Clinical trials: Biological Therapy
Arthritis, Rheumatoid, Biological Therapy
Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population.
- Trial name
- SINNO-RA (NCT04117165)
- Testing
- Biotherapy Prescription with SinnoTest® software, Patient Current Care
- Where
- 16 sites in France
- Sponsor
- University Hospital, Grenoble
Chronic Plaque Psoriasis
Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg…
- Trial name
- NCT01200264
- Testing
- apremilast
- Where
- United States
- Sponsor
- Duke University
Prostate Cancer Metastatic, Hormone Refractory Prostate Cancer
Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters)…
- Conditions
- Prostate Cancer Metastatic, Hormone Refractory Prostate Cancer, Castration-resistant Prostate Cancer
- Trial name
- NCT01487863
- Testing
- sipuleucel-T, abiraterone acetate
- Where
- 21 sites in United States
- Volunteers
- 69 people
- Sponsor
- Dendreon
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy
This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic…
- Trial name
- TOSCA (NCT02001987)
- Testing
- Tocilizumab, Methotrexate, csDMARDs
- Where
- 32 sites in France
- Volunteers
- 139 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Metastatic Cancer
Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.
- Trial name
- NCT00301106
- Testing
- adenovirus-mediated human interleukin-12
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Max Sung
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
1. Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial. The study is designed to evaluate and compare the efficacy and safety of two biologic-based induction regimens against…
- Trial name
- NCT07340463
- Testing
- Glucocorticoids, belimumab, Telitacicept
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Nanjing University School of Medicine
Advanced Solid Tumors
Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System
This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well…
- Trial name
- SINGULARITY (NCT06824792)
- Testing
- Biologically-informed multi-agent system (Quasar) including targeted drugs Osimertinib, chemotherapy pemetrexed, immunotherapy pembrolizumab et al. approved by China CDE.
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- NING LI
Polyarthritis; Rheumatoid
Performance of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
The management of rheumatoid arthritis is based on the prescription of disease-modifying anti-rheumatic drugs (DMARDs) to induce clinical and biological remission.
- Trial name
- NCT06186375
- Testing
- Patients with planned biotherapy
- Where
- 4 sites in France
- Volunteers
- 239 people
- Sponsor
- CEN Biotech
Covid19
Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells
This is a randomized phase II placebo controlled clinical trial. Active arm: Allogeneic Wharton's jelly derived MSCs (WJ-MSCs). Both groups will receive standard of care treatment for COVID (e.g. dexamethasone)
- Trial name
- ProTrans19+ (NCT04869397)
- Testing
- Allogeneic Wharton's jelly-MSCs (WJ-MSC)
- Where
- Canada
- Volunteers
- 19 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Telomere Biology Disorders, Dyskeratosis Congenita
Nucleoside Therapy in Patients With Telomere Biology Disorders
The goal of this clinical trial is to learn if a combination therapy of deoxycytidine (dC) plus deoxythymidine (dT) is safe in patients with telomere biology disorders.
- Conditions
- Telomere Biology Disorders, Dyskeratosis Congenita, Revesz Syndrome, Hoyeraal Hreidarsson Syndrome
- Trial name
- NCT06817590
- Testing
- deoxycytidine, deoxythymidine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Suneet Agarwal
Arthritis, Rheumatoid, Spondylitis
Biologic National Registry
BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists
- Trial name
- BINAR (NCT03793660)
- Where
- 10 sites in Tunisia
- Volunteers
- 439 people
- Sponsor
- Dacima Consulting
Atherosclerosis
ELITE: Early Versus Late Intervention Trial With Estradiol
The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy postmenopausal women.
- Trial name
- NCT00114517
- Testing
- 17B-estradiol
- Where
- United States
- Volunteers
- 643 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Venous Ulcers
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.
- Trial name
- NCT00207818
- Testing
- self assembled skin substitute (SASS)
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- CHU de Quebec-Universite Laval
Asthma, Asthma; Eosinophilic
Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients
Real-life, observational, retrospective, multicenter study to evaluate the effects of anti-IL5 biological treatments on blood total IgE Levels in atopic patients with severe eosinophilic asthma.
- Trial name
- BIONIGE (NCT04181190)
- Testing
- Total IgE, Blood cell counts, Asthma control assessment
- Where
- 8 sites in Italy
- Volunteers
- 130 people
- Sponsor
- Università degli Studi di Ferrara
Rheumatoid Arthritis
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different…
- Trial name
- ROC (NCT01000441)
- Testing
- infliximab, etanercept, adalimumab, abatacept, rituximab or tocilizumab
- Where
- 44 sites in France, Monaco
- Volunteers
- 300 people
- Sponsor
- University Hospital, Strasbourg, France
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
International Severe CRSwNP Registry 2024-2028
The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more…
- Trial name
- INVENT (NCT06617754)
- Testing
- Biologic drugs
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Vibeke Backer
Asthma, Allergic
Biologics and Sublingual Immunotherapy
Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis.
- Trial name
- BSIPL (NCT06027073)
- Testing
- omalizumab
- Volunteers
- 150 people
- Sponsor
- Medical University of Silesia
Glioma
BIO-SHORT: Hypofractionated RT for Poor-Prognosis GBM
High grade gliomas, particularly glioblastoma, are among the most aggressive brain tumors and are associated with poor outcomes despite standard treatment.
- Trial name
- BIO-SHORT (NCT07338539)
- Testing
- Standard radiotherapy using hypofractionated RT, Experimental Arm Intervention
- Where
- India
- Volunteers
- 108 people
- Sponsor
- Tata Memorial Centre
HIV Infections
Immunogenicity and Safety Trial of the HIV-1 Tat Vaccine
The study is a randomized, open label, phase II clinical trial directed at evaluating the immunogenicity (as a primary end-point) and the safety (as a secondary end-point), of the recombinant HIV-1 Tat vaccine in HIV-1 infected…
- Trial name
- ISS T-002 (NCT00751595)
- Testing
- Tat protein
- Where
- 11 sites in Italy
- Volunteers
- 168 people
- Sponsor
- Barbara Ensoli, MD
Chronic Plaque Psoriasis
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.
- Trial name
- VIP-S (NCT02690701)
- Testing
- Secukinumab 300 mg
- Where
- 12 sites in United States
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
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