52 NOWE BADANIA KLINICZNE - aktualizacja z dnia 16.02.2020 r.

W dniu 16.02.2020 r. sfinalizowano kolejną aktualizację przewodnika po badaniach klinicznych BadX.

Poniższa tabela zawiera listę badań klinicznych, które zostały zakończone bądź zamknęły proces rekrutacji (usunięto*) oraz nowe badania, które pojawiły się na rynku (dodano*). 

Lista wprowadzonych zmian jest następująca: 

Astma: 

Dodano: 
OpInh (Optimal Type of Inhaler in Cough Variant- or Cough Predominant Asthma)
Inhtech (Factors Influencing on Correctness of Inhalation Technique.)
THUNDER (Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma)
MATIC (Mite Allergy Trial In Children)

 

Usunięto:
QMF149 (A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma)
MRx-4DP0004 (A Study of MRx-4DP0004 in Asthma)
PONENTE (Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma)
SOURCE (Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma)
FlutFuro (Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year)
BIOSAMOT (BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment)

Atopowe zapalenie skóry: 

Dodano: 
PF-067 AtD (Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis)
UpaAtD (Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis)
MEDI3506 AtD (Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis)
REGN3500 AtD 2 (Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis)
REGN3500 AtD (Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis)

Usunięto:
ECZTRA 6 (Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis)
ECZTRA 7 (Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis Who Are Not Adequately Controlled With or Have Contraindications to Oral Cyclosporine A)
GUANA (A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis)
JADE Compare (Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy)
MSTT1041A (A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis)
PF-04965842 AtD (Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects)
WBCryo (Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators)
Choroba Alzheimera:

Dodano: 
AVP-786 Alz (Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type)
Choroba Leśniowskiego-Crohna:

Dodano: 
GIANT (Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease)

Usunięto:
SEAVUE (Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year)
Choroba zwyrodnieniowa stawów: 

Dodano: 
MONOVISC Ankle (MONOVISC for Ankle Joint Pain Relief)
MONOVISC Shoulder (MONOVISC for Shoulder Joint Pain Relief)
MONOVISC Hip (MONOVISC for Hip Joint Pain Relief)
REGN5069 (A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee)

Usunięto:
FasinumabOsteo (Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee)
Cukrzyca:

Dodano: 
PROTECT (Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab)
PF-06882961 Db (A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus)
MEDI7352 Db (Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy)
BLOSSOM (Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life)

Usunięto:
GLITTER 1 (Gan & Lee Insulin Glargine Target Type (1) Evaluating Research)
AMPLITUDE-D (Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin)
SCORED (Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk)
SUSTAIN 11 (A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes)
SUSTAIN FORTE (A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes)
Jaskra:

Dodano: 
BimaSRGlauc (Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-angle Glaucoma or Ocular Hypertension)

Usunięto:
Bimatoprost SR (Long-term Safety and Efficacy Extension Trial of Bimatoprost SR)
Łuszczyca i łuszczycowe zapalenie stawów:

Dodano: 
PF-06700841 PsO (Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis)
PF-06826647 (A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis)
SecuExt (An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA))

Usunięto:
BMS-986165 PsA (Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA))
COSMOS (A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy)
HaloFoam (Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis)
IMMpact2 (A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies))
VOLTAIRE-X (The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis.)
Migotanie przedsionków:

Dodano: 
HighRF-AF (High RF Energy Ablation of Atrial Fibrillation)
Nadciśnienie płucne:

Dodano: 
A DUE (Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH))
SelexiPedPH Add-on (A Study of  as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension)

Usunięto:
PATENT-CHILD (Riociguat in Children With Pulmonary Arterial Hypertension (PAH))
Niealkoholowa stłuszczeniowa choroba wątroby: 

Dodano: 
CC-90001 NAFLD (Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and Stage 3 or Stage 4 Liver Fibrosis)

Usunięto:
NATIVE (Phase 2b Study in NASH to Assess IVA337)
Otyłość: 

Dodano: 
6-10-14 (Community Based Obesity Prevention and Treatment Programme "6-10-14 for Health")
WELCOME (Diet for the Maintenance of Weight Loss and Metabolic Health in Obese Postmenopausal Women)

Usunięto:
NNC0174-0833 (Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.)
Przewlekła choroba nerek: 

Dodano: 
Dapa-CKD (A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease)
HAV PChN (Safety and Efficacy Assessment of HAV (Manufactured Using Large-scale System) in Patients Needing Vascular Access for Dialysis)
KALM (CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus)
KALM-2 (CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus)

Usunięto:
ASCEND-NHQ (Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life)
SCORED PChN (Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk)
Rak jelita grubego:

Dodano: 
MycoCRC (Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population)
RomiTrhomb (Study of Romiplostim for Chemo-induced Thrombocytopenia in Adults Subjects With Gastrointestinal or Colorectal Cancer)
PIVOT-02 CRC (A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors)

Usunięto:
PRECONNECT (A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).)
Reumatoidalne zapalenie stawów: 

Dodano: 
CT-P17 A-i (A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis)
ABX464 2 RZS (Study Evaluating the One-Year Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis)
SKI-O-703 RZS (A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.)
ABX464 RZS (Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis)
PF-064vHumira (A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis)
MANTA-RAy RZS (Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis)
BraneRZS (Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis)

Usunięto:
ABBV-599 Comb (A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis.)
AMG 592 (Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis)
JHL1101 (A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis)
Stwardnienie rozsiane: 

Dodano: 
NBSS&Quali PL (Polish Translation and Validation of NBSS, Qualiveen and SF-Qualiveen)
OcrePed SM (A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis)
Antelope (Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®)

Usunięto:
CONSONANCE
(A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis)
OcreMS (Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS))
POINT (Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate)
Toczeń rumieniowaty układowy: 

Dodano: 
PF-06700841 SLE (A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE))
BraneSLE (Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis)
ObiSLE (A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis)
Wrzodziejące zapalenie jelita grubego: 

Dodano: 
ABX464 (Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis)
ELEVATE UC 52 (Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis)
Oral BT-11 UC (Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis)

Usunięto:
Etro vs Ada #1 (A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1))
Etro vs Ada #2 (A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2))
OCTAVE2 (A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission)