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Clinical trials for Golimumab

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
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    • 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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    156 result(s) found for: Golimumab. Displaying page 1 of 8.
    1  2  3  4  5  6  7  8  Next»
    EudraCT Number: 2019-003987-37 Sponsor Protocol Number: 2019-001G Start Date*: 2020-02-26
    Sponsor Name:University Medical Centre Ljubljana, Department of gastroenterology
    Full Title: Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens
    Medical condition: Ulcerative colitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003314-39 Sponsor Protocol Number: 78934804CRD2001 Start Date*: 2023-02-21
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Gusel...
    Medical condition: Moderately to Severely Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) HU (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) AT (Ongoing) PT (Trial now transitioned) BG (Trial now transitioned) IE (Completed) NO (Trial now transitioned) SI (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) GR (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-005214-19 Sponsor Protocol Number: S127AMCGolimumabPsA Start Date*: 2013-06-20
    Sponsor Name:Academic Medical Center, Department of Rheumatology
    Full Title: A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis
    Medical condition: active psoriatic arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001510-15 Sponsor Protocol Number: CNTO1959UCO2002 Start Date*: 2019-05-02
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and G...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-005528-39 Sponsor Protocol Number: 78934804UCO2001 Start Date*: 2023-02-16
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Gusel...
    Medical condition: Moderately to Severely Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) HU (Ongoing) CZ (Trial now transitioned) NL (Trial now transitioned) SK (Trial now transitioned) AT (Trial now transitioned) BG (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) IT (Trial now transitioned) DK (Trial now transitioned) SE (Trial now transitioned) PT (Trial now transitioned) SI (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004020-65 Sponsor Protocol Number: MK-8259-038 Start Date*: 2017-07-20
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Cont...
    Medical condition: Treatment of non-radiographic axial spondyloarthritis (nr-axSpA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10076297 Non-radiographic axial spondyloarthritis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) ES (Completed) NL (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2012-002458-21 Sponsor Protocol Number: MK8259-012-00 Start Date*: 2012-07-23
    Sponsor Name:MERCK SHARP & DOHME B.V.
    Full Title: Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab
    Medical condition: Ankylosing Spondylitis (Bechterew disease)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10002557 Ankylosing spondylitis and other inflammatory spondylopathies LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000225-12 Sponsor Protocol Number: CNTO148DML1001 Start Date*: 2017-08-01
    Sponsor Name:Janssen Biologics BV
    Full Title: A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes
    Medical condition: A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2017-001374-42 Sponsor Protocol Number: 3573 Start Date*: 2017-07-21
    Sponsor Name:Guy's and St Thomas' NHS Foundation Trust
    Full Title: Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels
    Medical condition: Ulcerative Colitis (UC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2006-003398-28 Sponsor Protocol Number: C0524T17 Start Date*: 2007-11-15
    Sponsor Name:Centocor BV
    Full Title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderat...
    Medical condition: Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) AT (Completed) BE (Completed) FR (Completed) LT (Completed) LV (Completed) NL (Completed) DK (Completed) SE (Completed) BG (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2019-004101-27 Sponsor Protocol Number: INDIGO Start Date*: 2020-01-15
    Sponsor Name:Sint Maartenskliniek
    Full Title: INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’
    Medical condition: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10037160 Psoriatic arthritis LLT
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10071400 Axial spondyloarthritis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003262-25 Sponsor Protocol Number: MK8259-022 Start Date*: 2014-12-12
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003399-37 Sponsor Protocol Number: C0524T18 Start Date*: 2007-11-27
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderat...
    Medical condition: Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) AT (Completed) BE (Completed) FR (Completed) LT (Completed) LV (Prematurely Ended) NL (Completed) DK (Completed) SE (Completed) BG (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2006-003397-94 Sponsor Protocol Number: C0524T16 Start Date*: 2007-09-05
    Sponsor Name:Centocor BV
    Full Title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderate...
    Medical condition: Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) AT (Prematurely Ended) BE (Completed) FR (Completed) NL (Prematurely Ended) LT (Completed) LV (Prematurely Ended) SE (Prematurely Ended) SK (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004496-31 Sponsor Protocol Number: CNTO148UCO3003 Start Date*: 2018-11-07
    Sponsor Name:Janssen Biologics BV
    Full Title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Pa...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) ES (Ongoing) FR (Trial now transitioned) NL (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-004366-18 Sponsor Protocol Number: CNTO148UCO1001 Start Date*: 2013-07-30
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFα Antibody, in Pediatric Subjects with Moderately to Severely Active ...
    Medical condition: Ulcerative Colitis in pediatric subjects
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed) DE (Completed) NL (Ongoing) DK (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-002579-27 Sponsor Protocol Number: UC-GOL Start Date*: 2015-03-03
    Sponsor Name:Istituto Clinico Humanitas
    Full Title: Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis.
    Medical condition: active steroid-dependent ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000643-40 Sponsor Protocol Number: 50307 Start Date*: 2014-01-10
    Sponsor Name:Instituto de Medicina Molecular
    Full Title: A multicentre, randomized, double-blind, parallel–group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy, in improving dactylitis and enthesi...
    Medical condition: Psoriatic arthritis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000152-96 Sponsor Protocol Number: 2016-01 Start Date*: 2019-12-16
    Sponsor Name:GETAID
    Full Title: Intensive Treatment to Reach the target with Golimumab in ulcErative coliTis – In-TARGET
    Medical condition: Moderate to severe ulcerative colitis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-010582-23 Sponsor Protocol Number: CNTO148ART3002 Start Date*: 2010-01-04
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept ...
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) AT (Completed) SE (Completed) GR (Completed) IT (Completed) GB (Completed)
    Trial results: View results
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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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