Clinical efficacy of complement C5a inhibition by IFX‐1 in hidradenitis suppurativa: an open‐label single‐arm trial in patients not eligible for adalimumab

2020 ◽  
Vol 183 (1) ◽  
pp. 176-178 ◽  
Author(s):  
E.J. Giamarellos‐Bourboulis ◽  
M. Argyropoulou ◽  
T. Kanni ◽  
T. Spyridopoulos ◽  
I. Otto ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Hidradenitis Suppurativa ◽  
Open Label ◽  
Complement C5a

Continuous Weekly Adalimumab is the Optimal Long-Term Strategy for Patients with Moderate-to-Severe Hidradenitis Suppurativa: Results from the PIONEER Open Label Extension Trial

2017 ◽  
Vol 1 ◽  
pp. s129
Author(s):  
Alexa B Kimball ◽  
Martin M Okun ◽  
Gerit Mulder
Keyword(s):  
Hidradenitis Suppurativa ◽  
Open Label ◽  
Open Label Extension ◽  
Extension Trial

Abstract Not Available Disclosures: Study supported by AbbVie.

Review on the Clinical Pharmacology of Hydroxychloroquine Sulfate for the Treatment of COVID-19

2020 ◽  
Vol 21 (6) ◽  
pp. 427-435 ◽  
Author(s):  
Cheng Cui ◽  
Siqi Tu ◽  
Valerie Sia Jie En ◽  
Xiaobei Li ◽  
Xueting Yao ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Clinical Efficacy ◽  
Relevant Literature ◽  
The United States ◽  
Efficacy And Safety ◽  
Open Label ◽  
Infected People ◽  
Treatment Regimens ◽  
Therapeutic Drugs

Background: As the number of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infected people is greatly increasing worldwide, the international medical situation becomes very serious. Potential therapeutic drugs, vaccine and stem cell replacement methods are emerging, so it is urgent to find specific therapeutic drugs and the best treatment regimens. After the publications on hydroxychloroquine (HCQ) with anti- SARS-COV-2 activity in vitro, a small, non-randomized, open-label clinical trial showed that HCQ treatment was significantly associated with reduced viral load in patients with coronavirus disease-19 (COVID-19). Meanwhile, a large prophylaxis study of HCQ sulfate for COVID-19 has been initiated in the United States. HCQ offered a promising efficacy in the treatment of COVID-19, but the optimal administration is still being explored. Methods: We used the keyword "hydroxychloroquine" to conduct a literature search in PubMed to collect relevant literature on the mechanism of action of HCQ, its clinical efficacy and safety, pharmacokinetic characteristics, precautions for clinical use and drug interactions to extract and organize information. Results: This paper reviews the mechanism, clinical efficacy and safety, pharmacokinetic characteristics, exposureresponse relationship and precautions and drug interactions of HCQ, and summarizes dosage recommendations for HCQ sulfate. Conclusion: It has been proved that HCQ, which has an established safety profile, is effective against SARS-CoV-2 with sufficient pre-clinical rationale and evidence. Data from high-quality clinical trials are urgently needed worldwide.

Open‐label, investigator‐initiated, single‐site exploratory trial evaluating secukinumab, an anti‐interleukin‐17A monoclonal antibody, for patients with moderate‐to‐severe hidradenitis suppurativa

2019 ◽  
Vol 181 (3) ◽  
pp. 609-611 ◽  
Author(s):  
L. Prussick ◽  
B. Rothstein ◽  
D. Joshipura ◽  
A. Saraiya ◽  
Y. Turkowski ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Hidradenitis Suppurativa ◽  
Single Site ◽  
Open Label ◽  
Exploratory Trial ◽  
Interleukin 17A

scholarly journals Clinical efficacy of different dosage forms containing vitamin D: design and study outcomes of a randomized, comparative clinical trial

2020 ◽  
Vol 7 (3) ◽  
pp. 176
Author(s):  
Nidhi Sapkal ◽  
Gaurav Chhaya ◽  
Milan Satya ◽  
Dhara Shah
Keyword(s):  
Vitamin D ◽  
Clinical Efficacy ◽  
Dosage Forms ◽  
Oral Solution ◽  
Blood Levels ◽  
Open Label ◽  
Soft Gelatin Capsules ◽  
25 Hydroxy Vitamin D ◽  
Group A ◽  
Group B

<p class="abstract"><strong>Background:</strong> Different dosage forms of vitamin D like tablets, soft gelatin capsules, oral granules, powders, solutions and thin films are available. The objective of the present study was to evaluate and compare the clinical efficacy of three different dosage forms of vitamin D3 namely, orally disintegrating strips, oral granules and oral solution.</p><p class="abstract"><strong>Methods:</strong> An open label, single centre, prospective, randomized, parallel group, comparative study was conducted for a period of 4 months. The study participants were divided into three groups (A, B, C) and received the respective treatments (orally disintegrating strips, n=20; granules, n=20; oral nano solution, n=10) for the study period. The estimation of blood levels of 25-hydroxy vitamin D [25(OH)D<sub>3</sub>] in all the subjects at day 0, 60 and 120 was carried out.</p><p class="abstract"><strong>Results:</strong> The normalization level of 25(OH)D<sub>3 </sub>achieved by the subjects in group A, group B and group C was 100%, 83.3% and 90% respectively after 90 days. Comparison of 25(OH)D<sub>3 </sub>level in all three groups showed significant increase at day 60. The levels were maintained at day 90 and 120 even after drastic reduction in dosage in Group A and group C. On day 120, the dose reduction was in the order of group A&gt;group C&gt;group B.</p><p class="abstract"><strong>Conclusions: </strong>All the three formulations showed increase in the level of 25(OH)D<sub>3. </sub>It can be concluded that oral disintegrating strips of 25(OH)D<sub>3</sub> are clinically more efficient than other conventional dosage forms.</p>

P.1.125 An open-label study of the clinical efficacy of tianeptine for depression: One center results of a multicenter study

1997 ◽  
Vol 7 ◽  
pp. S174-S175
Author(s):  
Z. Tunca ◽  
T. Alkin ◽  
H. Fidaner ◽  
K. Alptekin ◽  
C. Cimilli
Keyword(s):  
Clinical Efficacy ◽  
Multicenter Study ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Early Efficacy Analysis of Cluster and Conventional Immunotherapy in Patients With Allergic Rhinitis

2019 ◽  
pp. 014556131986337
Author(s):  
Jieqing Yu ◽  
Nongping Zhong ◽  
Qing Luo ◽  
Yuanhua Liu ◽  
Huarong Yi ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Clinical Efficacy ◽  
Maintenance Dose ◽  
Open Label ◽  
Prick Test ◽  
Efficacy Analysis ◽  
Cluster Immunotherapy ◽  
Symptom Scores ◽  
Group A ◽  
Group D

Background: Specific immunotherapy is an important immune-modifying treatment for patients with allergic rhinitis (AR). We compared the early efficacy and safety of cluster and conventional immunotherapies for patients with AR. Methods: One hundred forty-nine patients with persistent AR were enrolled in a randomized and open-label trial and were divided into the following 4 groups: 60 children treated conventionally, 33 children treated using the cluster schedule, 23 adults treated conventionally, and 33 adults treated using the cluster schedule. Patients in the cluster groups reached the maintenance dose within 6 weeks, while those receiving conventional therapy reached the maintenance dose within 14 weeks. Symptom scores and skin prick test scores (SPTs) were used to evaluate clinical efficacy and adverse reactions. Results: After buildup phase of treatment, symptom scores, and SPTs were significantly lower than those prior to treatment in each group ( P < .05). No significant differences were found in the efficacy of nasal symptoms scores among four groups ( P > .05).However, the efficacy of SPTs using conventional schedule was higher than cluster schedule in children groups (group A and B, 57.7 vs 30.2%, P = .001). Besides, the efficacy of SPTs in adults was higher than children when using the cluster treatment (group D and B, 53.0 vs 30.2%, P = .008). No severe adverse reaction occurred. Conclusions: Conventional and cluster immunotherapy schedules have similar efficacies, which do not vary with age; both schedules are safe and reliable. Also, SPT facilitate evaluation of clinical efficacy.

scholarly journals A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Timothy Devos ◽  
Tatjana Geukens ◽  
Alexander Schauwvlieghe ◽  
Kevin K. Ariën ◽  
Cyril Barbezange ◽  
...  
Keyword(s):  
Treatment Group ◽  
Phase Ii ◽  
Clinical Efficacy ◽  
Active Treatment ◽  
Standard Of Care ◽  
Active Treatment Group ◽  
Proof Of Concept ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Phase

Abstract Background The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown. Methods DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 h after randomization, with a second administration of 2 units 24 to 36 h after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma. Discussion This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection. Trial registration ClinicalTrials.govNCT04429854. Registered on 12 June 2020 - Retrospectively registered.

scholarly journals Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial

2020 ◽  
Vol 9 (9) ◽  
pp. 3023
Author(s):  
Youngjae Park ◽  
Yoon Jae Lee ◽  
Jung Hee Koh ◽  
Jennifer Lee ◽  
Hong-Ki Min ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Clinical Efficacy ◽  
Stromal Vascular Fraction ◽  
Skin Fibrosis ◽  
Therapeutic Modality ◽  
Efficacy And Safety ◽  
Open Label ◽  
Adipose Tissues ◽  
Hand Disability

Background: Stromal vascular fraction (SVF) has recently emerged as a potential therapeutic modality, due to its multipotent cellular components in tissue regeneration. Systemic sclerosis (SSc) is a progressive autoimmune disease that results in hand disability by skin fibrosis and microangiopathies. We performed an open-label study to investigate the efficacy and safety of SVF injection in SSc patients (Clinical Trial number: NCT03060551). Methods: We gathered 20 SSc patients with hand disability, planning for a 24-week follow-up period. SVF was extracted from autologous adipose tissues, processed by the closed system kit, and injected into each finger of SSc patients. We observed various efficacy and safety profiles at each follow-up visit. Results: Among the 20 initially enrolled patients, eighteen received SVF injection, and were completely followed-up for the whole study period. Patients received 3.61 × 106 mesenchymal stem cells into each finger on average. Skin fibrosis, hand edema, and quality of life were significantly improved, and 31.6% of active ulcers were healed at 24 weeks after injections. Semiquantitative results of nailfold capillary microscopy were ameliorated. There was no single serious adverse event related to the procedure. Conclusions: Injection of SVF derived from autologous adipose tissues is tolerable, and shows clinical efficacy in SSc patients.

scholarly journals Secukinumab in the treatment of moderate to severe hidradenitis suppurativa: Results of an open-label trial

2020 ◽  
Vol 82 (6) ◽  
pp. 1524-1526 ◽  
Author(s):  
Rachel G. Casseres ◽  
Lisa Prussick ◽  
Pedro Zancanaro ◽  
Brooke Rothstein ◽  
Deep Joshipura ◽  
...  
Keyword(s):  
Hidradenitis Suppurativa ◽  
Open Label ◽  
Open Label Trial
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