Clinical trials: Biological Therapy
Breast Cancer
Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer.
- Trial name
- NCT00656669
- Testing
- sunitinib alone, sunitinib plus paclitaxel, doxorubicin and cyclophosphamide
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Indiana University
Spondyloarthritis
Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy
Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs.
- Trial name
- MEDIBIOTE 3 (NCT04899154)
- Testing
- stool sampling
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hôpital Européen Marseille
Psoriasis, Inflammation
Subclinical Impairment of Cardiovascular System in Patients With Psoriasis
A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, treated with five different types of antipsoriatic treatment, and 20 healthy patients.
- Conditions
- Psoriasis, Inflammation, Endothelial Dysfunction, Metabolic Disturbance
- Trial name
- PaS (NCT05957120)
- Where
- Slovenia
- Volunteers
- 100 people
- Sponsor
- University Medical Centre Ljubljana
Breast Cancer
Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer
This is a pilot "window of opportunity" clinical study in patients with operable breast cancer investigating use of reparixin as single agent in the time period between clinical diagnosis and surgery.
- Trial name
- NCT01861054
- Testing
- Reparixin
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dompé Farmaceutici S.p.A
Psoriasis
Exploration of the Cellular and Molecular Mechanisms in Patients Receiving Biotherapies Targeting the IL-23/IL-17 Axis in Cutaneous Psoriasis
This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a monocentric, non randomized prospective study aiming to better understand the mechanisms of the response to…
- Trial name
- Pso23 (NCT05111210)
- Testing
- Blood sample, Data collection, skin biopsies
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Institut Pasteur
Psoriasis
Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy
This study will evaluate the ability of the vaccine to produce antibodies against herpes zoster virus (shingles) and safety of vaccination with Varicella Zoster Vaccine in patients with moderate to severe psoriasis who will…
- Trial name
- NCT02408159
- Testing
- Varicella Zoster Vaccine
- Where
- 3 sites in Canada
- Volunteers
- 3 people
- Sponsor
- Innovaderm Research Inc.
Asthma, Immunogenicity
Real-world Immunogenicity of Anti-IL5/5a Antibody
This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety.
- Conditions
- Asthma, Immunogenicity, Biologics
- Trial name
- NCT07567690
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Samsung Medical Center
Head and Neck Cancer, Parotid Gland Cancer
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
- Conditions
- Head and Neck Cancer, Parotid Gland Cancer, Thyroid Gland Cancer, Melanoma
- Trial name
- NCT00405405
- Testing
- Cisplatin, Docetaxel, Bevacizumab
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Hemorrhagic Shock
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
Overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield, in civilian life, or which can be used during initial resuscitation in the first fixed facility…
- Trial name
- NCT01239680
- Testing
- Glutamine, Ringer's Lactate
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- University of Missouri, Kansas City
Autoimmune Rheumatic Diseases, Prevention
Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases
This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving…
- Trial name
- TB-RESCREEN (NCT07731672)
- Testing
- re-screening, No Rescreening
- Where
- Brazil
- Volunteers
- 1,660 people
- Sponsor
- University of Sao Paulo General Hospital
Ulcerative Colitis (UC), Fecal Calprotetin
Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at Week 2 and Week 4 after initiating biologic therapy (vedolizumab or infliximab) can…
- Conditions
- Ulcerative Colitis (UC), Fecal Calprotetin, FIT
- Trial name
- FORESEE-UC (NCT07111572)
- Testing
- fecal calprotectin
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Qilu Hospital of Shandong University
Prostate Cancer
Early Prostate Cancer: Predicting Treatment Response
This study will replicate/validate the risk prediction model developed for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient population to assess generalizability of the…
- Trial name
- NCT03770351
- Where
- 5 sites in United States
- Volunteers
- 693 people
- Sponsor
- University of California, Irvine
Breast Cancer
Biological Therapy in Treating Women With Metastatic Breast Cancer
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
- Trial name
- NCT00002780
- Testing
- aldesleukin, cytokine therapy, sargramostim
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- St. Luke's Medical Center
Rheumatoid Arthritis
Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment
A potential application of therapeutic drug monitoring is to predict efficacy after switch to another biological in the case of inefficacy of the previous TNF-inhibitor (TNFi) in rheumatoid arthritis (RA) patients.
- Trial name
- ADDORA-switch (NCT04251741)
- Testing
- Adalimumab trough concentration, Usual care
- Where
- 2 sites in Netherlands
- Volunteers
- 86 people
- Sponsor
- Reade Rheumatology Research Institute
Neuroblastoma
Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma
Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual incidence of 10.5 per million children less than 15 years of age. NB accounts for 15% of childhood cancer deaths.
- Trial name
- NCT01404702
- Testing
- Zoledronic Acid, Aldesleukin
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Alabama at Birmingham
Inflammatory Bowel Disease (IBD), Ulcerative Colitis
A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)
This is a non-interventional, retrospective study of adult participants with IBD. IBD consists of either ulcerative colitis (UC) or Crohn's disease (CD).
- Conditions
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's Disease
- Trial name
- NCT05596422
- Where
- 4 sites in Taiwan
- Volunteers
- 423 people
- Sponsor
- Takeda
Cystic Fibrosis
A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function
This is a prospective, multi-center observational study. The study is designed to measure the clinical effectiveness of elexacaftor, tezacaftor and ivacaftor (ETI) triple combination therapy in people with one or more copies of…
- Trial name
- PROMISE (NCT04038047)
- Where
- 56 sites in United States
- Volunteers
- 490 people
- Sponsor
- Nicole Hamblett
Chronic Arthritis
Biomarkers in Chronic Arthritis
Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.
- Trial name
- NCT02909998
- Testing
- Blood sample
- Volunteers
- 379 people
- Sponsor
- University Hospital, Montpellier
Psoriasis
Psoriasis Longitudinal Assessment and Registry
The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis.
- Trial name
- PSOLAR (NCT00508547)
- Where
- 320 sites in United States, Argentina and 20 more
- Volunteers
- 21,190 people
- Sponsor
- Janssen Scientific Affairs, LLC
Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia
Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot studies have shown that treatment with Azacitidine can induce transfusion independency in previous transfusion dependent patients with…
- Trial name
- NCT01048034
- Testing
- Azacitidine, Erythropoetin
- Where
- 17 sites in Denmark, Norway and 1 more
- Volunteers
- 30 people
- Sponsor
- Nordic MDS Group
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