Drensteinfurt, Germany
A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting
Phase
N/ASpan
241 weeksSponsor
AbbVieEhringshausen
Recruiting
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.
Phase
N/ASpan
242 weeksSponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyEhringshausen
Recruiting
Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement
This study is a prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and in the spine on MRI in patients with active axial PsA. Eligible patients (n=80) will be randomized 1:1 to receive either Tofacitinib 5mg orally twice daily or placebo for a 12-week period. After week 12, all patients will receive Tofacitinib 5mg orally twice daily for another 12 weeks. The study duration will include a 6-week screening period, a 24-week treatment period and a safety follow-up period of 4 weeks. Patients will be closely monitored throughout the study on a total of 11 visits. Safety data will be collected in the form of adverse events, vital parameters, physical examinations, and laboratory parameters throughout the study. The baseline MRI of the whole spine and sacroiliac (SI) joints will be performed within the 6-week screening period to confirm the presence of active inflammation (bone marrow edema) compatible with Spondyloarthritis (will be assessed by a central reader), at week 12 to evaluate the primary study endpoint, and at week 24 to evaluate the secondary endpoint. The primary study endpoint will be an improvement of the total Berlin MRI score for sacroiliac joints and spine at week 12 as compared to baseline.
Phase
2Span
178 weeksSponsor
Charite University, Berlin, GermanyEhringshausen
Recruiting
A Non-interventional, Prospective Study With Benralizumab
This is a prospective observational study to investigate the asthma control and health realted quality of life (HRQL) of benralizumab treated patients in routine clinical practice, their asthma medication intake, and their changes in asthma medication during the study, up to 52 weeks. The asthma control will be analyzed by using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at different timepoints during the study period either collected by the investigator or self-reported by the patient. In addition, health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire (miniAQLQ) which is collected by the investigator. To investigate the medication intake and assess the changes in asthma medication, the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study.
Phase
N/ASpan
127 weeksSponsor
AstraZenecaEhringshausen
Recruiting
A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
Phase
N/ASpan
201 weeksSponsor
Novartis PharmaceuticalsEhringshausen
Recruiting
A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING
Phase
N/ASpan
217 weeksSponsor
AbbVieEhringshausen
Recruiting