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Clinical trials for GP2017

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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    4 result(s) found for: GP2017. Displaying page 1 of 1.
    EudraCT Number: 2017-000679-10 Sponsor Protocol Number: CAIN457K2340 Start Date*: 2017-11-16
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to as...
    Medical condition: Ankylosing spondylitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10002556 Ankylosing spondylitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) FR (Completed) CZ (Completed) SK (Completed) FI (Completed) DK (Completed) NL (Completed) PT (Completed) PL (Completed) GR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-003433-10 Sponsor Protocol Number: GP17-302 Start Date*: 2016-06-08
    Sponsor Name:Hexal, AG
    Full Title: GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate t...
    Medical condition: rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) DE (Completed) HU (Completed) RO (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000747-11 Sponsor Protocol Number: GP17-301 Start Date*: 2013-11-25
    Sponsor Name:Hexal AG
    Full Title: A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and Humira® in patients with moderate t...
    Medical condition: Moderate to severe chronic plaque-type psoriasis
    Disease: Version SOC Term Classification Code Term Level
    17.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003882-32 Sponsor Protocol Number: CAIN457HDE01 Start Date*: 2019-05-08
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A randomized, open label multicenter trial to investigate the efficacy of a treat-to-target treatment strategy with secukinumab (AIN457) as a first-line biologic compared to a standard-of-care trea...
    Medical condition: Active axial spondyloarthritis (axSpA)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10071400 Axial spondyloarthritis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10076297 Non-radiographic axial spondyloarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
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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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