NCT01657513

Brief Summary

TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are well-tolerated with few side effects. Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration. The cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
2 countries

2 active sites

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

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

July 30, 2012

Last Update Submit

August 3, 2012

Conditions

Psoriasis

Keywords

psoriasistreatment failuretnf-alfa

Outcome Measures

Primary Outcomes (1)

  • change in concentration of tnf-alfa antibodies in serum

    Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies

    3, 6, and 12 months after start of tnf-alfa blocking agent

Secondary Outcomes (5)

  • change in severity of psoriasis, PASI

    3, 6, and 12 months after start of tnf-alfa blocking agent

  • Presence of psoriatic arthritis

    3, 6, and 12 months after start of tnf-alfa blocking agent

  • change in dermatology life quality index (DLQI)

    3, 6, and 12 months after start of tnf-alfa blocking agent

  • height (cm)

    3 months

  • change in weight (kg)

    3, 6, and 12 months after start of tnf-alfa blocking agent

Other Outcomes (1)

  • assessment of change in concentrations of other biomarkers of interest in psoriasis

    3, 6, and 12 months after start of tnf-alfa blocking agent

Study Arms (1)

tnf-alfa treatment (infliximab, adalimumab, or etanercept)

EXPERIMENTAL

This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug

Drug: subjects will receive either infliximab, adalimumab or etanercept

Interventions

subjects will receive either infliximab, adalimumab or etanerceptDRUG

The subjects receive treatment with a tnf-alfa blocking according to the official guidelines for the particular drug. The study subjects will receive treatment with one drug only - 1. infliximab or 2. adalimumab or 3. etanercept The consulting dermatologist decides which drug to use according to official guidelines

Also known as: infliximab, adalimumab, etanercept
tnf-alfa treatment (infliximab, adalimumab, or etanercept)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age above 18
  • Psoriasis
  • Indication for treatment with tnf alfa blocking drug
  • Written informed consent obtained

You may not qualify if:

  • Severe psychiatric disorder
  • No indication for treatment with tnf-alfa blocking drug
  • Pregnancy
  • Breastfeeding
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Copenhagen University Hospital Gentofte, Department of Skin and Allergies

Hellerup, 2900, Denmark

RECRUITING

Karolinska Institute, Department of Medicine

Stockholm, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

AdalimumabEtanerceptInfliximab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsImmunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesImmunoglobulin Constant RegionsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Lone Skov, MD, PhD

    Copenhagen University Hospital Gentofte, Department of Skin and Allergies

    STUDY DIRECTOR

  • Mona Ståhle, MD, PhD

    Karolinska Institute, Department of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Skov, MD, PhD

CONTACT

+4539773204lone.skov.02@regionh.dk

Peter Jensen, MD

CONTACT

+4539777538peter.jensen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 6, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

DK(1)SE(1)