Clinical trials: Biological Therapy
PRD (Paediatric Rheumatological Disease), IBD (Inflammatory Bowel Disease)
HPV Vaccination in Special Risk Groups: 5 Year Follow-up
In 2007-2009 the investigators conducted a study to determine the immunogenicity response to HPV vaccine in special risk patients known to be at increased risk of abnormal cervical cytology.
- Trial name
- NCT01896986
- Where
- Australia
- Volunteers
- 37 people
- Sponsor
- Murdoch Childrens Research Institute
Rheumatoid Arthritis
An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.
This observational study will describe the treatment patterns of usage of biological DMARDs in routine clinical practice and the demographics and RA disease characteristics in patients suffering from rheumatoid arthritis.
- Trial name
- NCT02590562
- Testing
- Routine clinical practice
- Where
- 15 sites in China
- Volunteers
- 808 people
- Sponsor
- Hoffmann-La Roche
Cutaneous Melanoma, Melanoma
A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma
This phase II trial studies the effect of a vaccine called CDX-1401 given with or without a biologic drug called CDX-301 in treating patients with stage IIB-IV melanoma.
- Conditions
- Cutaneous Melanoma, Melanoma, Melanoma of Unknown Primary, Mucosal Melanoma
- Trial name
- NCT02129075
- Testing
- DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Recombinant Flt3 Ligand
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- National Cancer Institute (NCI)
Moderate to Severe Rheumatoid Arthritis
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.
- Trial name
- ROCkIES (NCT01927757)
- Testing
- Etanercept, Methotrexate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 90 people
- Sponsor
- Amgen
Psoriatic Arthritis (PsA)
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
- Trial name
- KEEPsAKE2 (NCT03671148)
- Testing
- Risankizumab
- Where
- 138 sites in United States, Argentina and 23 more
- Volunteers
- 444 people
- Sponsor
- AbbVie
Asthma, Aspirin-Induced, Chronic Rhinosinusitis With Nasal Polyps
Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
Primary objective: to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score.
- Trial name
- AirGOs-biol (NCT04823585)
- Testing
- Mepolizumab
- Where
- Finland
- Volunteers
- 95 people
- Sponsor
- Helsinki University Central Hospital
Alzheimer Disease
Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease
The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
- Trial name
- PEGASUS (NCT03533257)
- Testing
- AMX0035
- Where
- 11 sites in United States
- Volunteers
- 95 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Crohn's Disease, Ulcerative Colitis
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor…
- Trial name
- COMPARE (NCT04852666)
- Where
- 2 sites in United States
- Volunteers
- 465 people
- Sponsor
- University of North Carolina, Chapel Hill
Depression
Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment
This study will use pre-treatment positron emission topography and functional magnetic resonance imaging scans of the brain to predict the most effective antidepressant treatment for people with major depressive disorder.
- Trial name
- NCT00456014
- Testing
- Escitalopram, Desipramine
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- New York State Psychiatric Institute
Breast Cancer, Estrogen Receptor-positive Breast Cancer
Biology Guided Therapy for Breast Cancer for ER Positive
There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor.
- Conditions
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- SPOCK (NCT04965688)
- Testing
- Biopsy-Guided Therapy Selection
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Inova Health Care Services
Carcinoma, Non-Small-Cell Lung
Carboplatin and Gemcitabine With Bevacizumab Every 2 Weeks for Stage IIIb/IV Non-small Cell Lung Cancer
The purpose of this study is to determine whether treatment with carboplatin and gemcitabine combined with bevacizumab every two weeks will provide increased survival.
- Trial name
- NCT00400803
- Testing
- Gemcitabine, Carboplatin, Bevacizumab
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Multiple Myeloma and Plasma Cell Neoplasm
Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and…
- Trial name
- NCT00004088
- Testing
- filgrastim, recombinant interferon alfa, busulfan
- Where
- 2 sites in United States
- Volunteers
- 77 people
- Sponsor
- City of Hope Medical Center
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Healthy Volunteers
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine…
- Trial name
- NCT01177293
- Testing
- Amlodipine - reference, Amlodipine ODT - test
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteers
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine…
- Trial name
- NCT01138826
- Testing
- Amlodipine - reference, Amlodipine ODT - test
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pityriasis Rubra Pilaris
A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris
The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris.
- Trial name
- NCT00815633
- Testing
- Alefacept
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Joshua Zeichner
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
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
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
HIV, HIV-associated Neurocognitive Disorder
Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen
In this study investigators will use a multi-modal imaging approach of MRS and fMRI to comprehensively assess the biological changes in the brain associated with EFV-based regimen (EFV/FTC/TDF), specifically alterations in the…
- Conditions
- HIV, HIV-associated Neurocognitive Disorder, Neurotoxicity
- Trial name
- NCT01978743
- Testing
- Raltegravir
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital