Clinical trials: Biological Therapy
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
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
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
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
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
Plaque Psoriasis
Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis
To estimate the real-world effectiveness of approved biologics in subjects with moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.
- Trial name
- NCT02239666
- Testing
- NIS
- Where
- 106 sites in United States, France and 3 more
- Volunteers
- 899 people
- Sponsor
- AstraZeneca
Psoriasis
A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate
This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy.
- Trial name
- TRANSIT (NCT01059773)
- Testing
- Ustekinumab, Methotrexate
- Where
- 76 sites in Austria, Belgium and 17 more
- Volunteers
- 490 people
- Sponsor
- Janssen-Cilag International NV
Ovarian Cancer, Colorectal Cancer
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide
This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small…
- Conditions
- Ovarian Cancer, Colorectal Cancer, Carcinoma, Non-small-cell Lung, Prostate Cancer
- Trial name
- NCT00132522
- Testing
- EMD 273066
- Where
- 5 sites in United States, Switzerland
- Volunteers
- 45 people
- Sponsor
- EMD Serono
Rectal Cancer
TNFerade™ Plus Chemo/Radiation/Surgery for Rectal Cancer
The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed…
- Trial name
- NCT00137878
- Testing
- TNFerade™
- Where
- United States
- Sponsor
- GenVec
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
Malignant Melanoma, Neoplasm Metastasis
Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma
This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patient's immune system kill melanoma cells.
- Trial name
- NCT00116363
- Testing
- investigational drug INGN 241
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Introgen Therapeutics
Rheumatoid Arthritis
A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis
This non-interventional, retrospective, cross sectional chart review study will evaluate the management of rheumatoid arthritis patients with a biologic in monotherapy.
- Trial name
- NCT01640548
- Where
- 26 sites in United Kingdom
- Volunteers
- 320 people
- Sponsor
- Hoffmann-La Roche
Epithelial Ovarian Cancer, Fallopian Tube Cancer
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- OVATION 2 (NCT03393884)
- Testing
- IMNN-001, Carboplatin, Paclitaxel
- Where
- 21 sites in United States, Canada
- Volunteers
- 130 people
- Sponsor
- Imunon
Kidney Cancer
Vaccine Therapy in Treating Patients With Kidney Cancer
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells.
- Trial name
- NCT00014131
- Testing
- Biological/Vaccine: therapeutic autologous dendritic cells.
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Lisata Therapeutics, Inc.
Renal Cell Carcinoma
Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment
Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.
- Trial name
- NCT00678119
- Testing
- AGS-003, Sunitinib
- Where
- 14 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Argos Therapeutics
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active…
- Trial name
- ACT-MOVE (NCT02046603)
- Testing
- Tocilizumab, DMARDs, Oral Corticosteroids
- Where
- 38 sites in United Kingdom
- Volunteers
- 162 people
- Sponsor
- Hoffmann-La Roche
Prostate Cancer
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.
- Trial name
- NCT00065442
- Testing
- Sipuleucel-T
- Where
- 71 sites in United States, Canada
- Volunteers
- 512 people
- Sponsor
- Dendreon
Rectal Cancer
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer
Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients. 1.
- Trial name
- CEA+RC-BCG (NCT02403505)
- Testing
- CEA protein antigen plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Rheumatoid Arthritis
An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological…
- Trial name
- NCT00883753
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 171 sites in Australia, Canada and 12 more
- Volunteers
- 934 people
- Sponsor
- Hoffmann-La Roche
Crohn's Disease
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
- Trial name
- NCT03345836
- Testing
- Upadacitinib
- Where
- 428 sites in United States, Argentina and 46 more
- Volunteers
- 624 people
- Sponsor
- AbbVie