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Clinical trials for SAIT101

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44379   clinical trials with a EudraCT protocol, of which   7391   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    3 result(s) found for: SAIT101. Displaying page 1 of 1.
    EudraCT Number: 2016-001966-27 Sponsor Protocol Number: AGB002 Start Date*: 2016-09-07
    Sponsor Name:Archigen Biotech Limited
    Full Title: A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients w...
    Medical condition: Low Tumor Burden Follicular Lymphoma (LTBFL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) GB (Completed) CZ (Completed) BG (Completed) FR (Completed) LV (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2014-005368-13 Sponsor Protocol Number: AGB001 Start Date*: 2016-11-22
    Sponsor Name:Archigen Biotech Limited
    Full Title: A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rh...
    Medical condition: Severe Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10039075 Rheumatoid arthritis and associated conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) CZ (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004171-36 Sponsor Protocol Number: S101-RGL-003 Start Date*: 2012-03-30
    Sponsor Name:Samsung Electronics Co. Ltd.
    Full Title: A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthr...
    Medical condition: Severe Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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