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RoActemra 162 mg solution for injection in pre-filled syringe.

DRUG12 trials

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

Phase 3

TocilizuMab discontinuAtion in GIant Cell Arteritis
Active, not recruitingCTIS2023-505515-21-00
Centre Hospitalier Universitaire De DijonGiant Cell Arteritis
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
Dr. Reddy's Laboratories LimitedAdult patients of either gender with active moderate to severe rheumatoid arthritis (1987 revised ACR criteria; Arnett et al. 1987) of at least 6 months duration, with an inadequate response to cDMARDs and currently on treatment with stable doses of MTX for at least 8 weeks prior to randomisation will be eligible for the study. Up to 25% of patients might have also been previously exposed to bDMARDs. Patients with previous exposure to other cDMARD and bDMARD would enter the study after an adequate washout period. Patients previously exposed to JAK pathway inhibitors will not be allowed in the study.
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
Abbvie Deutschland GmbH & Co. KGjuvenile idiopathic arthritis
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
Vaestra GoetalandsregionenChronic active antibody-mediated rejection in kidney transplant recipients
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
Centre Hospitalier Universitaire De DijonGIant cell Arteritis
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
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reichersystemic sclerosis with interstitial lung disease (ILD) in the course of the disease
Start: 2025-07-01Target: 86Updated: 2024-10-16

Phase 4