Impact (DrugBank: -)
8 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 12 |
| 13 | 多発性硬化症／視神経脊髄炎 | 40 |
| 46 | 悪性関節リウマチ | 41 |
| 50 | 皮膚筋炎／多発性筋炎 | 1 |
| 53 | シェーグレン症候群 | 6 |
| 96 | クローン病 | 21 |
| 97 | 潰瘍性大腸炎 | 32 |
| 299 | 嚢胞性線維症 | 22 |
| 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 | NCT02954978 (ClinicalTrials.gov) | January 2017 | 1/11/2016 | Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | Parkinson Disease;Parkinsons Disease With Dementia | Drug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna] | Georgetown University | NULL | Active, not recruiting | 40 Years | 90 Years | All | 75 | Phase 2 | United States |
| 2 | NCT03192046 (ClinicalTrials.gov) | September 2016 | 13/6/2017 | Bracing for Walking in Parkinson's Disease | Impact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PD | Gait Disorders, Neurologic;Parkinson Disease | Device: Carbon Fiber Ankle Foot Orthosis (AFO) | University of Texas Southwestern Medical Center | American Orthotic and Prosthetic Association | Recruiting | 30 Years | 85 Years | All | 16 | N/A | United States |
| 3 | JPRN-jRCTs041180070 | 04/11/2015 | 07/03/2019 | Trerief Impact in PD PET Study | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS | Parkinson's disease Parkinson's disease;D010300 | [1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Ouchi Yasuomi | NULL | Not Recruiting | Not applicable | < 80age old | Both | 20 | N/A | Japan |
| 4 | JPRN-UMIN000019524 | 2015/10/01 | 28/10/2015 | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) | Parkinson's Disease | Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | Not applicable | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 5 | NCT01538329 (ClinicalTrials.gov) | March 2012 | 20/2/2012 | Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease | Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study) | Parkinson Disease | Drug: placebo;Drug: Amantadine | University Hospital, Toulouse | NULL | Recruiting | 35 Years | N/A | Both | 202 | Phase 2 | France |
| 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 |
| 6 | NCT01291537 (ClinicalTrials.gov) | November 2011 | 7/2/2011 | Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients | Parkinson's Disease | Drug: Duodopa;Drug: best médical treatment | Poitiers University Hospital | NULL | Completed | 18 Years | 80 Years | Both | 56 | Phase 2 | France | |
| 7 | NCT01545856 (ClinicalTrials.gov) | September 2011 | 2/2/2012 | Cardiovascular Events in Parkinson's Disease Patients | Background Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact Database | Cardiovascular Event;Parkinson Disease | Drug: levodopa | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 1 | N/A | NULL |
| 8 | EUCTR2010-022363-35-DE (EUCTR) | 18/02/2011 | 19/10/2010 | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Madopar LT Product Name: Levodopa / Benserazid Product Code: LD / BE INN or Proposed INN: LEVODOPA Other descriptive name: - INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE Other descriptive name: - Trade Name: Neupro Product Name: Rotigotin Product Code: RO INN or Proposed INN: ROTIGOTINE Other descriptive name: - | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 9 | NCT01785628 (ClinicalTrials.gov) | August 2010 | 24/6/2011 | The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's Disease | Parkinson's Disease With Dementia | Dietary Supplement: Sarcosine Capsule;Dietary Supplement: Placebo Capsule | China Medical University Hospital | National Science Council, Taiwan | Completed | N/A | N/A | All | 30 | N/A | Taiwan | |
| 10 | NCT00611481 (ClinicalTrials.gov) | October 2008 | 6/2/2008 | Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease | Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease | Parkinson's Disease | Behavioral: Tai Chi;Behavioral: Strength training;Behavioral: Low-Impact Exercise Control | Oregon Research Institute | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 40 Years | 85 Years | Both | 195 | Phase 2 | United States |
| 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 |
| 11 | NCT00465452 (ClinicalTrials.gov) | January 2007 | 24/4/2007 | Impact of Switching to Continuous Release Dopamine Agonists | The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects | Parkinson Disease | Drug: Continuous Release Dopamine Agonists | University of Toledo Health Science Campus | NULL | Completed | 55 Years | N/A | Both | 15 | Phase 3 | United States |
| 12 | NCT00141518 (ClinicalTrials.gov) | March 2006 | 30/8/2005 | Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact | A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia | Advanced Idiopathic Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube) | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 99 Years | All | 77 | Phase 4 | Norway;Sweden |
| 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 | NCT04466150 (ClinicalTrials.gov) | August 30, 2020 | 7/7/2020 | Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset | Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset | Relapsing Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | University of California, San Francisco | Genentech, Inc.;Valhalla Charitable Foundation | Recruiting | 18 Years | 50 Years | All | 30 | Phase 4 | United States |
| 2 | EUCTR2017-003008-30-GB (EUCTR) | 01/07/2020 | 17/05/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 | Multiple Sclerosis (Secondary Progressive) MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets Product Code: Not applicable INN or Proposed INN: Simvastatin | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | ||
| 3 | NCT03910738 (ClinicalTrials.gov) | October 29, 2019 | 1/4/2019 | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection;Drug: Placebo 4 mL Solution for Injection;Procedure: MRI;Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities;Behavioral: Assessment of disability | University Hospital, Strasbourg, France | Bayer;Fédération Hospitalo-Universitaire NEUROGENYCS | Recruiting | 18 Years | 55 Years | Male | 40 | Phase 2 | France |
| 4 | NCT03963375 (ClinicalTrials.gov) | October 28, 2019 | 23/5/2019 | Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis | Cladribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System Biomarkers in Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Cladribine | Washington University School of Medicine | EMD Serono | Recruiting | 18 Years | 65 Years | All | 50 | Phase 4 | United States |
| 5 | NCT04048577 (ClinicalTrials.gov) | July 3, 2019 | 15/4/2019 | A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of Natalizumab | The Impact of a Planned 12-week Dosing Interruption of Natalizumab on Immune Cell Trafficking, Pharmacokinetic (PK)/Pharmacodynamic (PD) Parameters, and Multiple Sclerosis (MS) Disease Stability. | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Dosing Interruption of Natalizumab | Berkovich, Regina MD, PhD Inc. | Biogen;Cedars-Sinai Medical Center | Recruiting | 21 Years | 65 Years | All | 10 | Phase 4 | United States |
| 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 |
| 6 | NCT03896217 (ClinicalTrials.gov) | May 16, 2019 | 26/10/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A Double-blind, Randomised, Placebo-controlled Single-site Study of High Dose Simvastatin Treatment for Secondary Progressive Multiple Sclerosis: Impact on Vascular Perfusion and Oxidative Damage | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin | University College, London | MS Society | Recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | United Kingdom |
| 7 | NCT03740295 (ClinicalTrials.gov) | October 5, 2018 | 5/10/2018 | Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis | Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Coconut oil and epigallocatechin gallate;Other: Placebo | Fundación Universidad Católica de Valencia San Vicente Mártir | Valencian Institute of Neurorehabilitation Foundation | Completed | 19 Years | 65 Years | All | 60 | Phase 2 | Spain |
| 8 | NCT03589105 (ClinicalTrials.gov) | August 6, 2018 | 5/7/2018 | A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting | An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mg | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 423 | Phase 4 | France |
| 9 | NCT03385356 (ClinicalTrials.gov) | December 19, 2017 | 20/12/2017 | Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis | Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Vitamin D Deficiency | Drug: Vitamin D | University Medical Centre Maribor | Medical Faculty Maribor | Completed | 18 Years | 60 Years | All | 89 | Phase 4 | Slovenia |
| 10 | EUCTR2017-004846-31-SI (EUCTR) | 14/12/2017 | 05/12/2017 | Vitamin D supplementation in patients with multiple sclerosis | Impact of vitamin D supplementation in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: LLT;Classification code 10064137;Term: Progression of multiple sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Oleovit D3 14.400 IU/ml oral drops, solution | University medical centre Maribor | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 4 | Slovenia | ||
| 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 |
| 11 | NCT03418376 (ClinicalTrials.gov) | February 1, 2017 | 9/1/2018 | Carnosine Loading and Periodized Training in MS and HC | The Impact of Carnosine Loading and Rehabilitation Therapy on Exercise Capacity in Multiple Sclerosis. | Multiple Sclerosis;Exercise Therapy;Dietary Supplement | Dietary Supplement: Beta-alanine supplementation;Other: Exercise intervention | Hasselt University | NULL | Completed | 18 Years | 75 Years | All | 45 | N/A | Belgium |
| 12 | NCT02652091 (ClinicalTrials.gov) | February 5, 2016 | 5/1/2016 | Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction | Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaseron, BAY86-5046);Device: BETACONNECT device | Bayer | NULL | Completed | 18 Years | N/A | All | 146 | United States | |
| 13 | NCT02323269 (ClinicalTrials.gov) | May 2015 | 18/12/2014 | Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve) | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve) | Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | N/A | Both | 24 | N/A | Canada |
| 14 | NCT02736279 (ClinicalTrials.gov) | May 2015 | 22/3/2016 | Impact of Tecfidera on Gut Microbiota | Measuring the Impact of Tecfidera on the Gut Microbiota: Does a Change in the Gut Flora Correlate With Gastrointestinal Disturbances Following Therapy Initiation? | Multiple Sclerosis | Drug: Dimethyl fumarate | Virginia Simnad | Biogen | Recruiting | 18 Years | N/A | Both | 25 | N/A | United States |
| 15 | EUCTR2013-004622-29-DE (EUCTR) | 23/02/2015 | 11/11/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 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 |
| 16 | EUCTR2013-004622-29-DK (EUCTR) | 29/01/2015 | 04/12/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 17 | EUCTR2013-004622-29-SE (EUCTR) | 30/12/2014 | 29/09/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 18 | EUCTR2013-004622-29-ES (EUCTR) | 03/12/2014 | 03/10/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 19 | NCT02342704 (ClinicalTrials.gov) | November 30, 2014 | 15/1/2015 | Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Relapsing-Remitting Multiple Sclerosis | Drug: natalizumab;Drug: fingolimod | Biogen | NULL | Terminated | 18 Years | 60 Years | All | 111 | Phase 4 | United States;Australia;Czechia;France;Germany;Italy;Spain;Sweden;United Kingdom;Czech Republic;Denmark |
| 20 | EUCTR2013-004622-29-GB (EUCTR) | 20/11/2014 | 28/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 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 |
| 21 | EUCTR2013-004622-29-IT (EUCTR) | 10/11/2014 | 05/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden | |||
| 22 | NCT02326935 (ClinicalTrials.gov) | November 2014 | 18/12/2014 | Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis | Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis | Multiple Sclerosis | Biological: Autologous adipose derived mesenchymal cells | American CryoStem Corporation | NULL | Terminated | 18 Years | 65 Years | All | 2 | Phase 1 | Cayman Islands |
| 23 | EUCTR2013-004622-29-CZ (EUCTR) | 31/10/2014 | 13/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 24 | NCT01903291 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS | A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 333 | N/A | United States |
| 25 | NCT01791244 (ClinicalTrials.gov) | February 28, 2013 | 12/2/2013 | A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device | A Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart Device | Multiple Sclerosis;Relapsing-Remitting | Drug: Rebif® | Merck KGaA | NULL | Completed | 18 Years | N/A | All | 93 | Phase 4 | Germany;Sweden |
| 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 |
| 26 | NCT01601119 (ClinicalTrials.gov) | January 2012 | 15/5/2012 | Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients | The Impact of Disease Modifying Therapies (DMTs) and Associated Support Services on Patient Reported Experience Measures (PREMs) and Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients | Relapsing Multiple Sclerosis | Drug: Rebif;Other: Other: Disease modifying therapies (DMT) | Merck KGaA | Merck Serono Limited, UK | Completed | 18 Years | N/A | Both | 545 | N/A | United Kingdom |
| 27 | NCT01453868 (ClinicalTrials.gov) | October 2011 | 13/10/2011 | The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis | The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Other: Non Impact Aerobics;Other: Passive : lecture series | Nelson Mandela Metropolitan University | NULL | Recruiting | 20 Years | 60 Years | Both | 60 | Phase 0 | United States |
| 28 | NCT01407211 (ClinicalTrials.gov) | April 2011 | 14/2/2011 | Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient | The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: vitamin A | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 30 | Phase 4 | Iran, Islamic Republic of |
| 29 | NCT01705457 (ClinicalTrials.gov) | February 2010 | 9/10/2012 | Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis | Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients | Relapsing Remitting Multiple Sclerosis | Drug: Dietary Supplement: vitamin A;Drug: placebo | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 20 | Phase 4 | Iran, Islamic Republic of |
| 30 | NCT01417273 (ClinicalTrials.gov) | February 2010 | 17/11/2010 | Impact of Vitamin A on Multiple Sclerosis (MS) | Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: vitamin A;Drug: Drug: placebo | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 100 | Phase 4 | Iran, Islamic Republic of |
| 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 |
| 31 | NCT01065727 (ClinicalTrials.gov) | February 2010 | 8/2/2010 | Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis | Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis | Multiple Sclerosis | Other: mitoxantrone - immunomodulator;Other: natalizumab | Rennes University Hospital | NULL | Recruiting | 18 Years | N/A | Both | 250 | N/A | France |
| 32 | NCT01225289 (ClinicalTrials.gov) | October 2009 | 6/9/2010 | Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients | The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: Vitamin A;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 20 Years | 45 Years | All | 36 | Phase 4 | Iran, Islamic Republic of |
| 33 | NCT00981084 (ClinicalTrials.gov) | September 2009 | 18/9/2009 | Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS) | The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study | Multiple Sclerosis | Drug: armodafinil | University of Missouri, Kansas City | University of Kansas | Completed | 18 Years | 60 Years | All | 33 | Phase 2;Phase 3 | United States |
| 34 | NCT00787657 (ClinicalTrials.gov) | June 2008 | 6/11/2008 | Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment | Betaferon Prospective Study on Adherence, Coping and Nursing Support | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | N/A | Both | 1723 | N/A | Argentina;Bahrain;Belgium;Bosnia and Herzegovina;Canada;China;Colombia;Czech Republic;Egypt;Estonia;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Kuwait;Lebanon;Libyan Arab Jamahiriya;Mexico;Netherlands;New Zealand;Norway;Pakistan;Portugal;Saudi Arabia;Singapore;Slovakia;Slovenia;Sweden;Syrian Arab Republic;Taiwan;United Arab Emirates;United Kingdom;Venezuela |
| 35 | NCT00928967 (ClinicalTrials.gov) | May 2007 | 23/6/2009 | Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients | Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS | Multiple Sclerosis | Drug: Interferon beta-1b, (Betaseron BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 67 | N/A | France |
| 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 |
| 36 | NCT00594087 (ClinicalTrials.gov) | December 2006 | 3/1/2008 | Eszopiclone for Improving Sleep in Multiple Sclerosis (MS) | Eszopiclone for Improving Sleep Continuity in MS Patients With Sleep Disturbances and Its Impact on Daytime Fatigue | Relapsing Remitting Multiple Sclerosis;Sleep Initiation and Maintenance Disorders;Fatigue | Drug: eszopiclone;Other: placebo | University of Vermont | NULL | Completed | 18 Years | 64 Years | Both | 30 | N/A | United States |
| 37 | EUCTR2005-003410-15-SE (EUCTR) | 21/11/2005 | 29/09/2005 | A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MS | A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MS | Multiple sclerosis is a devastating inflammation in the central nervous system and it can often give cognitive dysfunction, affecting memory, mental concentration. Lately it has been shown that the cognitive dysfunction has a big impact on life quality. Immunomodulatory medication can only partially limit the bouts but there is no effective cure at the moment. There is little options to treat the effects on higher functions for the moment. | Trade Name: Aricept 5 mg filmdragerade tabletter Product Name: Aricept 5 mg INN or Proposed INN: Donepezil Trade Name: Aricept 10 mg filmdragerade tabletter Product Name: Aricept 10 mg INN or Proposed INN: Donepezil | Neurology Unit | NULL | Not Recruiting | Female: yes Male: yes | 20 | Sweden | |||
| 38 | NCT00239993 (ClinicalTrials.gov) | August 2005 | 22/9/2005 | A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone® | An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®. | Multiple Sclerosis | Drug: glatiramer acetate;Procedure: Warm compress prior to injection of glatiramer acetate | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | 55 Years | All | 50 | Phase 4 | United States |
| 39 | NCT00240032 (ClinicalTrials.gov) | October 2004 | 13/10/2005 | A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®. | A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe. | Multiple Sclerosis | Drug: glatiramer acetate injection with oral cetirizine hydrochloride;Drug: glatiramer acetate with placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | Both | 80 | Phase 4 | United States |
| 40 | NCT00220922 (ClinicalTrials.gov) | August 2004 | 20/9/2005 | A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®. | An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® | Multiple Sclerosis | Procedure: Alcohol Wipes vs. No Alcohol Wipes | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 4 | United States |
| 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 | NCT04117165 (ClinicalTrials.gov) | March 1, 2021 | 30/9/2019 | Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis | Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA) | Arthritis, Rheumatoid;Biological Therapy | Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care | University Hospital, Grenoble | NULL | Not yet recruiting | 18 Years | 70 Years | All | 180 | N/A | France |
| 2 | ChiCTR2000034924 | 2020-10-30 | 2020-07-24 | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Rheumatoid arthritis, Sjogren's syndrome | Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets; | The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | NULL | Pending | Both | Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler | Phase 1 | China | ||
| 3 | NCT04347798 (ClinicalTrials.gov) | September 2020 | 13/4/2020 | IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT | IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT | Covid-19 Infection;Rheumatoid Arthritis;Psoriatic Arthritis;Hydroxychloroquine | Other: Hydroxychloroquine/Chloroquine | University of Alberta | NULL | Enrolling by invitation | 18 Years | N/A | All | 500 | Canada | |
| 4 | NCT04428424 (ClinicalTrials.gov) | July 5, 2020 | 10/6/2020 | Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients | The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept | Arthritis, Rheumatoid | Drug: Enbrel | Pfizer | NULL | Completed | 18 Years | N/A | All | 1 | Iraq | |
| 5 | NCT04269993 (ClinicalTrials.gov) | June 1, 2020 | 12/2/2020 | Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis | Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Cannabis: placebo and medium THC/medium CBD | Brown University | NULL | Not yet recruiting | 18 Years | 65 Years | All | 76 | Phase 2 | NULL |
| 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 |
| 6 | 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 | |
| 7 | JPRN-UMIN000033059 | 2018/06/20 | 20/06/2018 | The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial | The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial - The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial | Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture | A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty | Hokusuikai Kinen Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 120 | Not selected | Japan |
| 8 | NCT03550833 (ClinicalTrials.gov) | June 13, 2018 | 28/5/2018 | Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model | Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model | Arthritis, Rheumatoid;Stress Disorder | Behavioral: Questionnaire;Biological: blood sample | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | All | 152 | France | |
| 9 | NCT01694693 (ClinicalTrials.gov) | January 31, 2018 | 24/9/2012 | Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study | Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study | Rheumatoid Arthritis | Drug: Orencia | Bristol-Myers Squibb | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | NULL |
| 10 | JPRN-UMIN000024025 | 2016/10/01 | 01/10/2016 | The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study | The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study - ALIBABA study | Rheumatoid Arthritis | receiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week) receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week) | Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 80 | Not applicable | Japan |
| 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 |
| 11 | NCT02037737 (ClinicalTrials.gov) | September 30, 2016 | 21/11/2013 | Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting | Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 153 | NULL | |
| 12 | NCT03762824 (ClinicalTrials.gov) | June 14, 2016 | 3/12/2018 | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response. | Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis | Biological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine | Region Skane | NULL | Active, not recruiting | 18 Years | N/A | All | 300 | Phase 4 | NULL |
| 13 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 14 | JPRN-UMIN000018931 | 2016/01/17 | 07/09/2015 | Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial | Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis | 1000 mg of intravenous acetaminophen (100 ml) after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery. 100ml of intravenous normal saline after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery. | Nekoyama Miyao Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan | |
| 15 | NCT02742597 (ClinicalTrials.gov) | January 12, 2016 | 21/3/2016 | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity | Behavioral: TIP / IMPACT Plus Care Coordination | Lawson Health Research Institute | Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital | Active, not recruiting | 18 Years | 80 Years | All | 1980 | N/A | Canada |
| 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 |
| 16 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit | INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| 17 | EUCTR2014-001114-26-SE (EUCTR) | 18/02/2015 | 26/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 18 | EUCTR2014-001114-26-NL (EUCTR) | 13/02/2015 | 24/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden | ||
| 19 | NCT02198651 (ClinicalTrials.gov) | January 5, 2015 | 22/7/2014 | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA) | Rheumatoid Arthritis;Musculoskeletal and Connective Tissue Diseases | Biological: Adalimumab;Other: Placebo | AbbVie | NULL | Completed | 18 Years | N/A | All | 149 | Phase 4 | United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 20 | EUCTR2014-001114-26-GR (EUCTR) | 12/12/2014 | 02/12/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 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 |
| 21 | EUCTR2014-001114-26-IE (EUCTR) | 11/12/2014 | 14/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 22 | EUCTR2014-001114-26-GB (EUCTR) | 25/11/2014 | 14/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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] | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | |||
| 23 | EUCTR2014-001114-26-ES (EUCTR) | 17/11/2014 | 01/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 24 | EUCTR2014-001114-26-FR (EUCTR) | 13/11/2014 | 18/06/2015 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 25 | EUCTR2014-001114-26-DE (EUCTR) | 10/11/2014 | 08/08/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 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 |
| 26 | EUCTR2014-001114-26-AT (EUCTR) | 05/11/2014 | 10/10/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 27 | EUCTR2014-001114-26-HU (EUCTR) | 04/11/2014 | 10/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 28 | EUCTR2014-001114-26-IT (EUCTR) | 20/10/2014 | 16/09/2014 | A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring | A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA) | 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: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 334 | Phase 4 | Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 29 | JPRN-UMIN000012257 | 2013/11/12 | 11/11/2013 | Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial | osteoarthritis, rheumatoid arthritis, avascular necrosis of femoral condyle | A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty | Nekoyama Miyao Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 74 | Not selected | Japan | |
| 30 | NCT01855789 (ClinicalTrials.gov) | November 2013 | 14/5/2013 | A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Tocilizumab;Drug: methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 718 | Phase 3 | United States | |
| 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 |
| 31 | NCT01557374 (ClinicalTrials.gov) | April 2012 | 16/3/2012 | TOward the Lowest Effective DOse of Abatacept or Tocilizumab | Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy | Rheumatoid Arthritis | Drug: Tocilizumab, Abatacept;Drug: Decrease Tocilizumab, Abatacept | Assistance Publique - Hôpitaux de Paris | Ministry of Health, France | Active, not recruiting | 18 Years | N/A | All | 232 | Phase 4 | France |
| 32 | NCT01438892 (ClinicalTrials.gov) | February 2012 | 20/9/2011 | Impact Of RA Therapy Compliance On Patient-Reported Outcomes | Impact Of RA Therapy Compliance On Patient-Reported Outcomes | Rheumatoid Arthritis | Drug: tDMARDs;Drug: biodmards | Pfizer | NULL | Completed | 18 Years | N/A | Both | 396 | N/A | United States |
| 33 | NCT01954381 (ClinicalTrials.gov) | October 2011 | 13/10/2011 | Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis | Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Device: transthoracic echocardiographic;Device: Doppler ultrasound.;Biological: blood samples | Assistance Publique Hopitaux De Marseille | NULL | Completed | 18 Years | N/A | Both | 60 | Phase 3 | France |
| 34 | NCT01462162 (ClinicalTrials.gov) | September 2011 | 27/10/2011 | A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis | A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 122 | N/A | Spain |
| 35 | NCT01333878 (ClinicalTrials.gov) | March 2011 | 7/4/2011 | Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage | An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray | Rheumatoid Arthritis | Biological: Subcutaneous Abatacept | Orrin M Troum, M.D. and Medical Associates | Bristol-Myers Squibb | Completed | 18 Years | N/A | Both | 12 | Phase 2;Phase 3 | United States |
| 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 |
| 36 | NCT01060098 (ClinicalTrials.gov) | April 2010 | 29/1/2010 | T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade | T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: anti-TNF therapy (etanercept or adalimumab) | Imperial College London | NULL | Completed | 18 Years | 80 Years | All | 48 | United Kingdom | |
| 37 | NCT00768053 (ClinicalTrials.gov) | October 2008 | 3/10/2008 | Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients | Open-Label Study To Evaluate The EULAR-RAID Score, Rheumatoid Arthritis Impact Of Disease Score, In Rheumatoid Arthritis Patients Eligible To Etanercept And Who Will Receive Etanercept | Rheumatoid Arthritis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | Lincoln Medical and Mental Health Center;Umanis;SODIA;depolabo | Completed | 18 Years | N/A | All | 108 | Phase 4 | France;Monaco |
| 38 | EUCTR2007-007888-24-FR (EUCTR) | 31/07/2008 | 17/07/2008 | Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW | Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW | RHEUMATOID ARTHRITIS | Trade Name: ENBREL INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 107 | France | |||
| 39 | EUCTR2007-006539-29-SE (EUCTR) | 14/03/2008 | 20/12/2007 | Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using Prevenar | Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using Prevenar | Patients with rheumatic diseases (rheumatoid arthritis and spondyloarthripaties) who are going to be vaccinated with Prevenar vaccine in order to study the serological responses to two pneumococcal serotypes and to study the impact of different treatment modalities on serological responses. | Trade Name: Prevenar vaccine Product Name: Prevenar vaccine INN or Proposed INN: 7-valent Pneumococcal Conjugate vaccine | Dept of Rheumatology, Lund University Hospital, Lund, Sweden | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Sweden | |||
| 40 | NCT00425932 (ClinicalTrials.gov) | February 2007 | 22/1/2007 | Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis | Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Rituximab | Gaylis, Norman B., M.D. | Oklahoma Medical Research Foundation;Genentech, Inc. | Completed | 18 Years | 80 Years | Both | 60 | Phase 2 | United States |
| 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 |
| 41 | NCT00378261 (ClinicalTrials.gov) | January 2004 | 15/9/2006 | APART Advanced Profiling of Anti-Rheumatic Therapies | A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis | Arthritis, Rheumatoid | Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects. | Centocor Ortho Biotech Services, L.L.C. | NULL | Completed | 18 Years | N/A | Both | 1079 | Phase 4 | NULL |
| 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 | ChiCTR-TRC-13003178 | 2013-05-01 | 2013-01-03 | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Polymyositis/Dermatomyositis | group1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d, maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group1-predinsone+MTX group:MTX 10-20mgQw×24w; MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.;group1-predinsone+LEF group:LEF 20mg/d×24w; LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.;group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w; CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.;group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w; MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.; | Department of rheumatology, China-Japan Friendship hospital | NULL | Recruiting | 18 | 70 | Both | group1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94; | China |
| 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 | ChiCTR2000034924 | 2020-10-30 | 2020-07-24 | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Rheumatoid arthritis, Sjogren's syndrome | Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets; | The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | NULL | Pending | Both | Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler | Phase 1 | China | ||
| 2 | NCT03983408 (ClinicalTrials.gov) | June 17, 2019 | 10/6/2019 | Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease | Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease | Sjögren's Syndrome;Rheumatic Diseases;Korean Red Ginseng | Dietary Supplement: Korean Red Ginseng;Dietary Supplement: Placebo | Hanyang University | The Korean Society of Ginseng | Recruiting | 19 Years | 75 Years | All | 120 | N/A | Korea, Republic of |
| 3 | NCT03762824 (ClinicalTrials.gov) | June 14, 2016 | 3/12/2018 | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response. | Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis | Biological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine | Region Skane | NULL | Active, not recruiting | 18 Years | N/A | All | 300 | Phase 4 | NULL |
| 4 | JPRN-UMIN000019009 | 2015/08/19 | 14/09/2015 | The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome | The dry eye patients complicated with Sjogren's syndrome | Mucosta ophthalmic suspensionUD2%, q.i.d. and Soft Santear, t.d. for 4weeks in both eyes Soft Santear, q.i.d. for 4weeks | Kyoto Prefectural University of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 5 | JPRN-UMIN000010796 | 2013/06/01 | 24/05/2013 | Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers | Sjogren's syndrome | single oral administration of pilocarpine. salagen (KISSEI PHARMACEUTICAL CO.,LTD.) 5mg 1Tablet. | Oita University Faculty of Medicine | NULL | Pending | 20years-old | Not applicable | Male and Female | 30 | Not applicable | Japan | |
| 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 |
| 6 | NCT01369589 (ClinicalTrials.gov) | November 2010 | 6/6/2011 | An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness | An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome | Xerostomia;Sjogren's Syndrome | Drug: P-552;Drug: Placebo | Parion Sciences | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1;Phase 2 | United States |
| 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 | NCT04223518 (ClinicalTrials.gov) | September 20, 2020 | 6/1/2020 | Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD) | Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Dietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: Placebo | Monisha Hitesh Shah | NULL | Recruiting | 6 Years | 30 Years | All | 43 | Early Phase 1 | United States |
| 2 | NCT04273399 (ClinicalTrials.gov) | March 2020 | 8/1/2020 | High-impact Exercise in Adults With Crohn's Disease | Feasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's Disease | Crohn Disease | Other: High-impact exercise intervention;Other: Acute response to high-impact exercise | NHS Greater Glasgow and Clyde | University of Glasgow | Not yet recruiting | 18 Years | 40 Years | All | 30 | N/A | United Kingdom |
| 3 | NCT04305535 (ClinicalTrials.gov) | February 13, 2020 | 5/3/2020 | Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease | Clinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN Disease | Crohn Disease;Absorption; Disorder, Protein; Disorder; Disorder, Fat; Disorder, Carbohydrate;Malnutrition | Dietary Supplement: Peptidic+Probiotic;Dietary Supplement: Peptidic+Placebo;Dietary Supplement: Polymeric+Placebo | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Adventia Pharma, S.L.;Biopolis S.L. | Recruiting | 18 Years | N/A | All | 162 | N/A | Spain |
| 4 | NCT03941418 (ClinicalTrials.gov) | June 1, 2019 | 5/5/2019 | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Ulcerative Colitis;Crohn Disease | Dietary Supplement: Boulardii;Dietary Supplement: Placebo | University Clinic Dr Dragisa Misovic-Dedinje | University Clinic Zvezdara | Not yet recruiting | 18 Years | 80 Years | All | 150 | N/A | NULL |
| 5 | NCT03012542 (ClinicalTrials.gov) | January 2017 | 4/1/2017 | Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease | Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome | Crohn Disease | Dietary Supplement: Diet 1;Dietary Supplement: Diet 2 | University of Washington | NULL | Unknown status | 18 Years | N/A | All | 32 | N/A | United States |
| 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 |
| 6 | NCT02704624 (ClinicalTrials.gov) | December 2016 | 24/2/2016 | Effects of Supplementation of Vitamin D in Patients With Crohn's Disease | The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial | Crohn Disease;Vitamin D Deficiency;Fatigue;Sarcopenia;Muscle Weakness;Disorder of Bone Density and Structure, Unspecified | Dietary Supplement: Vitamin D;Other: Placebo | Federal University of Juiz de Fora | Fundação de Amparo à Pesquisa do estado de Minas Gerais | Enrolling by invitation | 18 Years | 50 Years | All | 110 | Phase 4 | Brazil |
| 7 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 8 | NCT02742597 (ClinicalTrials.gov) | January 12, 2016 | 21/3/2016 | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity | Behavioral: TIP / IMPACT Plus Care Coordination | Lawson Health Research Institute | Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital | Active, not recruiting | 18 Years | 80 Years | All | 1980 | N/A | Canada |
| 9 | NCT02575040 (ClinicalTrials.gov) | May 2015 | 6/10/2015 | Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease | Ulcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction) | Biological: Fecal microbiota transplantation | Gulhane Military Medical Academy | NULL | Recruiting | 18 Years | N/A | Both | 60 | Phase 3 | Turkey |
| 10 | NCT02453607 (ClinicalTrials.gov) | November 17, 2014 | 21/5/2015 | The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease | The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease | Inflammatory Bowel Disease;Crohn's Disease | Drug: Infliximab;Drug: thiopurine | Ernest Seidman | University of Toronto;University of Calgary;University of Alberta | Recruiting | 18 Years | 70 Years | All | 225 | N/A | Canada |
| 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 |
| 11 | NCT02426567 (ClinicalTrials.gov) | November 2014 | 17/4/2015 | The Impact of Crohn's Disease-TReatment-with-EATing Diet and Exclusive Enteral Nutrition on Healthy Gut Bacteria | An Exploratory Study on the Impact of a Food-based Restrictive Diet (Crohn's Disease-TReatment-with EATing/CD-TREAT Diet) and Liquid Exclusive Enteral Nutrition (EEN) on Healthy Gut Microbiota Composition and Metabolic Activity | Crohn's Disease;Dietary Modification | Other: Exclusive Enteral Nutrition (EEN);Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet) | University of Glasgow | NULL | Completed | 18 Years | N/A | Both | 28 | N/A | United Kingdom |
| 12 | NCT02615288 (ClinicalTrials.gov) | January 2014 | 23/11/2015 | High Dose Vitamin D3 in Crohn's Disease | Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study | Crohn's Disease | Dietary Supplement: Vitamin D3 | McMaster University | Canadian Association of Gastroenterology | Completed | 18 Years | 70 Years | Both | 40 | N/A | NULL |
| 13 | NCT01864616 (ClinicalTrials.gov) | July 2013 | 22/5/2013 | The Impact of Vitamin D on Disease Activity in Crohn's Disease | Crohn Disease | Dietary Supplement: Vitamin D3 | University of Saskatchewan | Dania Alrefai;Dr.Jennifer Jones;Dr.Hani Jawa;Dr.Wael El-matary;Saudi Arabian Cultural Bureau | Terminated | 16 Years | 70 Years | All | 9 | N/A | Canada;Saudi Arabia | |
| 14 | NCT01847170 (ClinicalTrials.gov) | May 2013 | 2/5/2013 | Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease | Crohn's Disease | Biological: Fecal Microbial Transplantation | Beth Israel Deaconess Medical Center | The Broad Foundation;Brigham and Women's Hospital | Completed | 18 Years | N/A | All | 22 | Phase 1 | United States | |
| 15 | NCT02233062 (ClinicalTrials.gov) | May 2013 | 1/9/2014 | Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease | Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease | Crohn's Disease | Dietary Supplement: Exclusive Enteral Nutrition Therapy | Jinling Hospital, China | NULL | Completed | 18 Years | 40 Years | Male | 12 | N/A | China |
| 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 |
| 16 | NCT01218360 (ClinicalTrials.gov) | November 2011 | 7/10/2010 | Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484) | Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484) | Crohn Disease | Drug: Physician standard-of-care | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 65 Years | Both | 71 | N/A | Greece |
| 17 | NCT01540942 (ClinicalTrials.gov) | November 2011 | 23/2/2012 | Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease | A Randomized, Controlled, Open-label Study to Investigate the Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease | Crohn's Disease | Dietary Supplement: nutrition treat;Other: surgery | Jinling Hospital, China | NULL | Completed | 18 Years | 75 Years | Both | 91 | N/A | China |
| 18 | NCT02619552 (ClinicalTrials.gov) | August 2011 | 28/10/2015 | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Crohn's Disease;IBD | Drug: Anti-TNF;Drug: Steroids | University of Maryland, Baltimore | Vanderbilt University;Milton S. Hershey Medical Center;Mercy Medical Center | Completed | 18 Years | N/A | All | 50 | United States | |
| 19 | NCT01487759 (ClinicalTrials.gov) | March 2008 | 6/12/2011 | Prebiotic Effect on Metabolites in Crohn's Disease | Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients | Crohn Disease | Dietary Supplement: Oligofructose enriched inulin;Dietary Supplement: Maltodextrin | Katholieke Universiteit Leuven | NULL | Completed | 18 Years | N/A | Both | 67 | N/A | Belgium |
| 20 | NCT00621257 (ClinicalTrials.gov) | January 2008 | 11/2/2008 | Vitamin D Levels in Children With IBD | Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Dietary Supplement: ergocalciferol;Dietary Supplement: Cholecalciferol | Boston Children’s Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Crohn's and Colitis Foundation;NASPGHAN Foundation | Terminated | 5 Years | 21 Years | All | 134 | N/A | United States |
| 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 |
| 21 | NCT00705471 (ClinicalTrials.gov) | April 2005 | 23/6/2008 | Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED) | Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources | Crohn Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Terminated | 18 Years | N/A | Both | 42 | N/A | NULL |
| 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 | NCT04064697 (ClinicalTrials.gov) | December 2020 | 20/8/2019 | Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy | Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy. CYTOVEDO Study | Ulcerative Colitis, Unspecified | Drug: Valganciclovir | Centre Hospitalier Universitaire de Saint Etienne | Ministry of Health, France | Not yet recruiting | 18 Years | N/A | All | 120 | Phase 3 | France |
| 2 | EUCTR2020-004391-18-FR (EUCTR) | 28/10/2020 | 14/09/2020 | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Trade Name: AMGEVITA Product Name: AMGEVITA Trade Name: Simponi Product Name: Simponi Trade Name: Entyvio 300 mg Product Name: Entyvio 300 mg Trade Name: XELJANZ Product Name: XELJANZ | CHU Amiens-Picardie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | France | ||
| 3 | NCT04223518 (ClinicalTrials.gov) | September 20, 2020 | 6/1/2020 | Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD) | Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Dietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: Placebo | Monisha Hitesh Shah | NULL | Recruiting | 6 Years | 30 Years | All | 43 | Early Phase 1 | United States |
| 4 | EUCTR2019-001032-54-FR (EUCTR) | 23/07/2019 | 19/06/2019 | Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy | Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy - CYTOVEDO | Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058881;Term: Cytomegalovirus viremia;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | CHU de Saint Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | France | |||
| 5 | NCT03483246 (ClinicalTrials.gov) | June 18, 2019 | 26/2/2018 | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial | Ulcerative Colitis | Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation Placebo | Assistance Publique - Hôpitaux de Paris | CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France | Recruiting | 18 Years | 75 Years | All | 150 | Phase 3 | France |
| 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 |
| 6 | NCT03941418 (ClinicalTrials.gov) | June 1, 2019 | 5/5/2019 | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Ulcerative Colitis;Crohn Disease | Dietary Supplement: Boulardii;Dietary Supplement: Placebo | University Clinic Dr Dragisa Misovic-Dedinje | University Clinic Zvezdara | Not yet recruiting | 18 Years | 80 Years | All | 150 | N/A | NULL |
| 7 | NCT03504930 (ClinicalTrials.gov) | June 2018 | 12/4/2018 | COLISURG Prospective, Multicentric Cohort | COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity. | Ulcerative Colitis | Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis | Hospices Civils de Lyon | NULL | Not yet recruiting | 18 Years | N/A | All | 330 | France | |
| 8 | NCT03594708 (ClinicalTrials.gov) | April 30, 2018 | 19/1/2018 | Immunonutrition in Ulcerative Colitis | Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Nutrition supplement;Dietary Supplement: Placebo supplement | Baptist Memorial Health Care Corporation | NULL | Unknown status | 18 Years | N/A | All | 30 | N/A | United States |
| 9 | NCT03172195 (ClinicalTrials.gov) | October 11, 2017 | 23/5/2017 | Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up | Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up | Colitis, Ulcerative | Procedure: rectosigmoidoscopy;Biological: biopsies;Biological: blood sample | Centre Hospitalier Universitaire de Saint Etienne | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | France |
| 10 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 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 |
| 11 | NCT02742597 (ClinicalTrials.gov) | January 12, 2016 | 21/3/2016 | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity | Behavioral: TIP / IMPACT Plus Care Coordination | Lawson Health Research Institute | Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital | Active, not recruiting | 18 Years | 80 Years | All | 1980 | N/A | Canada |
| 12 | NCT02575040 (ClinicalTrials.gov) | May 2015 | 6/10/2015 | Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease | Ulcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction) | Biological: Fecal microbiota transplantation | Gulhane Military Medical Academy | NULL | Recruiting | 18 Years | N/A | Both | 60 | Phase 3 | Turkey |
| 13 | NCT02092285 (ClinicalTrials.gov) | May 9, 2014 | 18/3/2014 | Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) | Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis | Ulcerative Colitis | Drug: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 205 | Phase 4 | United Kingdom |
| 14 | EUCTR2013-004583-56-GB (EUCTR) | 28/01/2014 | 23/12/2013 | Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis | Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Simponi INN or Proposed INN: golimumab | MSD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 15 | EUCTR2011-002411-29-PL (EUCTR) | 19/12/2013 | 17/10/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 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 |
| 16 | EUCTR2011-002411-29-CZ (EUCTR) | 15/11/2013 | 16/09/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 17 | EUCTR2011-002411-29-SK (EUCTR) | 11/11/2013 | 14/10/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 18 | EUCTR2011-002411-29-ES (EUCTR) | 10/08/2012 | 18/10/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 19 | EUCTR2011-002411-29-FI (EUCTR) | 29/06/2012 | 11/06/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 20 | EUCTR2011-002411-29-AT (EUCTR) | 26/06/2012 | 01/02/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 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 |
| 21 | EUCTR2011-002411-29-PT (EUCTR) | 01/06/2012 | 03/01/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 22 | EUCTR2011-002411-29-DE (EUCTR) | 11/05/2012 | 11/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 23 | EUCTR2011-002411-29-GB (EUCTR) | 03/05/2012 | 07/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 24 | NCT01550965 (ClinicalTrials.gov) | May 2012 | 8/3/2012 | A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting | Ulcerative Colitis | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 75 Years | All | 463 | Phase 3 | Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 25 | EUCTR2011-002411-29-SE (EUCTR) | 26/04/2012 | 13/10/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 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 |
| 26 | EUCTR2011-002411-29-IE (EUCTR) | 30/03/2012 | 09/02/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 27 | EUCTR2011-002411-29-DK (EUCTR) | 30/03/2012 | 28/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 28 | EUCTR2011-002411-29-BE (EUCTR) | 07/03/2012 | 23/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 29 | EUCTR2011-002411-29-IT (EUCTR) | 20/02/2012 | 07/03/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | ABBOTT GMBH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden | |||
| 30 | EUCTR2011-002411-29-GR (EUCTR) | 09/01/2012 | 07/12/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 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 |
| 31 | NCT00621257 (ClinicalTrials.gov) | January 2008 | 11/2/2008 | Vitamin D Levels in Children With IBD | Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Dietary Supplement: ergocalciferol;Dietary Supplement: Cholecalciferol | Boston Children’s Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Crohn's and Colitis Foundation;NASPGHAN Foundation | Terminated | 5 Years | 21 Years | All | 134 | N/A | United States |
| 32 | EUCTR2006-004162-13-DE (EUCTR) | 27/02/2007 | 06/10/2006 | Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients | Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients | Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano. MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease | Trade Name: Salofalk 4g/60ml Klysma INN or Proposed INN: MESALAZINE | Charité Universitätsmedizin, Campus Charité Mitte | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Germany |
| 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 | NCT04378153 (ClinicalTrials.gov) | August 25, 2020 | 4/5/2020 | Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy | A Master Protocol to Test the Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy (SIMPLIFY) | Cystic Fibrosis | Other: Discontinuation of hypertonic saline (HS);Other: Continuation of hypertonic saline (HS);Other: Discontinuation of dornase alfa (dnase);Other: Continuation of dornase alfa (dnase) | David Nichols, MD | Cystic Fibrosis Foundation;Dartmouth-Hitchcock Medical Center;University of Washington | Recruiting | 12 Years | N/A | All | 800 | N/A | United States |
| 2 | NCT04437641 (ClinicalTrials.gov) | October 22, 2019 | 26/3/2020 | Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children | Impact of Pediatrician Intervention on the Smoking Habits of Parents of Children With Cystic Fibrosis, Type 1 Diabetes or Children Hospitalized for a First Episode of Bronchiolitis. | Tobacco Consumption;Bronchiolitis | Other: Tobacco questionnaire | University Hospital, Toulouse | NULL | Recruiting | 18 Years | 65 Years | All | 600 | France | |
| 3 | NCT04056702 (ClinicalTrials.gov) | September 5, 2019 | 27/7/2019 | Impact of Triple Combination CFTR Therapy on Sinus Disease. | Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular Changes | Cystic Fibrosis | Drug: Elexacaftor-tezacaftor-ivacaftor exposure | Jennifer Taylor-Cousar | Cystic Fibrosis Foundation | Active, not recruiting | 18 Years | 89 Years | All | 30 | United States | |
| 4 | NCT03795363 (ClinicalTrials.gov) | April 10, 2019 | 28/12/2018 | Orkambi Treatment in 2 to 5 Year Old Children With CF | Nutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del Mutations | Cystic Fibrosis | Drug: Orkambi | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Recruiting | 2 Years | 5 Years | All | 32 | United States | |
| 5 | NCT03783286 (ClinicalTrials.gov) | February 6, 2019 | 18/12/2018 | Ivacaftor Treatment in 6 Month to 2 Year Old CF Subjects | Nutritional Impact of Ivacaftor Treatment in 6 Month to 2 Year Old Children With CF Gating Mutations | Cystic Fibrosis | Drug: Ivacaftor | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Recruiting | 6 Months | 2 Years | All | 18 | United States | |
| 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 |
| 6 | NCT03625466 (ClinicalTrials.gov) | August 10, 2018 | 7/8/2018 | A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 51 | Phase 2 | Germany |
| 7 | EUCTR2017-003761-99-DE (EUCTR) | 27/06/2018 | 19/02/2018 | A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 8 | NCT03492567 (ClinicalTrials.gov) | April 25, 2018 | 3/4/2018 | Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors. | Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors. | Cystic Fibrosis | Biological: Blood test | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Completed | 18 Years | N/A | All | 25 | N/A | France |
| 9 | NCT02750501 (ClinicalTrials.gov) | July 20, 2016 | 20/4/2016 | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding | Cystic Fibrosis | Device: RELiZORB (immobilized lipase) cartridge;Other: Impact Peptide 1.5 | Alcresta Therapeutics, Inc. | Cystic Fibrosis Foundation | Completed | 4 Years | N/A | All | 49 | N/A | United States |
| 10 | NCT02734810 (ClinicalTrials.gov) | June 2016 | 6/4/2016 | SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis | A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Liprotamase Powder for Oral Solution | Anthera Pharmaceuticals | NULL | Completed | N/A | N/A | All | 15 | Phase 3 | United States |
| 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 |
| 11 | NCT02496780 (ClinicalTrials.gov) | August 2015 | 18/6/2015 | The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients | The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients | Cystic Fibrosis | Drug: novolog insulin;Drug: levemir insulin;Drug: placebo | University of Minnesota | NULL | Recruiting | 10 Years | 25 Years | All | 80 | Phase 2;Phase 3 | United States |
| 12 | NCT02569229 (ClinicalTrials.gov) | June 2015 | 12/8/2015 | Glucose Tolerance in Children With Cystic Fibrosis | Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis | Glucose Intolerance;Cystic Fibrosis | Other: Diagnostics for glucose tolerance with 3 different methods. | Christoph Saner | University Hospital Inselspital, Berne | Active, not recruiting | 10 Years | 20 Years | All | 14 | Switzerland | |
| 13 | EUCTR2011-000801-39-ES (EUCTR) | 25/07/2014 | 25/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens? eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Ireland;Austria;Germany;Italy;Sweden | ||
| 14 | EUCTR2011-000801-39-AT (EUCTR) | 11/06/2014 | 24/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Hungary;Ireland;Austria;Germany;Italy;Sweden | ||
| 15 | EUCTR2011-000801-39-HU (EUCTR) | 22/05/2014 | 03/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Hungary;Ireland;Germany;Italy;Sweden | ||
| 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 |
| 16 | NCT02048592 (ClinicalTrials.gov) | September 2013 | 16/12/2013 | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Cystic Fibrosis;Malnutrition;Oxidative Stress | Dietary Supplement: Impact-Nutridrink;Dietary Supplement: Nutridrink-Impact | University Hospital, Motol | NULL | Recruiting | 18 Years | 40 Years | Both | 30 | Phase 4 | Czech Republic |
| 17 | EUCTR2011-000801-39-IE (EUCTR) | 07/05/2013 | 12/02/2013 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Ireland;Germany;Italy;Sweden | ||
| 18 | EUCTR2011-000801-39-IT (EUCTR) | 20/06/2012 | 21/06/2012 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens'eggs building a barrier in the respiratory tract against Pesudomonas germ in order to preventi infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | MUKOVISZIDOSE E.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Germany;Italy;Sweden | ||
| 19 | EUCTR2011-000801-39-BE (EUCTR) | 26/04/2012 | 09/01/2012 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 20 | EUCTR2011-000801-39-SE (EUCTR) | 08/02/2012 | 13/12/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 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 |
| 21 | EUCTR2011-000801-39-DE (EUCTR) | 31/08/2011 | 04/04/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 22 | NCT01031706 (ClinicalTrials.gov) | September 2009 | 11/12/2009 | Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis | Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline;Drug: Placebo | University of North Carolina, Chapel Hill | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 5 Years | 12 Years | All | 23 | N/A | United States |