/2/2016 | BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study | A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study | Rheumatoid Arthritis | Drug: BOW015;Drug: Remicade | Epirus Biopharmaceuticals (Switzerland) GmbH | NULL | Not yet recruiting | 18 Years | 80 Years | Both | 548 | Phase 3 | NULL |
| 22 | NCT02762838 (ClinicalTrials.gov) | January 2016 | 4/4/2016 | Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acid | Biocad | NULL | Completed | 18 Years | 75 Years | All | 426 | Phase 3 | Belarus;India;Russian Federation |
| 23 | EUCTR2015-004173-32-DK (EUCTR) | 18/12/2015 | 20/10/2015 | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. | Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study. | Rheumatic diseases MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Benepali INN or Proposed INN: ETANERCEPT Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Department of Clinical Biochemestry, Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Denmark | ||
| 24 | EUCTR2015-000581-58-CZ (EUCTR) | 14/10/2015 | 16/06/2015 | A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB | Revmatologicky ustav Praha | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Czech Republic | ||
| 25 | 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 | ||
| 26 | NCT02605642 (ClinicalTrials.gov) | September 10, 2015 | 2/9/2015 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade | PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB) | Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: CT-P13 | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Completed | 18 Years | N/A | All | 351 | Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy | |
| 27 | EUCTR2014-004904-31-NL (EUCTR) | 19/05/2015 | 26/01/2015 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 28 | NCT02353780 (ClinicalTrials.gov) | March 2015 | 30/6/2013 | Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept | Mechanistic Studies of B- and T-Cell Function in Rheumatoid Arthritis Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept | Rheumatoid Arthritis (RA) | Drug: TNF Antagonist (enbrel, humire, remicade, cimzia, symponi);Drug: Abatacept;Drug: Tocilizumab | Dr. Larry W. Moreland | Genentech, Inc.;Bristol-Myers Squibb | Terminated | 18 Years | 64 Years | All | 10 | Phase 4 | United States |
| 29 | EUCTR2013-004148-49-FR (EUCTR) | 23/02/2015 | 18/06/2015 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 30 | EUCTR2013-004148-49-PL (EUCTR) | 21/10/2014 | 27/08/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | 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] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Georgia;Germany;Japan | ||
| 31 | EUCTR2013-004148-49-BG (EUCTR) | 20/10/2014 | 01/09/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 19.1;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: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia | ||
| 32 | EUCTR2013-004148-49-HU (EUCTR) | 13/08/2014 | 06/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 33 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 34 | EUCTR2013-004148-49-DE (EUCTR) | 28/07/2014 | 06/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany | ||
| 35 | EUCTR2013-004148-49-LT (EUCTR) | 14/07/2014 | 23/05/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina | ||
| 36 | EUCTR2013-004148-49-GB (EUCTR) | 03/07/2014 | 06/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | 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] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 37 | EUCTR2013-004148-49-CZ (EUCTR) | 20/06/2014 | 05/06/2014 | RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS | A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 614 | Phase 3 | United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan | ||
| 38 | 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 |
| 39 | EUCTR2012-005733-37-GB (EUCTR) | 18/09/2013 | 23/07/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | 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: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 40 | EUCTR2012-005733-37-CZ (EUCTR) | 16/08/2013 | 15/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 17.0;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: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 41 | EUCTR2012-005733-37-LV (EUCTR) | 02/08/2013 | 22/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | 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: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | |||
| 42 | NCT01936181 (ClinicalTrials.gov) | August 2013 | 2/9/2013 | A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab) | Samsung Bioepis Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 584 | Phase 3 | Bulgaria;Lithuania |
| 43 | EUCTR2012-005733-37-LT (EUCTR) | 11/07/2013 | 20/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 17.0;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: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | |||
| 44 | EUCTR2012-005733-37-BG (EUCTR) | 10/07/2013 | 21/05/2013 | A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Rheumatoid Arthritis MedDRA version: 17.0;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: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 45 | EUCTR2012-005275-14-NO (EUCTR) | 19/03/2013 | 04/02/2013 | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs | Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND | Rheumatoid arthritis (RA) 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] | Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning. Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Norway | |||
| 46 | 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 | ||
| 47 | EUCTR2012-000139-21-AT (EUCTR) | 14/05/2012 | 23/04/2012 | Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB | Medizinische Universität Wien, Universitätsklinik für Innere Medizin III | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Czech Republic;Slovakia;Austria;Russian Federation;Switzerland | |||
| 48 | NCT01638715 (ClinicalTrials.gov) | May 2012 | 3/7/2012 | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action | Rheumatoid Arthritis | Drug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: Mabthera | Medical University of Vienna | NULL | Completed | 18 Years | 75 Years | All | 115 | Phase 4 | Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia |
| 49 | EUCTR2011-004468-31-LT (EUCTR) | 14/03/2012 | 05/01/2012 | Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | |||
| 50 | NCT01571219 (ClinicalTrials.gov) | March 2012 | 23/3/2012 | An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1 | Rheumatoid Arthritis | Biological: Infliximab | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 302 | Phase 3 | Korea, Republic of;United Kingdom |
| 51 | EUCTR2011-004468-31-ES (EUCTR) | 10/02/2012 | 07/12/2011 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | ||
| 52 | EUCTR2011-004468-31-PL (EUCTR) | 07/02/2012 | 10/02/2012 | Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | |||
| 53 | EUCTR2011-004468-31-LV (EUCTR) | 06/02/2012 | 30/12/2011 | Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | |||
| 54 | EUCTR2011-004468-31-IT (EUCTR) | 02/02/2012 | 02/03/2012 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13-3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Other descriptive name: NA | CELLTRION, INC. | NULL | Not Recruiting | Female: yes Male: yes | 617 | Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina | |||
| 55 | NCT01567358 (ClinicalTrials.gov) | February 2012 | 23/3/2012 | Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis | A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate | Rheumatoid Arthritis | Biological: Infliximab | Nichi-Iko Pharmaceutical Co.,Ltd. | NULL | Completed | 20 Years | 75 Years | Both | 14 | Phase 1 | Japan |
| 56 | EUCTR2011-004468-31-AT (EUCTR) | 26/01/2012 | 30/11/2011 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 522 | Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Jordan;Poland | |||
| 57 | EUCTR2011-004468-31-GB (EUCTR) | 06/01/2012 | 25/11/2011 | Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 617 | Phase 3 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | ||
| 58 | EUCTR2011-004468-31-SK (EUCTR) | 30/12/2011 | 04/01/2012 | Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | ||||
| 59 | EUCTR2010-023880-17-GB (EUCTR) | 31/03/2011 | 25/02/2011 | SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug | SWITCH: 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. - SWITCH | Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Mabthera Product Name: Rituximab Product Code: n/a INN or Proposed INN: Rituximab Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of the world) Trade Name: Orencia Product Name: Abatacept Product Code: n/a INN or Proposed INN: abatacept Other descriptive name: Orencia Trade Name: Remicade Product Name: Infliximab Product Code: n/a INN or Proposed INN: infliximab Other descriptive name: n/a Trade Name: Enbrel Product Name: Etanercept Product Code: n/a INN or Proposed INN: etanercept Other descriptive name: n/a | University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 477 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 60 | EUCTR2010-018646-31-LT (EUCTR) | 30/11/2010 | 06/08/2010 | CT-P13 Compared With Remicade When Co-Administered With Methotrexate | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 13.1;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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;Colombia;Bulgaria;Chile;Indonesia;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Russian Federation;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan | ||
| 61 | EUCTR2010-018646-31-ES (EUCTR) | 05/11/2010 | 12/08/2010 | Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | Artritis reumatoide.Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom | ||
| 62 | EUCTR2010-018646-31-LV (EUCTR) | 11/10/2010 | 29/06/2010 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 633 | Phase 3 | Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania | |||
| 63 | EUCTR2010-018646-31-SK (EUCTR) | 11/10/2010 | 23/06/2010 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom | ||
| 64 | EUCTR2010-018646-31-BG (EUCTR) | 07/10/2010 | 07/09/2010 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom | ||
| 65 | EUCTR2010-018646-31-PT (EUCTR) | 01/10/2010 | 23/07/2010 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom | ||
| 66 | EUCTR2010-018646-31-AT (EUCTR) | 29/09/2010 | 03/08/2010 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - | 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: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania | |||
| 67 | EUCTR2010-018646-31-IT (EUCTR) | 14/09/2010 | 26/07/2010 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - ND | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073 | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade INN or Proposed INN: Infliximab | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania | |||
| 68 | EUCTR2010-018646-31-GB (EUCTR) | 09/09/2010 | 22/07/2010 | A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis | Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB | CELLTRION, Inc | NULL | Not Recruiting | Female: yes Male: yes | 633 | Phase 3 | Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania | |||
| 69 | 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 | ||
| 70 | EUCTR2007-003288-36-GB (EUCTR) | 04/11/2009 | 03/10/2008 | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 71 | EUCTR2008-005450-20-BE (EUCTR) | 29/10/2009 | 01/10/2009 | The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME) | The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME) | Rheumatoid arthritis MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade (infliximab) INN or Proposed INN: INFLIXIMAB Other descriptive name: remicade Trade Name: Humira (adalimumab) INN or Proposed INN: ADALIMUMAB Trade Name: Enbrel (etanercept) INN or Proposed INN: ETANERCEPT Other descriptive name: Enbrel Trade Name: Mabthera (rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: Mabthera Trade Name: Orencia (abatacept) INN or Proposed INN: ABATACEPT Other descriptive name: Orencia | Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Belgium | |||
| 72 | EUCTR2007-003288-36-ES (EUCTR) | 08/01/2009 | 09/03/2010 | Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART | Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART | Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria | |||
| 73 | EUCTR2007-003288-36-FR (EUCTR) | 08/12/2008 | 21/10/2008 | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 74 | EUCTR2007-003288-36-FI (EUCTR) | 28/11/2008 | 30/09/2008 | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria | ||
| 75 | EUCTR2008-006256-22-FR (EUCTR) | 21/11/2008 | 31/10/2008 | Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy. | Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy. | rheumatoid arthritis requiring anti-TNF alpha treatment MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions | Trade Name: remicade INN or Proposed INN: infliximab Trade Name: humira INN or Proposed INN: adalimumab Trade Name: enbrel INN or Proposed INN: etanercept | CHU Saint-Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 76 | EUCTR2007-003288-36-DE (EUCTR) | 10/11/2008 | 03/09/2008 | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria | ||
| 77 | NCT00948610 (ClinicalTrials.gov) | November 2008 | 28/7/2009 | Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy | Sleep & Immune Mechanisms in Rheumatoid Arthritis: Remicade Substudy | Rheumatoid Arthritis | Drug: Remicade | University of California, Los Angeles | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | 85 Years | All | 20 | N/A | United States |
| 78 | EUCTR2007-003288-36-NL (EUCTR) | 15/10/2008 | 11/07/2008 | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria | ||
| 79 | EUCTR2008-005212-40-SE (EUCTR) | 14/10/2008 | 14/08/2008 | Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING | Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING | Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10060016;Term: Alpha tumor necrosis factor MedDRA version: 9.1;Classification code 10029817;Term: Nuclear magnetic resonance imaging brain MedDRA version: 9.1;Classification code 10053689;Term: Cardiovascular autonomic function test | Trade Name: Remicade INN or Proposed INN: Infliximab | Karolinska Institute | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | Sweden | ||||
| 80 | EUCTR2007-003288-36-AT (EUCTR) | 01/10/2008 | 18/08/2008 | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1 | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria | ||
| 81 | NCT00714493 (ClinicalTrials.gov) | July 2008 | 10/7/2008 | RESTART C0168Z05 Rheumatoid Arthritis Study | A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA). | Rheumatoid Arthritis | Biological: Infliximab | Centocor Ortho Biotech Services, L.L.C. | Schering-Plough | Completed | 18 Years | N/A | All | 203 | Phase 4 | United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium |
| 82 | EUCTR2007-005464-26-GB (EUCTR) | 05/06/2008 | 11/04/2008 | Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body. | The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II | Rheumatoid Arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;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 Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Kings College London | Guys and St Thomas'NHS Foundation Trust | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 83 | NCT00741104 (ClinicalTrials.gov) | January 2008 | 30/7/2008 | A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417) | A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients | Rheumatoid Arthritis | Drug: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | N/A | N/A | All | 363 | NULL | |
| 84 | NCT01245361 (ClinicalTrials.gov) | November 2007 | 19/11/2010 | A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit | A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. | Undifferentiated Arthritis | Drug: Infliximab;Drug: sodium chloride | Patrick Durez | NULL | Completed | N/A | N/A | Both | 30 | N/A | Belgium |
| 85 | EUCTR2007-004694-26-BE (EUCTR) | 17/09/2007 | 10/09/2007 | A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA | A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA | Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: REMICADE® (Infliximab) Product Code: - | Saint-Luc Universitary Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Belgium | |||
| 86 | EUCTR2007-002752-42-FR (EUCTR) | 13/09/2007 | 23/07/2007 | FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR | FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR | Polyarthrite rhumatoïde MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade® INN or Proposed INN: INFLIXIMAB | CHRU de Tours | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 87 | EUCTR2005-001889-13-DE (EUCTR) | 09/07/2007 | 21/12/2006 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab | Schering-Plough Research Institute (SPRI) | NULL | Not Recruiting | Female: yes Male: yes | 315 | Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden | |||
| 88 | NCT00760669 (ClinicalTrials.gov) | May 2007 | 24/9/2008 | An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants | Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients | Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic | Drug: Infliximab; observational study;Drug: Methotrexate | Janssen Korea, Ltd., Korea | NULL | Completed | N/A | N/A | All | 1061 | Korea, Republic of | |
| 89 | EUCTR2005-001889-13-FR (EUCTR) | 27/12/2006 | 30/11/2006 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up | Trade Name: Remicade INN or Proposed INN: Infliximab | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Portugal;France;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 90 | EUCTR2006-004673-98-HU (EUCTR) | 16/10/2006 | 08/09/2006 | Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker | Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker | To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index. | Trade Name: MabThera 500 mg concentrate for solution for infusion | Roche (Hungary) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Hungary | |||
| 91 | EUCTR2006-000363-28-GB (EUCTR) | 03/10/2006 | 28/04/2006 | DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study | DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study | Rheumatoid arthritis and Psoriatic arthritis | Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: Etanercept | Greater Glasgow Health Board | Glasgow University | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 92 | EUCTR2005-001889-13-NL (EUCTR) | 13/07/2006 | 20/04/2006 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up | Trade Name: Remicade | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 93 | EUCTR2005-001889-13-DK (EUCTR) | 04/05/2006 | 16/03/2006 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up | Trade Name: Remicade | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Portugal;Germany;Netherlands;Belgium;Denmark;France;Greece;Sweden | |||
| 94 | EUCTR2005-001889-13-GR (EUCTR) | 02/05/2006 | 23/05/2006 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Remicade | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 95 | EUCTR2005-001633-14-SE (EUCTR) | 11/04/2006 | 27/02/2006 | Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study | Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study | Rheumatoid arthritis | Trade Name: Humira Product Name: Humira Trade Name: Remicade Product Name: Remicade | Hvidovre Hospital, Dept. Rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Denmark;Sweden | |||
| 96 | EUCTR2005-001889-13-PT (EUCTR) | 07/04/2006 | 17/01/2006 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab | Schering Plough Research Institute, a Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 315 | Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden | |||
| 97 | EUCTR2005-005013-37-GB (EUCTR) | 06/04/2006 | 20/01/2006 | A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA | A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA | Early Rheumatoid Arthritis | Trade Name: Remicade Product Name: Remicade Product Code: Infliximab Trade Name: Mextrex Product Name: Methotrexate Product Code: Mextrex INN or Proposed INN: n/a Other descriptive name: Methotrexate Trade Name: Ferrograd Folic Tablets Product Name: Folic Acid Product Code: Ferrograd INN or Proposed INN: n/a Other descriptive name: Folic Acid Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram INN or Proposed INN: n/a Other descriptive name: Methylprednisolone Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram INN or Proposed INN: n/a | University of Leeds | NULL | Not Recruiting | 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 | ||
| 98 | EUCTR2005-001889-13-BE (EUCTR) | 06/03/2006 | 19/12/2005 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab | Schering Plough Research Institute, a Division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 315 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 99 | NCT00394589 (ClinicalTrials.gov) | March 2006 | 31/10/2006 | Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3) | Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice. | Rheumatoid Arthritis | Drug: Infliximab Control;Drug: Infliximab Increased Frequency;Drug: Infliximab Increased Dose | Merck Sharp & Dohme Corp. | Integrated Therapeutics Group | Terminated | 18 Years | N/A | All | 43 | Phase 3 | Austria;Belgium;Denmark;France;Germany;Netherlands;Sweden;Turkey |
| 100 | NCT00724243 (ClinicalTrials.gov) | January 2006 | 25/7/2008 | Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED) | Remicade Treatment Registry in Rheumatoid Arthritis I | Rheumatoid Arthritis | Drug: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | N/A | N/A | All | 33 | N/A | Slovakia |
| 101 | EUCTR2005-004530-40-AT (EUCTR) | 30/12/2005 | 25/11/2005 | Induction of remission in RA patients at low disease activity by additional Infliximab-therapy | Induction of remission in RA patients at low disease activity by additional Infliximab-therapy | Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion. | Trade Name: Remicade Product Name: Remicade | AESCA Pharma Ges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 160 | Austria | |||
| 102 | EUCTR2005-001889-13-SE (EUCTR) | 24/11/2005 | 13/10/2005 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3 | Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 315 | Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden | |||
| 103 | EUCTR2005-001889-13-AT (EUCTR) | 15/09/2005 | 08/11/2005 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3 | Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. | Trade Name: Remicade Product Name: Remicade | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | |||
| 104 | EUCTR2005-001633-14-DK (EUCTR) | 17/08/2005 | 30/06/2005 | Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study | Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study | Rheumatoid arthritis | Trade Name: Humira Product Name: Humira Trade Name: Remicade Product Name: Remicade | Hvidovre Hospital, Dept. Rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Denmark;Sweden | |||
| 105 | NCT00202852 (ClinicalTrials.gov) | June 1, 2005 | 13/9/2005 | A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED) | A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate | Arthritis, Rheumatoid | Other: Placebo;Drug: MTX;Biological: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 75 Years | All | 143 | Phase 3 | Korea, Republic of |
| 106 | EUCTR2004-000922-59-CZ (EUCTR) | 15/03/2005 | 15/03/2005 | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate | Rheumatoid Arthrithis, Nos | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Czech Republic;Denmark;Spain;Sweden | ||
| 107 | EUCTR2004-000922-59-DK (EUCTR) | 02/02/2005 | 01/12/2004 | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate | Rheumatoid Arthrithis, Nos | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Czech Republic;Denmark;Spain;Sweden | ||
| 108 | EUCTR2004-000922-59-ES (EUCTR) | 21/12/2004 | 18/05/2005 | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate | Rheumatoid Arthrithis, Nos | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Czech Republic;Spain;Denmark;Sweden | ||
| 109 | EUCTR2005-000492-18-IT (EUCTR) | 16/12/2004 | 09/11/2007 | Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome | Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome | Metabolic Syndrome and Rheumatoid Arthritis MedDRA version: 6.1;Level: SOC;Classification code 10021428 | Trade Name: REMICADE*EV F 100MG+F 2ML INN or Proposed INN: Infliximab | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 110 | EUCTR2004-000922-59-SE (EUCTR) | 01/12/2004 | 13/10/2004 | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006). | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006). | Rheumatoid Arthrithis, Nos | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Czech Republic;Denmark;Spain;Sweden | ||
| 111 | NCT00236028 (ClinicalTrials.gov) | November 2004 | 7/10/2005 | A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis | A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Infliximab | Centocor, Inc. | NULL | Completed | 18 Years | 75 Years | Both | 607 | Phase 3 | NULL |
| 112 | NCT00099554 (ClinicalTrials.gov) | May 2004 | 16/12/2004 | Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab) | A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab) | Rheumatoid Arthritis | Drug: Etanercept | Amgen | NULL | Completed | 18 Years | N/A | Both | 200 | Phase 4 | United States;Canada |
| 113 | NCT00725621 (ClinicalTrials.gov) | March 2004 | 25/7/2008 | Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED) | Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy | Rheumatoid Arthritis | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | N/A | N/A | All | 516 | N/A | Austria |
| 114 | NCT00794898 (ClinicalTrials.gov) | July 1, 2003 | 19/11/2008 | Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027) | Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment | Arthritis, Rheumatoid | Biological: Infliximab (Remicade) | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 75 Years | All | 19 | Phase 4 | NULL |
| 115 | NCT00036387 (ClinicalTrials.gov) | October 2001 | 9/5/2002 | A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis. | A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy. | Arthritis, Rheumatoid | Drug: Infliximab | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 347 | Phase 3 | United States |
| 116 | NCT00036374 (ClinicalTrials.gov) | October 2001 | 9/5/2002 | A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis | A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis | Rheumatoid Arthritis, Juvenile | Drug: Infliximab | Centocor, Inc. | NULL | Completed | 4 Years | 18 Years | Both | 123 | Phase 3 | United States |