Value through Innovation27 July 2016

Clinical Study Results

  • Amelubant - Arthritis, Rheumatoid
    Clinical Study Number 543.14
    Study Indication Arthritis, Rheumatoid
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I/IIa
    Study Title

    A double-blind, randomized, three parallel group placebo-controlled study to investigate pharmacokinetics, effect on expression of CD11b/CD18 (Mac-1), as well as safety and efficacy of two oral doses of BIIL 284 BS (dosage: 25 mg daily, 150 mg daily) in patients with rheumatoid arthritis over two weeks.

    Study Document Trial synopsis 543.14 english
  • Amelubant - Arthritis, Rheumatoid
    Clinical Study Number 543.27
    Study Indication Arthritis, Rheumatoid
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Three month, randomised, double-blind, double-dummy, placebo controlled, multiple dose-range study of the efficacy and safety of BIIL284 BS (5, 25 and 75 mg p.o. once daily) in adult patients with active Rheumatoid Arthritis

    Study Document Trial synopsis 543.27 english
  • Doramapimod - Arthritis, Rheumatoid
    Clinical Study Number 1175.11
    Study Indication Arthritis, Rheumatoid
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, parallel, double-blind, placebo-controlled study to investigate efficacy and safety of different doses (5, 10, 20 and 30 mg) of BIRB 796 BS administered twice a day orally over 4 weeks in patients with active Rheumatoid Arthritis who have failed at least one DMARD

    Study Document Trial synopsis 1175.11 english
  • Doramapimod - Arthritis, Rheumatoid
    Clinical Study Number 1175.18
    Study Indication Arthritis, Rheumatoid
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase II
    Study Title

    A 12 week double-blind randomised, placebo-controlled trial to investigate efficacy, safety and pharmacokinetics of BIRB 796 BS tablets at doses of 50 and 70 mg administered twice daily in patients with active rheumatoid arthritis who have failed at least one DMARD

    Study Document Trial synopsis 1175.18 english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.258
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A Multi-Center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients with Rheumatoid Arthritis

    Study Document Trial synopsis 107.258_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.266
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, open-labelled study to compare the efficacy and safety of meloxicam 15 mg IM ampoules once daily and meloxicam 15 mg tablets administered orally once daily over a period of 7 days in patients with RA.

    Study Document Trial synopsis 107.266_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.267
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Meloxicam (MOBIC®) ampoule post marketing surveillance study

    Study Document Trial synopsis 107.267_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.245
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    COX-2 postmarketing surveillance study with MOBEC® 15 mg tablets

    Study Document Trial synopsis 107.245_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.246
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Safety and efficacy of meloxicam (MOBIC) compared to other NSAIDs in approved therapeutic dosages and routes of administration in an observational cohort study of patients with Rheumatoid arthritis, Osteoarthritis, Lumbago, Scapulohumerla periarthritis, Neck, shoulder and arm syndrome

    Study Document Trial synopsis 107.246 english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.249
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Personalized Therpeutic Experience Program (Programa de Experiencia Terapeutica Personalizada)

    Study Document Trial synopsis 107.249 english
  • BI 695500 - Arthritis, Rheumatoid
    Clinical Study Number 1301.1
    Study Indication Arthritis, Rheumatoid
    Product BI 695500
    Generic Name BI 695500
    Lab Code
    Clinical Phase I/III
    Study Title

    Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

    Study Document Trial statement 1301.1 english Trial synopsis 1301.1_DS english
  • BI 695500 - Arthritis, Rheumatoid
    Clinical Study Number 1301.4
    Study Indication Arthritis, Rheumatoid
    Product BI 695500
    Generic Name BI 695500
    Lab Code
    Clinical Phase III
    Study Title

    Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

    Study Document Trial statement 1301.4 english Trial synopsis 1301.4_DS 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 ® - 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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