Clinical trials: Biological Therapy
Esophageal Atresia
Individualized Management for Long Gap Esophageal Atresia
The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most challenging congenital malformations in neonatal surgery.
- Trial name
- NCT03023865
- Testing
- Staged stress function
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Rheumatoid Arthritis
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with…
- Trial name
- NCT02557100
- Testing
- Abatacept, Adalimumab, Methotrexate
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 80 people
- Sponsor
- Bristol-Myers Squibb
Rheumatoid Arthritis
National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)
Observational registry to assess the longer-term risk of serious infections and malignancies reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult Rheumatoid…
- Trial name
- NCT01095393
- Volunteers
- 12,500 people
- Sponsor
- UCB Pharma
Congestive Heart Failure, Ischemic Cardiomyopathy
AutoLogous Human CArdiac-Derived Stem Cell to Treat Ischemic cArdiomyopathy (ALCADIA)
The aim of this study is to evaluate the safety and efficacy on the transplantation of autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic fibroblast growth factor (bFGF) to severe refractory…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Ventricular Dysfunction
- Trial name
- ALCADIA (NCT00981006)
- Testing
- human cardiac stem cells
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Naofumi Takehara
Lymphoma
Biological Therapy Plus Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
- Trial name
- NCT00040950
- Testing
- rituximab, agatolimod sodium
- Where
- United States
- Sponsor
- Jonsson Comprehensive Cancer Center
Crohn Disease
Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy
INTRODUCTION: Vedolizumab is a gut selective anti-integrin agent which binds to the alfa4beta7 integrin, preventing its coupling to the endothelial MadCAM-1.
- Trial name
- NCT04362735
- Testing
- Vedolizumab
- Volunteers
- 100 people
- Sponsor
- Pontifícia Universidade Católica do Paraná
Chronic Kidney Disease, Anemia
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to…
- Trial name
- NCT00761657
- Testing
- Roxadustat
- Where
- 34 sites in United States
- Volunteers
- 117 people
- Sponsor
- Kyntra Bio
Ovary Neoplasm, Ovarian Cancer
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian…
- Conditions
- Ovary Neoplasm, Ovarian Cancer, Epithelial Ovarian Cancer, Recurrent
- Trial name
- NCT06305299
- Testing
- iC9-CAR.B7-H3 T cells, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Rheumatoid Arthritis
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American…
- Trial name
- FINCH 2 (NCT02873936)
- Testing
- Filgotinib, csDMARDs
- Where
- 104 sites in United States, Argentina and 13 more
- Volunteers
- 449 people
- Sponsor
- Gilead Sciences
Cancer
Prospective Clinical and Biologic Study of Secondary Cutaneous Effects in Targeted Cancer Therapies
The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in patients treated using targeted therapies in order to have a better understanding of the skin pathophysiology.
- Trial name
- SKINTARGET (NCT02517281)
- Testing
- Biopsy
- Where
- France
- Volunteers
- 141 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
MDS
Allo vs Hypomethylating/Best Supportive Care in MDS (BMTCTN1102)
This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant…
- Trial name
- NCT02016781
- Testing
- Allogeneic Hematopoietic Cell Transplant, Hypomethylating Therapy / Best Supportive Care
- Where
- 37 sites in United States
- Volunteers
- 384 people
- Sponsor
- Medical College of Wisconsin
Inflammatory Bowel Diseases, Crohn Disease
Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease
Prospective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab, ustekinumab and tofacitinib will be made…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Trial name
- BioIBD (NCT03885713)
- Testing
- Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib
- Where
- 21 sites in Spain
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Psoriasis
A Priming Intervention to Increase Patient Willingness to Use Injectables for the Management of Psoriasis
Biologic medications have revolutionized the treatment of inflammatory diseases such as moderate-to-severe psoriasis. Though very effective with an excellent safety profile, patients may be apprehensive about choosing a biologic…
- Trial name
- NCT03465696
- Testing
- Group #2 (Intervention), Group #3 (Intervention)
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Wake Forest University Health Sciences
Rheumatoid Arthritis
An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy
This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.
- Trial name
- NCT01664117
- Where
- 41 sites in Spain
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
Supporting Patient Care With Electronic Resources in the United States
This proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US patients with rheumatoid arthritis.
- Trial name
- SuPER-US (NCT02787538)
- Testing
- US-ANSWER-2 decision aid, Control group (Online medication guide)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Massachusetts General Hospital
Multiple Sclerosis, Fatigue
High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue
Fatigue is one of the most frequently reported and disabling impairments in multiple sclerosis (MS) and is associated with activity limitations, participation restrictions and reduced health-related quality of life (HRQL).MS…
- Conditions
- Multiple Sclerosis, Fatigue, Exercise Therapy, Resistance Training
- Trial name
- NCT04562376
- Testing
- High-intensity resistance training, Low frequency of high-intensity resistance training
- Where
- Sweden
- Volunteers
- 73 people
- Sponsor
- Karolinska Institutet
Rheumatoid Arthritis
A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis
This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have…
- Trial name
- NCT01866150
- Where
- 15 sites in United Kingdom
- Volunteers
- 476 people
- Sponsor
- Hoffmann-La Roche
Advanced Cancers
Rational Therapeutics Based on Matched Tumor and Normal Tissue
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more…
- Trial name
- NCT02272595
- Testing
- Treatment Based on Genetic Mutation, Treatment Based on No Genetic Mutation
- Where
- 4 sites in United States, France and 2 more
- Volunteers
- 3 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia
Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)
The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.
- Trial name
- NCT00266136
- Testing
- Cytarabine, Thioguanine, Daunorubicin
- Where
- Germany
- Volunteers
- 3,500 people
- Sponsor
- University Hospital Muenster
Hidradenitis Suppurativa
Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
The purpose of this study is to determine the effectiveness and safety of efalizumab in treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people who respond to treatment with efalizumab, after…
- Trial name
- NCT00134134
- Testing
- efalizumab
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- NYU Langone Health
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