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Clinical trials for ABP 501

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 ).  
     
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    4 result(s) found for: ABP 501. Displaying page 1 of 1.
    EudraCT Number: 2013-004654-13 Sponsor Protocol Number: 20130258 Start Date*: 2014-02-12
    Sponsor Name:Amgen Inc.
    Full Title: An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis
    Medical condition: Moderate to Severe Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) GB (Completed) ES (Completed) DE (Completed) BG (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-000537-12 Sponsor Protocol Number: 20120263 Start Date*: 2013-09-25
    Sponsor Name:Amgen Inc
    Full Title: A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis
    Medical condition: Moderate to Severe Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-000525-31 Sponsor Protocol Number: 20120262 Start Date*: 2013-08-27
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
    Medical condition: Moderate to Severe Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    16.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) ES (Completed) DE (Completed) HU (Completed) PL (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-000542-18 Sponsor Protocol Number: 20200497 Start Date*: 2021-12-21
    Sponsor Name:Amgen Inc.
    Full Title: A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (adalimumab [US]) and ABP 501 Compared With ...
    Medical condition: Moderate to Severe Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed)
    Trial results: View results
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    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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