NCT02435238

Brief Summary

Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

21 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

3.1 years

First QC Date

December 2, 2014

Last Update Submit

February 14, 2018

Conditions

Chronic Urticaria

Outcome Measures

Primary Outcomes (1)

  • Measuring responses to PROs from patients on different treatments

    Measuring quality of life, work productivity and changes in disease for patients on different treatment.

    24 months

Secondary Outcomes (11)

  • To record use of clinical resources

    24 months

  • Previous, current and future medication

    24 months

  • The disease burden of chronic urticaria

    24 months

  • Rates of spontaneous remission

    24 months

  • Treatment algorithms and trends

    24 months

  • +6 more secondary outcomes

Eligibility Criteria

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

Chronic Urticaria Patients

You may qualify if:

  • Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months.
  • Subject must be refactory to at least one H1 antihistamine

You may not qualify if:

  • Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months.
  • Subjects taking must not take part in any other concurrent urticarial study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Novartis Investigative Site

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Novartis Investigative Site

Darlington, Durham, DL3 6HX, United Kingdom

Location

Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Salford, Manchester, M6 8HD, United Kingdom

Location

Novartis Investigative Site

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Novartis Investigative Site

Belfast, BT12 6BA, United Kingdom

Location

Novartis Investigative Site

Belfast, BT9 7AB, United Kingdom

Location

Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom

Location

Novartis Investigative Site

Chester, CH2 1UL, United Kingdom

Location

Novartis Investigative Site

Durham, DH1 6TW, United Kingdom

Location

Novartis Investigative Site

East Yorkshire, HU16 5JQ, United Kingdom

Location

Novartis Investigative Site

Kent, CT9 4AN, United Kingdom

Location

Novartis Investigative Site

Leeds, LS9 7PN, United Kingdom

Location

Novartis Investigative Site

Leicester, LE1 5WW, United Kingdom

Location

Novartis Investigative Site

Liverpool, L14 3PE, United Kingdom

Location

Novartis Investigative Site

London, SE18 4QH, United Kingdom

Location

Novartis Investigative Site

Manchester, M13 9WL, United Kingdom

Location

Novartis Investigative Site

Manchester, M23 9LT, United Kingdom

Location

Novartis Investigative Site

Middlesbrough, TS4 3BW, United Kingdom

Location

Novartis Investigative Site

Poole, BH15 2JB, United Kingdom

Location

Novartis Investigative Site

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

May 6, 2015

Study Start

September 3, 2014

Primary Completion

September 27, 2017

Study Completion

September 27, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

GB(21)