Case Study 4

Phase IIIb Trial in Adolescent Patients with Plaque Psoriasis

SITUATION

As part of our experience in this indication, TFS is proud to present a case study of a Phase IIIb trial we conducted in adolescent patients with plaque psoriasis. This case study demonstrates our knowledge of this indication and the value we add to the trials we conduct.

Study Phase: IIIb

Indication/Patient Population: Plaque psoriasis

Number of Patients: 130

Sites: 20

Services: Full Service

CHALLENGES

  • The study involved adolescents and therefore increased challenges for patient recruitment.
  • There have been Progressive Multifocal Leukoencephalopathy (PML) cases during therapy with Fumaric Acid Esters (FAEs) – an ongoing worldwide discussion and possible safety concerns of this treatment lead to uncertainty around monitoring rules.
  • There was a competitive environment with significant numbers of psoriasis studies ongoing.
  • Certain drug characteristics (slow onset of action, gastrointestinal symptoms, flushing) and monitoring rules required explanation to physicians and patients.
  • There was a highly competitive treatment landscape with several biologics available (including some with ‘’first line label”) with strong sales force and remarkable efficacy data and a rapid onset of efficacy compared to FAEs.
  • There was a high dropout rate due to placebo and GI symptoms.

TFS SOLUTION

  • TFS utilised exceptional and close communication between the Sponsor, TFS Project Management, and the CRAs to ensure issues and site concerns were addressed, and successfully resolved, within a timely manner.
  • The TFS Medical Monitor engaged with sites to monitor possible PML and the appropriate inclusion and exclusion of patients.
  • Our flexibility ensures that a tailored approach to site support was provided, with individual requirements depending on the need of individual site staff, thereby achieving high quality documentation at sites.
  • Our focus on quality during the conduct of the study succeeded in successful authority inspections of sites, the sponsor and TFS.
  • Despite critical timelines for Clinical Study Report (CSR) completion, all interim milestones were met due to TFS’ strict prioritisation of study goals and close collaboration across all departments between TFS and the Sponsor.

CLIENT ADVANTAGE

The synergy of TFS’ experience and staff expertise provided a full-service business solution, which was pivotal in support of the client’s need for efficient study management of a high quality standard.