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
  • CYLTEZO ® - Psoriasis
    Clinical Study Number 1297.12
    Study Indication Psoriasis
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase III
    Study Title

    Efficacy, Safety, and Immunogenicity of BI 695501 versus Humira® in Patients with Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial

    Study Document Trial synopsis 1297.12 english Lay summary 1297.12 english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.