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Completed

NCT Number: NCT01373567

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Durgabai Deshmukh Hospital & Research Center, Hyderabad, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TINEFCON

Drug

Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

Primary outcomes

  1. 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

  1. Gene expression profiling and Immunohistochemistry

    Time frame: At baseline and week 12 or early termination

  2. Physicians global assessment score

    Time frame: At week 4, week 8 and week 12 / early termination visit

  3. Nail psoriasis severity index

    Time frame: At baseline and at week 12 or early termination

  4. Psoritic arthritis evaluation

    Time frame: At baseline and week 12 or early termination

Sponsors and collaborators

Lead sponsor

Piramal Enterprises Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2011
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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