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 | NCT05246293 (ClinicalTrials.gov) | March 2, 2022 | 17/1/2022 | Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease. | Safety and Tolerability of Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease (RAILDTo Trial). | Rheumatoid Arthritis;Interstitial Lung Disease | Drug: Tofacitinib | National Institute of Respiratory Diseases, Mexico | NULL | Not yet recruiting | 18 Years | N/A | All | 60 | Phase 2 | Mexico |
| 2 | EUCTR2021-004131-84-NL (EUCTR) | 14/02/2022 | 08/09/2021 | Comparing the effectiveness of tofacitinib extended release (XR) chronotherapy, morning versus evening dosing, in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients from a patient’s, clinical as well as a translational point of view. | Chronotherapy in Inflammatory Arthritis (ChronIA trial): a crossover randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release - ChronIA trial | Rheumatoid arthritis or psoriatic arthritis according to respectively 2010 criteria or CASPAR criteria MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz XR Product Name: Tofacitinib XR Product Code: EMEA/H/C/004214 | Erasmus Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 4 | Netherlands | ||
| 3 | NCT05133297 (ClinicalTrials.gov) | January 2022 | 15/11/2021 | The Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis | A Phase 2A, Randomized, Double-blind, Double-dummy, Tofacitinib-parallel-group Study to Evaluate the Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Methotrexate. | Rheumatoid Arthritis | Drug: TLL-018;Drug: Tofacitinib | Hangzhou Highlightll Pharmaceutical Co., Ltd | NULL | Recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | China |
| 4 | NCT04876781 (ClinicalTrials.gov) | November 1, 2021 | 20/4/2021 | Korean Post-marketing Surveillance for Xeljanz XR | Korean Post-marketing Surveillance for Xeljanz XR (Registered) | Active Moderate to Severe Rheumatoid Arthritis;Active Ankylosing Spondylitis | Drug: Tofacitinib XR | Pfizer | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | NULL | |
| 5 | NCT05080218 (ClinicalTrials.gov) | October 2021 | 6/10/2021 | COVID-19 VaccinE Response in Rheumatology Patients | The SARS-CoV-2 Vaccine Response and Safety in Rheumatology Patients and the Influence of Temporary Interruptions in Immunomodulatory Therapy | Rheumatoid Arthritis;Psoriatic Arthritis;Spondylarthritis | Drug: Upadacitinib;Drug: Abatacept;Drug: Secukinumab;Drug: Tofacitinib;Drug: TNF Inhibitor;Drug: Canakinumab Injection | Jeffrey Curtis | University of Alabama at Birmingham;University of Nebraska;University of Pennsylvania;AbbVie;Bristol-Myers Squibb;Novartis;Eli Lilly and Company;Pfizer | Not yet recruiting | 18 Years | 85 Years | All | 1000 | Phase 4 | United States |
| 6 | EUCTR2021-001560-14-ES (EUCTR) | 13/08/2021 | 11/06/2021 | Use of tofacitinib in patients with treatment-refractory rheumatoid arthritis. | Single-center, open-label, uncontrolled clinical trial to evaluate the association between the expression of the JAK / STAT pathway and the response to tofacitinib in patients with refractory rheumatoid arthritis. | Refractory rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ INN or Proposed INN: TOFACITINIB | FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 4 | Spain | ||
| 7 | ChiCTR2100048185 | 2021-07-01 | 2021-07-04 | The efficacy and safety of Tofacitinib in the treatment of DMARDS naive rheumatoid arthtits patients | The efficacy and safety of Tofacitinib virus MTX in the treatment of DMARDS naive rheumatoid arthtits patients--a randomized controlled trial | Rheumatoid Arthritis | Experimental group:Tofacitinib 5mg twice per day;Control group:Methotrexate; | Peking University First Hospital | NULL | Pending | 18 | Both | Experimental group:112;Control group:112; | Phase 4 | China | |
| 8 | NCT04927000 (ClinicalTrials.gov) | May 31, 2021 | 31/5/2021 | The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis | The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tofacitinib | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 30 Years | 65 Years | Female | 170 | Phase 4 | China |
| 9 | NCT04798287 (ClinicalTrials.gov) | March 10, 2021 | 11/3/2021 | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: TNF Inhibitor | Brigham and Women's Hospital | NULL | Active, not recruiting | 18 Years | N/A | All | 105711 | United States | |
| 10 | NCT04772248 (ClinicalTrials.gov) | February 22, 2021 | 23/2/2021 | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: TNF Inhibitor | Brigham and Women's Hospital | NULL | Completed | 18 Years | N/A | All | 105711 | United States | |
| 11 | NCT04530305 (ClinicalTrials.gov) | January 7, 2021 | 24/8/2020 | Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor | Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor | Rheumatoid Arthritis | Drug: Tofacitinib 5 MG [Xeljanz] | University Hospital, Montpellier | NULL | Recruiting | 18 Years | N/A | All | 60 | France | |
| 12 | NCT04311567 (ClinicalTrials.gov) | November 7, 2020 | 5/3/2020 | Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease | Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial | Rheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILD | Drug: Tofacitinib;Drug: Methotrexate | Vastra Gotaland Region | Göteborg University | Recruiting | 18 Years | 80 Years | All | 48 | Phase 4 | Sweden |
| 13 | EUCTR2019-002676-14-SE (EUCTR) | 26/08/2020 | 14/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina | ||
| 14 | EUCTR2019-002676-14-BG (EUCTR) | 20/08/2020 | 27/05/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600 (Ritlecitinib) AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: Ritlecitinib/JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 15 | NCT04529876 (ClinicalTrials.gov) | August 17, 2020 | 25/8/2020 | Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tofacitinib vs Abatacept | Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tofacitinib vs Abatacept | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: Abatacept | Brigham and Women's Hospital | National Institute on Aging (NIA);Rutgers University;Johns Hopkins University | Completed | 18 Years | N/A | All | 29464 | United States | |
| 16 | NCT04413617 (ClinicalTrials.gov) | July 29, 2020 | 19/5/2020 | TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Drug: PF-06650833;Drug: PF-06651600;Drug: Tofacitinib | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 460 | Phase 2 | Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine;Bosnia and Herzegovina;Colombia;Sweden |
| 17 | EUCTR2019-002676-14-SK (EUCTR) | 27/07/2020 | 27/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz® 11mg Prolonged Release Tablet INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Ritlecitinib Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina | ||
| 18 | EUCTR2019-002676-14-CZ (EUCTR) | 07/07/2020 | 11/05/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB), AND TOFACITINIB ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina | ||
| 19 | EUCTR2019-002676-14-HU (EUCTR) | 18/06/2020 | 14/04/2020 | A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS | A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Bosnia and Herzegovina;Sweden;Georgia;Bulgaria;Romania;Poland;Canada;Mexico;Czech Republic;Hungary;Colombia;Russian Federation;Chile;Ukraine;Spain;Slovakia;Serbia | ||
| 20 | NCT04449224 (ClinicalTrials.gov) | April 27, 2020 | 7/6/2020 | Comparative Effectiveness of Targeted Therapy in RA Patients | Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study | Rheumatoid Arthritis | Drug: Adalimuab, Etanercept, Tocilizumab, or Abatacept;Drug: Tofacitinib or Baricitinib | Hanyang University | Ministry of Health, Republic of Korea | Recruiting | 19 Years | N/A | All | 506 | Korea, Republic of | |
| 21 | EUCTR2019-000867-26-DE (EUCTR) | 08/04/2020 | 04/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 22 | NCT04928066 (ClinicalTrials.gov) | March 1, 2020 | 9/6/2021 | The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA | Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: Tofacitinib;Drug: Pred | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | Phase 4 | China |
| 23 | NCT03976245 (ClinicalTrials.gov) | March 2020 | 3/6/2019 | Advanced Therapeutics in Rheumatoid Arthritis (RA) | Advanced Therapeutics in Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Etanercept;Drug: tofacitinib | Lawson Health Research Institute | Academic Medical Organization of Southwestern Ontario | Recruiting | 18 Years | N/A | All | 144 | Phase 4 | Canada |
| 24 | NCT04175886 (ClinicalTrials.gov) | February 25, 2020 | 20/11/2019 | Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project | Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project | Rheumatoid Arthritis | Drug: Tofacitinib | University Hospital, Lille | Pfizer | Recruiting | 18 Years | N/A | All | 72 | France | |
| 25 | EUCTR2019-004179-38-SE (EUCTR) | 10/01/2020 | 19/11/2019 | Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis | Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA | Patients with early active rheumatoid arthritis MedDRA version: 20.0;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: Xeljanz Trade Name: Metotrexat Orion | Västra Götalandsregionen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Sweden | ||
| 26 | EUCTR2019-000797-39-IT (EUCTR) | 20/12/2019 | 24/05/2021 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severelyactive rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Xeljanz Product Name: Tofacitinib Product Code: [Tofacitinib] INN or Proposed INN: Tofacitinib citrate Product Name: GSK3196165 Product Code: [GSK3196165] INN or Proposed INN: Otilimab | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;Sweden | ||
| 27 | EUCTR2019-000867-26-GB (EUCTR) | 10/12/2019 | 12/06/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 21.0;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: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of | ||
| 28 | EUCTR2019-000797-39-GB (EUCTR) | 22/11/2019 | 10/06/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;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: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation | ||
| 29 | EUCTR2019-000797-39-PL (EUCTR) | 18/11/2019 | 15/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anit human granulocyt-macrophage colony-stimulating factor (GM-CSF)monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF)monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 30 | EUCTR2019-000867-26-PL (EUCTR) | 15/11/2019 | 15/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of | ||
| 31 | EUCTR2019-000797-39-ES (EUCTR) | 14/11/2019 | 09/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | 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 Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 32 | EUCTR2019-000867-26-ES (EUCTR) | 14/11/2019 | 09/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | 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 Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 33 | NCT04485325 (ClinicalTrials.gov) | November 4, 2019 | 30/4/2020 | Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients | Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte) | Rheumatic Arthritis | Drug: Tofacitinib;Biological: Etanercept | Dr. Frank Behrens | Pfizer | Recruiting | 18 Years | 65 Years | All | 192 | Phase 4 | Germany |
| 34 | EUCTR2019-000797-39-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;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: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China | ||
| 35 | EUCTR2019-000867-26-HU (EUCTR) | 24/10/2019 | 28/10/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis MedDRA version: 21.0;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: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 36 | EUCTR2019-000797-39-LT (EUCTR) | 11/10/2019 | 19/07/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Czechia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 37 | EUCTR2019-000867-26-BG (EUCTR) | 11/10/2019 | 30/07/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2 | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 38 | EUCTR2019-000867-26-EE (EUCTR) | 10/10/2019 | 01/08/2019 | Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Phase 3 | United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 39 | EUCTR2019-000797-39-CZ (EUCTR) | 19/09/2019 | 18/09/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;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 Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China | ||
| 40 | EUCTR2019-000797-39-LV (EUCTR) | 13/09/2019 | 25/06/2019 | Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. | A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1 | Rheumatoid Arthritis MedDRA version: 21.0;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: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China | ||
| 41 | NCT04464642 (ClinicalTrials.gov) | July 10, 2019 | 6/7/2020 | Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis | Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Tofacitinib | Dr. Mohammad Mamun Khan | NULL | Active, not recruiting | 18 Years | N/A | All | 110 | Phase 4 | Bangladesh |
| 42 | ChiCTR2000039799 | 2019-07-01 | 2020-11-10 | Reduction or discontinuation of tofacitinib in patients with rheumatoid arthritis after low disease activity: a multicenter, prospective study | Reduction or discontinuation of tofacitinib in patients with rheumatoid arthritis after low disease activity: a multicenter, prospective study | Rheumatoid Arthritis | A:Keep the dose of tofacitinib unchanged;B:Reduce the dose of tofacitinib to 5mg qd;C:Stop using tofacitinib; | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 | 70 | Both | A:42;B:42;C:42; | Phase 4 | China |
| 43 | NCT03970837 (ClinicalTrials.gov) | June 5, 2019 | 16/5/2019 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs) | A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs | Arthritis, Rheumatoid | Biological: GSK3196165 (Otilimab);Drug: Tofacitinib;Drug: Placebo to GSK3196165 (Otilimab);Drug: Placebo to Tofacitinib;Drug: csDMARDs | GlaxoSmithKline | Iqvia Pty Ltd | Active, not recruiting | 18 Years | N/A | All | 1764 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;China;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Thailand;United Kingdom |
| 44 | EUCTR2018-004539-54-DE (EUCTR) | 03/06/2019 | 10/04/2019 | Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy | Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte | Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Trade Name: Enbrel Trade Name: Celebrex | Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 4 | Germany | ||
| 45 | NCT03980483 (ClinicalTrials.gov) | May 16, 2019 | 15/5/2019 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Arthritis, Rheumatoid;Glycogen Storage Disease Type II | Biological: GSK3196165 (Otilimab);Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acid | GlaxoSmithKline | Iqvia Pty Ltd | Active, not recruiting | 18 Years | N/A | All | 1537 | Phase 3 | United States;Argentina;Canada;China;Czechia;Hungary;India;Italy;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom |
| 46 | NCT03868072 (ClinicalTrials.gov) | February 22, 2019 | 6/3/2019 | Study to Evaluate the Bioequivalence of Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers | An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical Chong Kun Dang Tofacitinib Tablet and Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers | Rheumatoid Arthritis | Drug: XELJANZ 5Mg Tablet;Drug: Chong Kun Dang Tofacitinib Tablet | Chong Kun Dang Pharmaceutical | NULL | Completed | 19 Years | N/A | All | 40 | Phase 1 | Korea, Republic of |
| 47 | EUCTR2018-003162-13-IT (EUCTR) | 23/01/2019 | 08/11/2018 | A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib | A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128 | 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] - Immune System Diseases [C20] | Trade Name: XELJANZ 5 mg film-coated tablets Product Name: Xeljanz 5mg INN or Proposed INN: TOFACITINIB | AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Italy | ||
| 48 | NCT03981900 (ClinicalTrials.gov) | January 4, 2019 | 7/6/2019 | IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis | IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study. | Arthritis, Rheumatoid | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 500 | France | |
| 49 | NCT03755466 (ClinicalTrials.gov) | November 21, 2018 | 21/11/2018 | Examination of Efficacy and Safety of Baricitinib in RA Patients | Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib | Rheumatoid Arthritis | Drug: Baricitinib, olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz] | Shinshu University | NULL | Recruiting | 20 Years | N/A | All | 90 | Phase 2 | Japan |
| 50 | EUCTR2017-002753-11-FI (EUCTR) | 25/01/2018 | 08/11/2017 | The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritis | The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17 | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Xeljanz Product Name: Xeljanz Product Code: PRD4862257 Other descriptive name: TOFACITINIB CITRATE Trade Name: Tofacitinib Product Code: PRD4862257 | Tampere University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 4 | Finland | ||
| 51 | NCT03387423 (ClinicalTrials.gov) | November 2, 2017 | 7/12/2017 | Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis | ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS | Arthritis, Rheumatoid | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 1500 | Germany | |
| 52 | NCT03440892 (ClinicalTrials.gov) | November 1, 2017 | 14/2/2018 | Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients | Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin | Rheumatoid Arthritis | Drug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinib | Vastra Gotaland Region | NULL | Recruiting | 20 Years | N/A | All | 2500 | Sweden | |
| 53 | EUCTR2016-001825-15-IT (EUCTR) | 28/06/2017 | 16/02/2018 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT | 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] - Immune System Diseases [C20] | Product Name: Tofacitinb Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 580 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy | ||
| 54 | EUCTR2016-001825-15-DE (EUCTR) | 26/06/2017 | 01/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 55 | EUCTR2016-002337-30-HR (EUCTR) | 05/06/2017 | 12/09/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | 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 Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 56 | EUCTR2016-002337-30-DE (EUCTR) | 24/05/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | 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 Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 269 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 57 | EUCTR2016-001825-15-BE (EUCTR) | 08/05/2017 | 28/02/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 58 | EUCTR2016-002337-30-CZ (EUCTR) | 03/05/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | 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 Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 59 | EUCTR2016-001825-15-HU (EUCTR) | 01/05/2017 | 22/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 60 | EUCTR2016-001825-15-BG (EUCTR) | 11/04/2017 | 07/02/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 61 | EUCTR2016-002337-30-BG (EUCTR) | 11/04/2017 | 30/01/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | 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 Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 62 | EUCTR2016-002337-30-SK (EUCTR) | 10/04/2017 | 08/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis MedDRA version: 21.0;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 Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | ,NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 63 | EUCTR2016-001825-15-GB (EUCTR) | 03/04/2017 | 01/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 64 | EUCTR2016-001825-15-PL (EUCTR) | 29/03/2017 | 08/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3;Phase 4 | Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 65 | EUCTR2016-002337-30-ES (EUCTR) | 27/03/2017 | 10/03/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH 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 Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 66 | EUCTR2016-001825-15-CZ (EUCTR) | 21/03/2017 | 21/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 67 | EUCTR2016-002337-30-HU (EUCTR) | 16/03/2017 | 06/02/2017 | A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | 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 Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina | ||
| 68 | EUCTR2016-001825-15-ES (EUCTR) | 09/03/2017 | 10/03/2017 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | 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] - Immune System Diseases [C20] | Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 580 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 69 | EUCTR2016-001825-15-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis MedDRA version: 21.0;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: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 70 | NCT03016884 (ClinicalTrials.gov) | January 2017 | 1/1/2017 | Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients | Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation | Herpes Zoster | Biological: Zostavax vaccine | HaEmek Medical Center, Israel | NULL | Active, not recruiting | 50 Years | N/A | All | 87 | Phase 4 | Israel |
| 71 | NCT02996500 (ClinicalTrials.gov) | November 10, 2016 | 13/10/2016 | Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | Rheumatoid Arthritis | Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 269 | Phase 2 | United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine |
| 72 | NCT02831855 (ClinicalTrials.gov) | September 1, 2016 | 11/7/2016 | Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis | A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION | Rheumatoid Arthritis | Drug: CP-690,550;Drug: Methotrexate;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 694 | Phase 4 | United States;Australia;Belgium;Bulgaria;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Philippines;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom |
| 73 | NCT03011281 (ClinicalTrials.gov) | September 2016 | 30/12/2016 | Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis | Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tofacitinib | Hanyang University | NULL | Recruiting | 19 Years | N/A | All | 378 | Korea, Republic of | |
| 74 | JPRN-UMIN000027242 | 2016/08/31 | 03/05/2017 | the effect of tofacitinib on bone mineral density in patients with rheumatoid arthritis | to determine the effect of tofacitinib on bone | tofacitinib | Division of rheumatology, hiroshima clinic | Hatta clinicSky clinicToyohira hospital | Complete: follow-up continuing | 18years-old | 90years-old | Male and Female | 50 | Phase 4 | Japan | |
| 75 | EUCTR2015-002523-26-HU (EUCTR) | 08/03/2016 | 13/11/2015 | Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal) | Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal) | 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] - Immune System Diseases [C20] | Product Name: Tofacitinib Product Code: CP-690,55-10 | Arthritis Alapítvány | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Hungary | ||||
| 76 | NCT02321930 (ClinicalTrials.gov) | February 16, 2016 | 23/9/2014 | Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients | Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: tofacitinib 5mg po bid | University of California, Los Angeles | NULL | Completed | 18 Years | N/A | All | 37 | Phase 4 | United States |
| 77 | EUCTR2014-000358-13-DE (EUCTR) | 14/01/2016 | 31/07/2015 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Trade Name: Zostavax® Product Name: Zostavax | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 78 | JPRN-UMIN000027241 | 2015/08/31 | 03/05/2017 | the change of IMT of carotide artery in RA with treatment of tocilizumab | rheumatoid arthritis | tofacitinib | hiroshima clinic | NULL | Complete: follow-up complete | 18years-old | 80years-old | Male and Female | 50 | Not applicable | Japan | |
| 79 | EUCTR2013-003177-99-AT (EUCTR) | 17/08/2015 | 07/05/2015 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 80 | EUCTR2013-003177-99-FI (EUCTR) | 12/08/2015 | 12/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc., 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 81 | EUCTR2014-000358-13-HR (EUCTR) | 08/06/2015 | 10/11/2015 | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 82 | JPRN-UMIN000017440 | 2015/05/18 | 07/05/2015 | In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. | In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. - RAXEL study | Rheumatoid arthritis | for 3 months Tofacitinib 5mg BID everyday for 3 months Tofacitinib 5mg BID everyday for 3 months Methotrexate6mg-16mg/week | Graduate School of Medicine and School of Medicine, Chiba Universitythe department of allergy and clinical immunology | NULL | Complete: follow-up complete | 18years-old | 90years-old | Male and Female | 134 | Phase 4 | Japan |
| 83 | JPRN-UMIN000024143 | 2015/05/01 | 23/09/2016 | efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis | atherosclerosis efficacy of tofacitinib in RA | RA patients with moderate to severe active disease despite MTX treatment (disease activity score: DAS28>3.2) | hiroshima clinic | NULL | Complete: follow-up continuing | 18years-old | 75years-old | Male and Female | 50 | Phase 4 | Japan | |
| 84 | NCT02566967 (ClinicalTrials.gov) | May 2015 | 1/10/2015 | An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective | An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target | Rheumatoid Arthritis | Drug: tofacitinib | Norman B. Gaylis, MD | NULL | Completed | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 85 | EUCTR2014-000358-13-ES (EUCTR) | 13/01/2015 | 22/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;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: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 86 | JPRN-UMIN000020663 | 2014/12/16 | 21/01/2016 | A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. | Rheumatoid arthritis | Period :12 months Patients take Tofacitinib 5mg twice a day. | Kyusyu University Hospital Medicine and biosystemic science | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan | |
| 87 | EUCTR2014-000358-13-CZ (EUCTR) | 04/12/2014 | 04/08/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 88 | EUCTR2014-000358-13-PL (EUCTR) | 03/12/2014 | 24/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 89 | NCT02281552 (ClinicalTrials.gov) | November 18, 2014 | 30/10/2014 | A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate | Rheumatoid Arthritis | Drug: Tofacitinib | Pfizer | NULL | Completed | 20 Years | N/A | All | 209 | Phase 3 | Japan |
| 90 | EUCTR2014-000358-13-EE (EUCTR) | 13/11/2014 | 07/08/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;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: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 91 | EUCTR2014-000358-13-GB (EUCTR) | 12/11/2014 | 12/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 92 | EUCTR2014-000358-13-RO (EUCTR) | 10/11/2014 | 10/03/2015 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;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: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 93 | EUCTR2014-000358-13-BG (EUCTR) | 06/11/2014 | 28/10/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 94 | EUCTR2014-000706-34-GB (EUCTR) | 06/10/2014 | 18/07/2014 | A Study to Determine the Body's Immune Response To a Vaccination for Herpes Zoster In Subjects Who Have Rheumatoid Arthritis and Receive Tofacitinib (CP-690,550) (the drug being tested) or Placebo | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT | RHEUMATOID ARTHRITIS MedDRA version: 17.1;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: tofacitinib citrate Product Code: CP-690,550 – 10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;Hungary;Germany;United Kingdom | ||
| 95 | EUCTR2014-000358-13-LT (EUCTR) | 03/10/2014 | 11/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany | ||
| 96 | JPRN-UMIN000015462 | 2014/10/01 | 17/10/2014 | Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) | Rheumatoid arthritis | Continue current treatment Tofacitinib discontinuation MTX discontinuation | School of Medicine, University of Occupational and Environmental Health, Japan | NULL | Recruiting | 18years-old | Not applicable | Male and Female | 400 | Not selected | Japan | |
| 97 | EUCTR2014-000358-13-LV (EUCTR) | 26/09/2014 | 11/09/2014 | A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis | A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A | Moderately to severely active 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3;Phase 4 | Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 98 | EUCTR2011-005689-39-SK (EUCTR) | 24/09/2014 | 07/07/2014 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 2 | United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of | ||
| 99 | EUCTR2013-003177-99-NL (EUCTR) | 09/09/2014 | 25/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | 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] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 100 | EUCTR2011-005689-39-NL (EUCTR) | 01/09/2014 | 23/06/2014 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of | ||
| 101 | NCT02187055 (ClinicalTrials.gov) | August 2014 | 8/7/2014 | An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate | A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis | Rhematoid Arthritis | Drug: Tofacitinib with methotrexate;Drug: Tofacitinib without methotrexate;Biological: Adalimumab with methotrexate | Pfizer | NULL | Completed | 18 Years | N/A | All | 1152 | Phase 4 | United States;Argentina;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Czechia;Estonia;Israel;Korea, Republic of;Latvia;Lithuania;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Croatia;Czech Republic;France |
| 102 | EUCTR2013-003177-99-GB (EUCTR) | 17/07/2014 | 11/03/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS 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] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 103 | EUCTR2013-003177-99-CZ (EUCTR) | 10/07/2014 | 05/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS 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] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | Mexico;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 104 | NCT02147587 (ClinicalTrials.gov) | June 2014 | 22/5/2014 | A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment | Rheumatoid Arthritis | Drug: Tofacitinib;Drug: Placebo | Pfizer | NULL | Completed | 50 Years | N/A | All | 112 | Phase 2 | United States;United Kingdom |
| 105 | EUCTR2013-003177-99-ES (EUCTR) | 07/05/2014 | 17/03/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | 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] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 106 | EUCTR2013-003177-99-SK (EUCTR) | 28/04/2014 | 10/03/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS 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] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 107 | EUCTR2013-003177-99-SE (EUCTR) | 11/04/2014 | 05/02/2014 | A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis. | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 3;Phase 4 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 108 | NCT02092467 (ClinicalTrials.gov) | March 14, 2014 | 3/3/2014 | Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis | PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Arthritis, Rheumatoid | Drug: tofacitinib;Biological: adalimumab;Biological: etanercept | Pfizer | NULL | Completed | 50 Years | N/A | All | 4372 | Phase 4 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;Finland;Hong Kong;Israel;Jordan;Lebanon;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Sweden |
| 109 | EUCTR2011-005689-39-DE (EUCTR) | 20/01/2014 | 24/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 2 | United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of | ||
| 110 | EUCTR2011-005689-39-CZ (EUCTR) | 07/08/2013 | 23/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 111 | NCT01932372 (ClinicalTrials.gov) | July 26, 2013 | 30/7/2013 | Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis | XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE) | Rheumatoid Arthritis | Drug: Tofacitinib (Xeljanz);Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc | Pfizer | NULL | Completed | N/A | N/A | All | 9968 | Japan | |
| 112 | EUCTR2011-005689-39-HU (EUCTR) | 27/06/2013 | 22/05/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc, 235 East 42nd Street, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 113 | EUCTR2011-005689-39-ES (EUCTR) | 26/06/2013 | 24/06/2013 | A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis) | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | Ankylosing Spondylitis (AS) MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. 235 East 42nd Street, New York, 10017 | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 114 | NCT01741493 (ClinicalTrials.gov) | November 2012 | 3/12/2012 | A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494 | A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494 | Rheumatoid Arthritis | Drug: ABT-494;Drug: Placebo;Drug: Tofacitinib | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 75 Years | All | 67 | Phase 1 | United States |
| 115 | NCT01262118 (ClinicalTrials.gov) | May 2011 | 15/11/2010 | Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis | An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CP-690,550 (tasocitinib) | Pfizer | NULL | Completed | 18 Years | N/A | All | 69 | Phase 1 | United States;Hungary |
| 116 | EUCTR2010-020890-18-CZ (EUCTR) | 25/02/2011 | 02/11/2010 | AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS | AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: tasocitinib citrate Trade Name: Methotrexate Sodium Tablets 2.5 mg INN or Proposed INN: Methotrexate Sodium | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Czech Republic | ||
| 117 | EUCTR2010-020890-18-HU (EUCTR) | 18/02/2011 | 16/11/2010 | Tofacitinib MRI in Early Rheumatoid Arthritis | AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF Tofacitinib (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: tasocitinib citrate Trade Name: Methotrexate Sodium Tablets 2.5 mg INN or Proposed INN: Methotrexate Sodium | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Czech Republic;Hungary | ||
| 118 | EUCTR2006-005035-19-HU (EUCTR) | 01/10/2010 | 19/09/2007 | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CP-690,550 Product Code: CP-690,550 Product Name: CP-690,550 Product Code: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 2;Phase 3 | Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden | ||
| 119 | NCT01164579 (ClinicalTrials.gov) | October 2010 | 15/7/2010 | Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA) | An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tasocitinib plus Methotrexate;Drug: Tofacitinib plus placebo methotrexate;Drug: Placebo tofacitinib plus Methotrexate | Pfizer | NULL | Completed | 18 Years | N/A | All | 109 | Phase 2 | United States;Argentina;Chile;Croatia;Czech Republic;Hungary;Mexico;Poland;Puerto Rico |
| 120 | NCT01184001 (ClinicalTrials.gov) | September 2010 | 17/8/2010 | A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects | A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects | Rheumatoid Arthritis | Drug: Treatment A;Drug: Treatment B | Pfizer | NULL | Completed | 21 Years | 55 Years | Both | 16 | Phase 1 | Singapore |
| 121 | NCT01184092 (ClinicalTrials.gov) | August 2010 | 16/8/2010 | A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550) | Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions | Rheumatoid Arthritis | Drug: Treatment A;Drug: Treatment B;Drug: Treatment C | Pfizer | NULL | Completed | 21 Years | 55 Years | Both | 24 | Phase 1 | Singapore |
| 122 | EUCTR2009-016987-34-DE (EUCTR) | 03/05/2010 | 17/02/2010 | Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis | PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS | Moderate to severe active 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: Not applicable Product Code: CP-690,550 INN or Proposed INN: Tofacitinib Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM | Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Denmark;Australia;Peru;Korea, Republic of;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden | ||
| 123 | EUCTR2009-014296-40-AT (EUCTR) | 07/04/2010 | 29/12/2009 | PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS | PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS | Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: tasocitinib (proposed INN) Product Code: CP-690,550 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 124 | EUCTR2006-005035-19-IE (EUCTR) | 06/01/2010 | 07/10/2009 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | Rheumatoid arthritis MedDRA version: 17.1;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: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4500 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 125 | EUCTR2006-005035-19-FI (EUCTR) | 21/09/2009 | 15/06/2009 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | Rheumatoid arthritis MedDRA version: 17.1;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: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4500 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 126 | EUCTR2006-005035-19-GB (EUCTR) | 03/09/2009 | 27/04/2009 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | Rheumatoid arthritis MedDRA version: 17.1;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: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 127 | EUCTR2006-005035-19-DK (EUCTR) | 11/08/2009 | 23/06/2009 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | Rheumatoid arthritis MedDRA version: 17.1;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: Tofacitinib citrate( Phase III formulation) Product Code: CP-690,550-10 Product Name: Tofacitinib citrate (Proposed commercial formulation debossed) Product Code: CP-690,550-10 | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4500 | Phase 2;Phase 3 | Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 128 | EUCTR2006-005035-19-BG (EUCTR) | 04/08/2008 | 10/06/2009 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: NA Other descriptive name: NA Product Name: Tofacitinib citrate (Proposed commercial formulation- debossed) Product Code: CP-690,550-10 INN or Proposed INN: NA Other descriptive name: NA | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 129 | EUCTR2006-005035-19-DE (EUCTR) | 01/02/2008 | 04/10/2007 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 130 | EUCTR2006-005035-19-CZ (EUCTR) | 14/11/2007 | 20/09/2007 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citate (Phase III formulation) Product Code: CP-690,550-10 Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed) Product Code: CP-690,550-10 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4500 | Phase 2;Phase 3 | Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 131 | NCT03414502 (ClinicalTrials.gov) | August 2007 | 2/1/2014 | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Abatacept;Drug: Adalimumab;Drug: Azathioprine;Drug: Baricitinib;Drug: Certolizumab;Drug: Etanercept;Drug: Golimumab;Drug: Hydroxychloroquine;Drug: Infliximab;Drug: Leflunomide;Drug: Minocycline;Drug: Rituximab;Drug: Sarilumab;Drug: Sulfasalazine;Drug: Tofacitinib | University of Nebraska | NULL | Recruiting | 19 Years | N/A | All | 400 | Phase 3 | United States |
| 132 | EUCTR2006-005035-19-SK (EUCTR) | 10/07/2007 | 09/04/2008 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | 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] - Immune System Diseases [C20] | Product Name: CP-690,550 Product Code: CP-690,550-10 Product Name: CP-690,550 Product Code: CP-690,550-10 | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 133 | EUCTR2006-005035-19-SE (EUCTR) | 04/05/2007 | 16/03/2007 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | Rheumatoid arthritis MedDRA version: 17.1;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: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4500 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 134 | EUCTR2006-005035-19-BE (EUCTR) | 17/04/2007 | 09/01/2007 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | 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] - Immune System Diseases [C20] | Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4500 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 135 | EUCTR2006-005035-19-AT (EUCTR) | 15/02/2007 | 12/02/2007 | A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis | A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A | Rheumatoid arthritis MedDRA version: 17.1;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: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 2;Phase 3 | United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 136 | NCT00413699 (ClinicalTrials.gov) | February 5, 2007 | 18/12/2006 | Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis | A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: CP-690,550 | Pfizer | NULL | Completed | 18 Years | N/A | All | 4488 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Costa Rica;Croatia;Czechia;Denmark;Dominican Republic;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;United States Minor Outlying Islands |
| 137 | NCT01745055 (ClinicalTrials.gov) | April 2005 | 4/12/2012 | Co-Administration Of Methotrexate And CP-690,550 | A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects | Rheumatoid Arthritis | Drug: CP-690,550 (tofacitinib);Drug: Methotrexate (MTX) | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 12 | Phase 1 | United States |