RoActemra 162 mg solution for injection in pre-filled syringe.
Sponsors
Dr. Reddy's Laboratories Limited, Abbvie Deutschland GmbH & Co. KG, Centre Hospitalier Universitaire De Dijon, Vaestra Goetalandsregionen, Assistance Publique Hopitaux De Paris
Conditions
Acute Anterior Ischemic Optic Neuropathy associated with Giant Cell Arteritis in Horton's DiseaseAdult patients of either gender with active moderate to severe rheumatoid arthritis (1987 revised ACR criteria; Arnett et al. 1987) of at least 6 months durationAdults patients suffering from rheumatoid arthritis and in adequate response to one or two targeted treatments.Chronic active antibody-mediated rejection in kidney transplant recipientsGIant cell ArteritisGiant Cell ArteritisKidney transplantationRheumatoid Arthritis
Phase 1
Phase 2
UVB : Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Adalimumab to that of Tocilizumab in severe uveitis of Behçet’s disease
RecruitingCTIS2024-513371-41-00
Start: 2024-04-25Target: 60Updated: 2025-07-11
French prospective open label phase II randomized non-comparative study of SC tocilizumab associated with IV pulse steroid versus IV pulse steroid alone for the treatment of acute anterior ischemic optic neuropathy associated with giant cell arteritis. (TOCIAION)
Not yet recruitingCTIS2024-519977-20-00
Target: 58Updated: 2025-01-27
Phase 3
TocilizuMab discontinuAtion in GIant Cell Arteritis
Active, not recruitingCTIS2023-505515-21-00
Start: 2024-04-02Target: 120Updated: 2025-11-07
A phase III, randomised, double-blind, multicentre study comparing the efficacy, safety, and immunogenicity of proposed tocilizumab biosimilar (DRL_Tocilizumab) with tocilizumab reference product (RoActemra®) administered by the subcutaneous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis
WithdrawnCTIS2022-501361-44-00
Target: 357Updated: 2023-10-09
A multicenter, randomized open-label study to assess the efficacy, safety, and pharmacokinetics of upadacitinib with a tocilizumab reference arm in subjects from 1 year to less than 18 years old with active systemic juvenile idiopathic arthritis.
RecruitingCTIS2022-501599-25-00
Start: 2024-03-19Target: 33Updated: 2025-11-24
A randomized controlled open-label multicenter study to assess the efficacy of TCZ in treatment of late/chronic active antibody-mediated rejection in kidney transplant recipients
RecruitingCTIS2024-510615-29-00
Start: 2021-05-24Target: 50Updated: 2025-12-03
MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial
Active, not recruitingCTIS2024-512269-14-00
Start: 2020-01-27Target: 230Updated: 2025-11-21
A multicentre clinical trial evaluating the safety and efficacy of the combination of nintedanib and tocilizumab compared to standard treatment in patients with systemic sclerosis and interstitial lung disease. Analysis with theranostic approach and assessment of cytokine activity, markers of inflammation and pulmonary fibrosis using computed tomography, positron emission tomography, and metabolome and transcriptome studies in selected patients. NINTOC-TU study
RecruitingCTIS2024-517005-85-00
Start: 2025-07-01Target: 86Updated: 2024-10-16
Phase 4
ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TARGETED TREATMENT INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPENLABELED, SUPERIORITY TRIAL. -SUNSTAR-
Active, not recruitingCTIS2024-515600-39-00
Start: 2018-01-23Target: 224Updated: 2024-07-31
A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.
Not yet recruitingCTIS2024-516723-14-00
Target: 705Updated: 2024-12-30
Filling bone erosions: a longitudinal multicentric HR-pQCT study of subcutaneous tocilizumab in rheumatoid arthritis
Active, not recruitingCTIS2024-517686-17-01
Start: 2016-06-30Target: 60Updated: 2025-01-02