Clinical trials: Tocilizumab
Healthy Volunteer
A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers
The study consists of an eligibility screening period, two study periods involving single doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover design with an interval of 6 weeks between periods…
- Trial name
- NCT02678988
- Testing
- AI-1000 G2, PFS-NSD, Tocilizumab
- Where
- 3 sites in United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Fibrous Dysplasia of Bone
TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately.
- Trial name
- TOCIDYS (NCT01791842)
- Testing
- Tocilizumab
- Where
- 3 sites in France
- Volunteers
- 19 people
- Sponsor
- Hospices Civils de Lyon
Rheumatoid Arthritis
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in…
- Trial name
- NCT02046616
- Testing
- Tocilizumab, Methotrexate, Non-Biologic DMARDs
- Where
- 27 sites in Denmark, Finland and 2 more
- Volunteers
- 133 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate…
- Trial name
- NCT01564901
- Where
- 13 sites in Spain
- Volunteers
- 23 people
- Sponsor
- Hoffmann-La Roche
Giant Cell Arteritis
Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.
Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been found to have a crucial role in the pathogenesis of Giant cel arteritis (GCA).
- Trial name
- NCT03244709
- Testing
- Tocilizumab
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Hospital of Prato
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
Pneumonia
Randomised Evaluation of COVID-19 Therapy
RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin…
- Trial name
- RECOVERY (NCT04381936)
- Testing
- Lopinavir-Ritonavir, Corticosteroid, Hydroxychloroquine
- Where
- 16 sites in Belgium, Estonia and 14 more
- Volunteers
- 70,000 people
- Sponsor
- University of Oxford
Rheumatoid Arthritis
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and…
- Trial name
- NCT01044498
- Testing
- Tocilizumab, Ortho-Novum® 1/35
- Where
- 6 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Refractory Acute Myeloid Leukemia, Refractory Acute Lymphoblastic Leukemia
Personalized Targeted Preparative Regimen Before T-depleted Allogeneic HSCT in Children With Chemoresistent Acute Leukemias
The purpose of this study is to evaluate the safety and efficiency of personalized targeted therapy in combination with high-dose chemotherapy as part of a preparative regimen before T-depleted allogeneic hematopoietic stem cell…
- Trial name
- NCT04000698
- Testing
- Preparative regimen
- Where
- Russia
- Volunteers
- 25 people
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Juvenile Idiopathic Arthritis
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study.
- Trial name
- NCT01673919
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 4 sites in France
- Volunteers
- 7 people
- Sponsor
- Hoffmann-La Roche
Healthy Men
A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects
This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.
- Trial name
- NCT05968508
- Testing
- BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Bio-Thera Solutions
Covid19, Urine
Risk Stratification of COVID-19 Using Urine Biomarkers
Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and in infected patients, it produces symptoms which range from completely asymptomatic to those expressing severe…
- Conditions
- Covid19, Urine, Biomarker, Acute Respiratory Failure With Hypoxia
- Trial name
- NCT04681040
- Where
- 7 sites in United States, Brazil and 3 more
- Volunteers
- 964 people
- Sponsor
- National Center for Global Health and Medicine, Japan
Glucocorticosteroid Refractory Acute GVHD
Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT)
The purpose of this study is to determine if Tocilizumab is a safe and effective treatment for steroid-refractory acute graft versus host disease.
- Trial name
- NCT01757197
- Testing
- Toclizumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Weill Medical College of Cornell University
Rheumatoid Arthritis
ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis
This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a…
- Trial name
- NCT01791205
- Where
- 28 sites in Italy
- Volunteers
- 304 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.
- Trial name
- NCT05489224
- Testing
- CT-P47, EU-approved RoActemra
- Where
- Poland
- Volunteers
- 471 people
- Sponsor
- Celltrion
Sars-CoV2
Tocilizumab Treatment in Patients With COVID-19
A phase II clinical trial will be carried out with the objective of studying the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical…
- Trial name
- NCT04363853
- Testing
- Tocilizumab 20 MG/ML
- Where
- Mexico
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
COVID-19, Outcome, Fatal
Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr.
- Conditions
- COVID-19, Outcome, Fatal, Tocilizumab, Interleukin 6
- Trial name
- CasiTocCOVID (NCT06233357)
- Testing
- treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
- Where
- Germany
- Volunteers
- 95 people
- Sponsor
- University of Ulm
Rheumatoid Arthritis
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different…
- Trial name
- ROC (NCT01000441)
- Testing
- infliximab, etanercept, adalimumab, abatacept, rituximab or tocilizumab
- Where
- 44 sites in France, Monaco
- Volunteers
- 300 people
- Sponsor
- University Hospital, Strasbourg, France
COVID-19
Methodologies for Observational Studies Comparing Inpatient COVID-19 Treatments
To apply and compare two different methodological approaches (one applying diagnostics steps and contingencies and the other not) to the illustrative example described below: Illustrative Example - Objective I aims to…
- Trial name
- NCT05638932
- Testing
- Initiation of IL6Ri (tocilizumab or sarilumab) versus JAKi (baricitinib or tofacitinib) added to systemic corticosteroids of interest (CSI)
- Where
- United States
- Volunteers
- 1,442 people
- Sponsor
- Aetion, Inc.
Mature B-Cell Non-Hodgkin Lymphoma
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric…
- Trial name
- iMATRIX GLO (NCT05533775)
- Testing
- Obinutuzumab, Glofitamab, Rituximab
- Where
- 30 sites in United States, Australia and 11 more
- Volunteers
- 65 people
- Sponsor
- Hoffmann-La Roche