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

Piramal Enterprises Limited23 sites in 1 country298 target enrollmentDecember 2010

ConditionsPlaque Psoriasis

InterventionsTINEFCON

DrugsTINEFCON

Overview

Phase: Phase 4
Intervention: TINEFCON
Conditions: Plaque Psoriasis
Sponsor: Piramal Enterprises Limited
Enrollment: 298
Locations: 23
Primary Endpoint: Change in Psoriasis area severity index score
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Piramal Enterprises Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects of at least 18 years of age with clinical diagnosis of plaque psoriasis
•Subject who understand and willing to sign informed consent document before start of any study specific assessment

Exclusion Criteria

•Pregnant and lactating females
•Subject with active infection, acute or chronic due to bacteria, viruses, fungi or parasites (most notably tuberculosis, and chronic hepatitis B)
•Subject with heart failure (New York Heart Association class III or IV)
•Subject with demyelinating disease
•Subject with solid cancer or hematologic malignancy diagnosed within last 5 years with a potential for progression
•Women of childbearing potential \[defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)\] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) after signing an informed consent document (ICD), during the duration of study participation and for at least 4 week after withdrawal from the study, unless they are surgically sterilized
•Subject with situations associated with a high risk of infection such as latent untreated tuberculosis, joint prosthesis infection within last 12 months, indwelling urinary catheter, uncontrolled diabetes, chronic obstructive pulmonary disease, skin ulcer
•Subject with known premalignant lesions (such as polyps in the colon or urinary bladder, cervical dysplasia and myelodysplasia)
•Subject known to be seropositive and/or clinically suspected to have the human immunodeficiency virus infection
•Subject with any condition that might make it difficult for the subject to participate in the study, at the discretion of the Investigator.

Arms & Interventions

TINEFCON

Tablets of 700 mg.

Intervention: TINEFCON

Outcomes

Primary Outcomes

Change in Psoriasis area severity index score

Time Frame: At week 4, week 8 and week 12 or early termination

Change from baseline at week 4, week 8 and week 12 or early termination

Secondary Outcomes

Gene expression profiling and Immunohistochemistry(At baseline and week 12 or early termination)
Physicians global assessment score(At week 4, week 8 and week 12 / early termination visit)
Nail psoriasis severity index(At baseline and at week 12 or early termination)
Psoritic arthritis evaluation(At baseline and week 12 or early termination)