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Clinical trials for Biologic therapy

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   44340   clinical trials with a EudraCT protocol, of which   7370   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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    444 result(s) found for: Biologic therapy. Displaying page 1 of 23.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2013-000054-22 Sponsor Protocol Number: ML28641 Start Date*: 2013-10-01
    Sponsor Name:Roche Products Limited
    Full Title: OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOI...
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001240-35 Sponsor Protocol Number: M14-433 Start Date*: 2018-04-17
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who H...
    Medical condition: Crohn's Disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) SE (Completed) DE (Completed) AT (Completed) PT (Completed) BE (Completed) IE (Completed) GB (GB - no longer in EU/EEA) LV (Completed) HU (Completed) NL (Completed) PL (Completed) DK (Completed) LT (Completed) EE (Completed) ES (Completed) BG (Completed) HR (Completed) SI (Completed) FR (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2008-000587-17 Sponsor Protocol Number: MA21573 Start Date*: 2008-06-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequat...
    Medical condition: Rheumatoid arthritis.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) SE (Completed) ES (Completed) FI (Completed) IE (Completed) PT (Completed) CZ (Completed) DK (Completed) FR (Completed) BE (Completed) NL (Completed) HU (Completed) DE (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-011105-17 Sponsor Protocol Number: ML22462 Start Date*: 2009-05-17
    Sponsor Name:ROCHE
    Full Title: A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe ...
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-004108-37 Sponsor Protocol Number: CC-99677-AS-001 Start Date*: 2021-07-09
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis
    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 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Prematurely Ended) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2014-005606-38 Sponsor Protocol Number: CNTO1275UCO3001 Start Date*: 2015-10-07
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with M...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) AT (Completed) CZ (Completed) DK (Completed) NL (Completed) SK (Completed) BE (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001226-18 Sponsor Protocol Number: M14-431 Start Date*: 2018-04-17
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who H...
    Medical condition: Crohn's Disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) SE (Completed) DK (Completed) AT (Completed) PT (Completed) BE (Completed) IE (Completed) GB (GB - no longer in EU/EEA) LV (Completed) HU (Completed) DE (Completed) PL (Completed) CZ (Completed) LT (Completed) EE (Completed) ES (Completed) BG (Completed) SI (Completed) HR (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2009-012218-30 Sponsor Protocol Number: ML22648 Start Date*: 2009-10-06
    Sponsor Name:Roche Farmacêutica Química, Lda.
    Full Title: A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 w...
    Medical condition: Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: View results
    EudraCT Number: 2017-005059-10 Sponsor Protocol Number: Trp-IBD Start Date*: 2018-09-14
    Sponsor Name:Ghent University Hospital
    Full Title: Multicentric, double-blind, placebo controlled clinical trial with 5-hydroxytryptophan (5-HTP) in patients with inflammatory bowel disease in clinical and biologic remission: effect on fatigue scores
    Medical condition: Inflammatory Bowel Disease (IBD)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004468-23 Sponsor Protocol Number: version3.0 Start Date*: 2020-02-10
    Sponsor Name:St George's, University of London
    Full Title: Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial
    Medical condition: Rheumatoid arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-006924-68 Sponsor Protocol Number: MA22460 Start Date*: 2010-10-28
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARD...
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) ES (Completed) NL (Completed) CZ (Completed) PT (Completed) FR (Completed) IT (Completed) GB (Completed) HU (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2018-002925-47 Sponsor Protocol Number: GIS-2018-BioIBD Start Date*: 2018-12-28
    Sponsor Name:Fundación de Investigación Biomédica del Hospital Universitario de La Princesa
    Full Title: Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches
    Medical condition: Inflammatory bowel disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004918-18 Sponsor Protocol Number: OPTIMAP Start Date*: 2014-02-03
    Sponsor Name:Academic Medical Center
    Full Title: Optimising adalimumab treatment in psoriasis with concomitant methotrexate.
    Medical condition: psoriasis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004209-41 Sponsor Protocol Number: CNTO1275CRD3007 Start Date*: 2018-06-21
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Modera...
    Medical condition: Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) FR (Completed) PL (Completed) DE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) BG (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002537-41 Sponsor Protocol Number: 20170104 Start Date*: 2022-01-06
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Sev...
    Medical condition: Moderate to Severe Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) FI (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) RO (Trial now transitioned) SK (Trial now transitioned) LV (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002701-26 Sponsor Protocol Number: 64304500CRD2002 Start Date*: 2021-01-12
    Sponsor Name:JANSSEN CILAG INTERNATIONAL NV
    Full Title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standa...
    Medical condition: 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, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002150-79 Sponsor Protocol Number: ML28701 Start Date*: 2013-12-16
    Sponsor Name:N.V. Roche S.A.
    Full Title: TOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001163-37 Sponsor Protocol Number: CNTO1959PSA3001 Start Date*: 2017-07-25
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis i...
    Medical condition: Active Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-005390-36 Sponsor Protocol Number: UoL001109 Start Date*: 2016-02-17
    Sponsor Name:The University of Liverpool
    Full Title: Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab (IFX) verses alpha interferon (aIFN), with genotyping and metabolomic profiling, towards a str...
    Medical condition: Behcets Disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10004212 Behcet's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2004-005102-68 Sponsor Protocol Number: IM101-064 Start Date*: 2005-09-01
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARD...
    Medical condition: RHEUMATOID ARTHRITIS,NOS
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) ES (Completed) DE (Completed) BE (Completed) IT (Completed) CZ (Completed)
    Trial results: Removed from public view
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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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