Clinical trials: Response Evaluation
Rheumatoid Arthritis
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or…
- Trial name
- NCT01149057
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 16 sites in Israel
- Volunteers
- 145 people
- Sponsor
- Hoffmann-La Roche
Cytokine Release Syndrome, COVID19
Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS
This protocol will evaluate the efficacy of Therapeutic Plasma Exchange (TPE) alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome (CRS).
- Trial name
- NCT04374149
- Testing
- Therapeutic Plasma Exchange, Ruxolitinib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Prisma Health-Upstate
Neurotoxicity, Pain
Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain, numbness, tingling, and other symptoms of peripheral neuropathy.
- Conditions
- Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Trial name
- NCT00471445
- Testing
- ketamine/amitriptyline NP-H cream
- Where
- 17 sites in United States
- Volunteers
- 462 people
- Sponsor
- Gary Morrow
Contraception
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study
The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in…
- Trial name
- NCT02817841
- Testing
- 15 mg E4/3 mg DRSP
- Where
- 2 sites in United States, Canada
- Volunteers
- 2,148 people, healthy volunteers welcome
- Sponsor
- Estetra
Rheumatoid Arthritis
A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.
This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rheumatoid arthritis who have…
- Trial name
- NCT01195272
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents.
- Trial name
- NCT00504777
- Testing
- rituximab [MabThera/Rituxan], Methotrexate
- Where
- 10 sites in Taiwan
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment
The objective of this study was to verify the efficacy of ASP015K versus placebo administrated in combination with methotrexate (MTX) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an…
- Trial name
- NCT02305849
- Testing
- Peficitinib, Methotrexate
- Where
- 146 sites in Japan
- Volunteers
- 519 people
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers
EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks
EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics.
- Trial name
- NCT01349140
- Testing
- SKY0402
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
AKI
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin [SnPP]/iron sucrose [FeS]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
- Trial name
- START (NCT04564833)
- Testing
- Low Dose RBT-1, High Dose RBT-1
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 152 people
- Sponsor
- Renibus Therapeutics, Inc.
Melanoma, Renal Cell Carcinoma
Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma
This is a phase 2, Simon's 2-stage designed study with 2 cohorts of anti-PD-1/PD-L1 experienced patients with untreated brain metastases: 1) melanoma and 2) renal cell carcinoma (RCC).
- Conditions
- Melanoma, Renal Cell Carcinoma, Brain Metastases, PD1/PD-L1 Experienced
- Trial name
- NCT04955743
- Testing
- Pembrolizumab, Lenvatinib
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Yale University
AIDS, AIDS Vaccines
Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
The purpose of this study is to investigate a combined set of parameters deemed to impact the quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral therapy-naïve HIV-1 infected subjects.
- Trial name
- NCT01610427
- Testing
- Blood sample collection
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.
- Trial name
- NCT03760003
- Testing
- ABX464 100 mg, ABX464 50 mg, ABX464 25 mg
- Where
- 130 sites in United States, Austria and 15 more
- Volunteers
- 355 people
- Sponsor
- Abivax S.A.
Major Depressive Disorder, Recurrent
Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)
The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096) versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who are partial responders to antidepressant…
- Trial name
- NCT01554176
- Testing
- Filorexant
- Volunteers
- 129 people
- Sponsor
- Merck Sharp & Dohme LLC
Sepsis
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients
The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the…
- Trial name
- NCT01027897
- Testing
- Doripenem
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Emory University
Meningococcal Meningitis
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY…
- Trial name
- NCT00856297
- Testing
- MenACWY-CRM conjugate vaccine, Licensed comparator
- Where
- 32 sites in United States
- Volunteers
- 389 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Rheumatoid Arthritis (RA)
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function.
- Trial name
- NCT04888585
- Testing
- ABBV-154
- Where
- 220 sites in United States, Australia and 19 more
- Volunteers
- 473 people
- Sponsor
- AbbVie
Major Depressive Disorder
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
- Trial name
- NCT02085135
- Testing
- ALKS 5461
- Where
- 9 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Alkermes, Inc.
Influenza
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
- Trial name
- NCT00971425
- Testing
- Pandemrix (GSK investigational influenza GSK2340272A vaccine), Fluarix™
- Where
- 6 sites in Germany
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gastroparesis
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis.
- Trial name
- NCT04026997
- Testing
- CIN-102 Dose 1, CIN-102 Dose 2, CIN-102 Dose 3
- Where
- 19 sites in United States
- Volunteers
- 72 people
- Sponsor
- CinDome Pharma, Inc.
Breast Cancer
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial…
- Trial name
- NCT00885755
- Testing
- Standard taxane therapy, capecitabine [Xeloda], trastuzumab [Herceptin]
- Where
- 13 sites in Australia, Spain and 2 more
- Volunteers
- 33 people
- Sponsor
- Hoffmann-La Roche