Value through Innovation27 July 2016

Clinical Study Results

  • CYLTEZO ® - Healthy
    Clinical Study Number 1297.8
    Study Indication Healthy
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase I
    Study Title

    Pharmacokinetics and safety of BI 695501 in healthy subjects: a randomized, double-blind, single-dose, parallel-arm, active-comparator clinical Phase I study

    Study Document Trial synopsis 1297.8 english
  • CYLTEZO ® - Healthy
    Clinical Study Number 1297.6
    Study Indication Healthy
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase I
    Study Title

    Randomized, single-dose, parallel-arm, open-label Phase I trial to investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector (VOLTAIRE-AI)

    Study Document Trial synopsis 1297.6 english
  • CYLTEZO ® - Arthritis, Rheumatoid
    Clinical Study Number 1297.2
    Study Indication Arthritis, Rheumatoid
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase III
    Study Title

    Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

    Study Document Trial synopsis 1297.2 english Lay summary 1297.2 english
  • CYLTEZO ® - Arthritis, Rheumatoid
    Clinical Study Number 1297.11
    Study Indication Arthritis, Rheumatoid
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase II
    Study Title

    Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously with an Autoinjector in Patients with Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered with a Prefilled Syringe

    Study Document Trial synopsis 1297.11 english
  • CYLTEZO ® - Healthy
    Clinical Study Number 1297.13
    Study Indication Healthy
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase I
    Study Title

    Randomized, single-dose, parallel-arm, open-label Phase I trial to compare the pharmacokinetics, safety, and tolerability of BI 695501 administered subcutaneously via pre filled syringe or autoinjector (VOLTAIRE-TAI)

    Study Document Trial synopsis 1297.13 english
  • CYLTEZO ® - Healthy
    Clinical Study Number 1297.1
    Study Indication Healthy
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase I
    Study Title

    Pharmacokinetics and safety of BI 695501 in healthy subjects: a randomised, open-label, single-dose, parallel-arm, active-comparator clinical Phase I study

    Study Document Trial synopsis 1297.1 english
  • CYLTEZO ® - Arthritis, Rheumatoid
    Clinical Study Number 1297.3
    Study Indication Arthritis, Rheumatoid
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase IIIb
    Study Title

    Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis: an open-label extension trial for patients who have completed Trial 1297.2 and are eligible for long-term treatment with adalimumab (VOLTAIRE-RAext)

    Study Document Trial synopsis 1297.3 english

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