NCT01373567

A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

An Open Label, Non-comparative, Multicentre, Phase IV Study to Evaluate the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting approximately 2% of the world's population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from psoriasis under conditions of actual use and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients treated with Tinefcon. This study will add to literature on the risks and benefits of Tinefcon the novel oral TNF-alpha release inhibitor.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	TINEFCON	Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-02-01
• Completion: 2012-06-01
• First posted: 2011-06-15
• Last updated: 2012-11-22

Locations

23 sites across 1 country: India