to Translate and Validate the TOPAS TORONTO PSORIATIC SCR... | NCT01891903

Studies
to Translate and Validate the TOPAS TORONTO PSORIATIC SCREENING QUESTIONNAIRE)Into Spanish

NCT01891903

Sponsor

Reumatologia Integral LTDA

Status

Unknown status

Last Update Posted

Jul 3, 2013Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Psoriatic Arthritis

Interventions

Not provided

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Aug 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Jun 18, 2013

First Submission Date that Met QC Criteria

Jun 28, 2013

First Posted Date

Jul 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2013

Last Update Posted Date

Jul 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adriana Beltran, ADRIANA BELTRAN OSTOS, Reumatologia Integral LTDAPrincipal Investigator

Lead Sponsor

Reumatologia Integral LTDAOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

TO TRANSALETE AND VALIDATE DE TORONTO PSORIATIC ARTHRITIS SECREENING QUESTIONAIRE INTO SPANISH

Detailed Description

THIS IS PART OF THE COLOMBIAN REGISTRY OF PATIENTS WITH PSORIASIS AND PSORIATIC ARTHRITIS

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Kuder Richardson Coefficient of reliability (K-R 20)		4 MONTHS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ADULT WITH PSORIASIS IN THE DERMATOLOGY CLINIC

Exclusion Criteria:

ADULT WITH OTHER AUTOIMMUNE DISEASE

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

PATIENTS WITH PSORIASIS ASESSED IN THE DERMATOLOGY CLINIC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Fernandez, rheumatolo	hospital san ignasio	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Clinica San Rafael	Recruiting	Bogota	Cundinamarca	12345	Colombia

Condition Browse Module

MeSH Terms

ID	Term
D015535	Arthritis, Psoriatic

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided