Clinical trials: Biotherapy
Leukemia, Hairy Cell
Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia
Background: Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells.
- Trial name
- NCT01829711
- Testing
- Moxetumomab pasudotox, IV Bag Protectant for Moxetumomab pasudotox
- Where
- 34 sites in United States, Belgium and 12 more
- Volunteers
- 80 people
- Sponsor
- MedImmune LLC
Asthma
Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts
This study will utilize University of Michigan EMR data to form a retrospective cohort of severe asthma patients on biologic therapies for asthma with computed tomography (CT) imaging and known outcomes on therapy.
- Trial name
- NCT06922760
- Where
- 2 sites in United States
- Volunteers
- 233 people
- Sponsor
- University of Michigan
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy
This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic…
- Trial name
- TOSCA (NCT02001987)
- Testing
- Tocilizumab, Methotrexate, csDMARDs
- Where
- 32 sites in France
- Volunteers
- 139 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced…
- Trial name
- RADAR (NCT01162421)
- Testing
- adalimumab, Methotrexate
- Volunteers
- 77 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Rheumatologic Disorder, Inflammatory Bowel Diseases
Flu Vaccine Response in Patients on Biologic Therapies
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies.
- Conditions
- Rheumatologic Disorder, Inflammatory Bowel Diseases, Immune Complex Diseases
- Trial name
- NCT03277703
- Testing
- Influenza vaccine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stony Brook University
Allergic Rhinitis
A Novel Biologic Therapy for Perennial Allergic Rhinitis
This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept study which will evaluate the effect of a preparation of FDA approved allergens (PMA) used as a sub-cutaneously administered…
- Trial name
- NCT03360071
- Testing
- Allergen Immunotherapy Extract, Allergen Immunotherapy Control
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Johns Hopkins University
Melanoma (Skin)
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00006237
- Testing
- interleukin-2, filgrastim, interferon alfa
- Where
- 297 sites in United States, Australia
- Volunteers
- 432 people
- Sponsor
- SWOG Cancer Research Network
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
Crohn Disease
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's…
- Trial name
- NCT00094458
- Testing
- infliximab (IFX) infusion; azathioprine (AZA) caps
- Where
- 115 sites in United States, Austria and 13 more
- Volunteers
- 508 people
- Sponsor
- Centocor Ortho Biotech Services, L.L.C.
Breast Cancer
Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Women With Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation plus biological therapy may allow the doctor…
- Trial name
- NCT00020722
- Testing
- therapeutic autologous lymphocytes, Ifosfamide, carboplatin, and etoposide (ICE) regimen, Cyclophosphamide, Thiotepa, Carboplatin (CTC) or STAMP V (CTC)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Systemic Lupus Erythematosus
A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01597492
- Testing
- Belimumab plus Early Vaccination, Belimumab plus Late Vaccination
- Where
- 15 sites in United States
- Volunteers
- 79 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
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
Psoriasis
A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study.
- Trial name
- ESAQUALITY (NCT00687401)
- Testing
- Infliximab
- Volunteers
- 215 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Arthritis
An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy.
- Trial name
- NCT01543503
- Where
- 154 sites in Argentina, Belgium and 14 more
- Volunteers
- 1,225 people
- Sponsor
- Hoffmann-La Roche
Giant Cell Arteritis, Takayasu Arteritis
Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis
Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood.
- Conditions
- Giant Cell Arteritis, Takayasu Arteritis, Cogan Syndrome, Relapsing Polychondritis
- Trial name
- BIOVAS (NCT05168475)
- Testing
- Rituximab, Infliximab, Tocilizumab
- Where
- 5 sites in United Kingdom
- Volunteers
- 22 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
EBV-induced Lymphomas, EBV-associated Malignancies
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
- Conditions
- EBV-induced Lymphomas, EBV-associated Malignancies, Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
- Trial name
- NCT00002663
- Testing
- Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Atara Biotherapeutics
Ovarian Cancer, Fallopian Tube Cancer
Irinotecan and Bevacizumab for Recurrent Ovarian Cancer
The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in the treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when combined with bevacizumab.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Trial name
- NCT01091259
- Testing
- Irinotecan, Bevacizumab
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- NYU Langone Health
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Polyarticular Juvenile Rheumatoid Arthritis, Arthritis, Juvenile Idiopathic
Start Time Optimization of Biologics in Polyarticular JIA
STOP-JIA is a PCORI funded prospective observational study which compared the clinical effectiveness and impact on patient reported outcomes of 3 Childhood Arthritis \& Rheumatology Research Alliance (CARRA) consensus derived…
- Trial name
- STOP-JIA (NCT02593006)
- Where
- 55 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Hackensack Meridian Health
Melanoma
Safety and Efficacy of Combination HDI and Anti-CTLA4 for Recurrent Inoperable Stage III or Stage IV Melanoma
To determine the safety and efficacy of the combination of HDI and anti-CTLA-4 monoclonal antibody for patients with recurrent inoperable stage III or stage IV melanoma.
- Trial name
- NCT00610857
- Testing
- Anti-CTLA4 monoclonal antibody and HDI
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Ahmad Tarhini