Impact ( DrugBank: - )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 40 |
| 50 | 皮膚筋炎／多発性筋炎 | 1 |
| 53 | シェーグレン症候群 | 6 |
| 85 | 特発性間質性肺炎 | 4 |
| 299 | 嚢胞性線維症 | 19 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04269993 (ClinicalTrials.gov) | May 18, 2022 | 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 | Recruiting | 18 Years | 65 Years | All | 76 | Phase 2 | United States |
| 2 | NCT04688398 (ClinicalTrials.gov) | January 20, 2022 | 14/12/2020 | Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis | Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis | Polyarthritis | Dietary Supplement: Seal oil;Dietary Supplement: Control | Laval University | Ministry of Agriculture, Fisheries and Food, Quebec;Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc. | Recruiting | 18 Years | N/A | All | 130 | N/A | Canada |
| 3 | EUCTR2021-000880-63-SE (EUCTR) | 11/03/2021 | 23/02/2021 | COVID-19 vaccine in patients with rheumatic diseases: The impact of treatments on the vaccine response protection against infection (COVID19-REUMA) | COVID-19 vaccine in patients with inflammatory rheumatic diseases: The impact of immunomodulating treatments on the antibody response, T cells response and protection against infection (COVID19-REUMA) - COVID19-REUMA | rheumatoid arthritis, SLE, systemic vasculitis, systemic sclerosis, spondylarthritis;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Comirnaty Product Name: Comirnaty INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified) Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19) Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) | Skåne University Hospital, department of rheumatology in Lud and Malmö | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 868 | Phase 4 | Sweden | ||
| 4 | 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 | Withdrawn | 18 Years | 70 Years | All | 0 | N/A | France |
| 5 | 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 | ||
| 6 | 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 | |
| 7 | 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 | |
| 8 | NCT03810144 (ClinicalTrials.gov) | October 22, 2018 | 26/12/2018 | Impact of Guided Care With the Vectra DA Multi-biomarker Disease Activity (MBDA) Blood Test | Impact of Guided Care With the Vectra DA Multi-biomarker Disease Activity (MBDA) Blood Test on Clinical Outcomes and Pharmaceutical Utilization in Patients With Rheumatoid Arthritis: A Prospective, Randomized Study | Rheumatoid Arthritis | Genetic: Vectra DA MBDA Test | Sequenom, Inc. | LabCorp | Active, not recruiting | 18 Years | N/A | All | 500 | United States | |
| 9 | 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 |
| 10 | 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 | |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 | |
| 14 | 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 | Completed | 18 Years | N/A | All | 300 | Phase 4 | NULL |
| 15 | 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 | |
| 16 | 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 | Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial - 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 |
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 |
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial - 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 |
| 31 | 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 | |
| 32 | 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 | Completed | 18 Years | N/A | All | 232 | Phase 4 | France |
| 33 | 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 |
| 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 |
| 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 | Not Recruiting | Female: yes Male: yes | 101 | Phase 4 | 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 |
50. 皮膚筋炎／多発性筋炎
臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
| 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 |
53. シェーグレン症候群
臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
| 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 | Completed | 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 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 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 | Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers - Impact of CYP2A6 and CHRM3 polymorphisms on the PK/PD of pilocarpine | 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 |
| 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 |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| 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 | ChiCTR2200058868 | 2022-04-20 | 2022-04-18 | Safety, tolerability, and drug administration of the suspension in single/multiple doses in Chinese healthy subjects Phase I clinical study of TDI01 kinetic characteristics and food effects | Safety, tolerability, and drug administration of the suspension in single/multiple doses in Chinese healthy subjects Phase I clinical study of TDI01 kinetic characteristics and food effects | Idiopathic pulmonary fibrosis | Single dose study:Single dose study;Food impact research:Food impact research;multiple dose study:multiple dose study; | Chinese PLA General Hospital | NULL | Pending | Both | Single dose study:30;Food impact research:12;multiple dose study:20; | Phase 1 | China | ||
| 2 | ChiCTR2000031386 | 2020-04-01 | 2020-03-29 | The impact of NAC treatment in IPF patients in mainland China: a retrospective study | The impact of NAC treatment in IPF patients in mainland China: a retrospective study | idiopathic pulmonary fibrosis | Study group:acetylcysteine 0.6 tid po.;control group:did not take NAC or other antifibrotic drugs; | Shanghai Pulmonary Hospital, Tongji University School of Medicine | NULL | Recruiting | Both | Study group:348;control group:174; | China | |||
| 3 | EUCTR2014-000861-32-DE (EUCTR) | 01/12/2015 | 02/09/2015 | Standard-armed controlled study to assess the impact of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF) | Exploring Efficacy and Safety of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)A randomized, double-blind, placebo-controlled, parallel group, multi-center, phase II trial - RELIEF | 1.Fibrotic NSIP., 2.Chronic Hypersensitivity Pneumonitis 3. Lung fibrosis associated with collagen / vascular diseases, 4.Asbestos-induced lung fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10022612;Term: Interstitial lung fibrosis;System Organ Class: 100000004855 MedDRA version: 20.0;Classification code 10035754;Term: Pneumonitis hypersensitivity;Classification code 10025088;Term: Lung fibrosis;Classification code 10022617;Term: Interstitial pneumonia;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet® (Pirfenidon) Product Name: Esbriet® (Pirfenidon) Product Code: PZN 8881655(RochePharma AG) INN or Proposed INN: PIRFENIDONE | Justus Liebig Universität Giessen | NULL | Not Recruiting | Female: yes Male: yes | 374 | Phase 2 | Germany | ||
| 4 | EUCTR2014-003423-21-BE (EUCTR) | 29/09/2014 | 29/08/2014 | Evaluation of impact of inhaled nitric oxide on pulmonary vessel blood volume measured by high resolution computed tomography (HRCT) in subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in subjects with WHO Group 3 Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) on Long-Term Oxygen Therapy (LTOT) (Part 2). | An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2). | Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10009033;Term: Chronic obstructive pulmonary disease;Classification code 10037400;Term: Pulmonary hypertension;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: INO INN or Proposed INN: NITRIC OXIDE | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | Phase 1;Phase 2 | Belgium |
299. 嚢胞性線維症
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | NCT05663255 (ClinicalTrials.gov) | March 1, 2023 | 15/12/2022 | Effectiveness of CFTR Modulators According to Co-therapy | Is Effectiveness of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators Impacted by Co-therapy? A Population-based Comparative Effectiveness Study Using Data From French Cystic Fibrosis Registry Linked to French National Healthcare Insurance Database | Cystic Fibrosis | Drug: Discontinuation of respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics) | Hospices Civils de Lyon | NULL | Not yet recruiting | 6 Years | N/A | All | 1990 | NULL | |
| 2 | NCT05523180 (ClinicalTrials.gov) | September 1, 2022 | 22/8/2022 | A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life | A Prospective, Randomized, Double-blinded, Placebo-controlled Study Evaluating the Safety and Impact of resB® Lung Support on Quality of Life in Adult Volunteers With Chronic Obstructive Pulmonary Disease or Non-cystic Fibrosis Bronchiectasis | Chronic Obstructive Pulmonary Disease;Non-cystic Fibrosis Bronchiectasis | Dietary Supplement: Probiotic;Other: Placebo | ResBiotic Nutrition, Inc. | Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | Recruiting | 18 Years | 80 Years | All | 50 | N/A | United States |
| 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 | Recruiting | 18 Years | 89 Years | All | 31 | 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 | Completed | 2 Years | 5 Years | All | 28 | United States | |
| 5 | NCT03783286 (ClinicalTrials.gov) | February 6, 2019 | 18/12/2018 | Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects | Nutritional Impact of Ivacaftor Treatment in 4 Month to 2 Year Old Children With CF Gating Mutations | Cystic Fibrosis | Drug: Ivacaftor | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Completed | 4 Months | 2 Years | All | 15 | United States | |
| 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 | Not Recruiting | 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 | 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 |
| 10 | 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 | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Belgium;Spain;Ireland;Austria;Germany;Italy;Sweden | ||
| 11 | 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 | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 12 | EUCTR2011-000801-39-HU (EUCTR) | 22/05/2014 | 03/04/2014 | 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 | 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 | ||
| 13 | 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 |
| 14 | 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 | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 15 | EUCTR2011-000801-39-IT (EUCTR) | 20/06/2012 | 21/06/2012 | 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 | 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 | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 |