NCT01744327

Brief Summary

TL1A is a newly discovered signal molecule that may be crucially involved in the maintenance of chronic inflammatory disorders. TL1A has also been demonstrated in psoriatic skin but the importance of TL1A in psoriasis is still unknown. Understanding inflammatory signal molecules in psoriasis is important because the development of new drugs directed against relevant signal molecules (e.g. TNF-α and IL12/23) has proved to be a very efficacious treatment principle. However, despite the dramatic progress in therapeutic options during the last decade, there is still a fraction of patients that are insufficiently treated with the currently available therapies. TL1A has been claimed to be the next important target for development of biologics in the field of chronic inflammation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

December 5, 2012

Last Update Submit

May 27, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Expression of TL1A in psoriatic skin

    Staining intensity of TL1A by IHC in involved psoriatic skin compared to uninvolved and skin from normal controls

    3 months

Study Arms (1)

Chronic Plaque type psoriasis

Patients with plaque type psoriasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Plaque type psoriasis

You may qualify if:

  • Plaque type psoriasis
  • at least 6 month history of psoriasis

You may not qualify if:

  • systemic anti-psoriatic medication
  • topical anti-psoriatic medication (wash-out period 2 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of dermatology D40 , Bispebjerg Hospital

Copenhagen, 2400 NV, Denmark

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician, Associate Professor

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 6, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations