NCT01673633

Brief Summary

One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular involvement. Mostly involved joints in SSc were reported as wrist, carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this joint in SSc.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Status
completed

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

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

First QC Date

August 23, 2012

Last Update Submit

August 27, 2012

Conditions

Systemic SclerosisSacroiliitisInflammatory Back Pain

Outcome Measures

Primary Outcomes (1)

  • The frequency of sacroiliitis in systemic sclerosis

    One year

Study Arms (3)

SSc

Sacroiliitis

Rheumatoid arthritis

Sacroiliitis

Healthy controls

Sacroiliitis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive systemic sclerosis and rheumatoid arthritis patients and healthy volunteers

You may qualify if:

  • Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers

You may not qualify if:

  • Not giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, SystemicSacroiliitis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesArthritisJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internist and rheumatologist

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 28, 2012

Study Start

January 1, 2012

Last Updated

August 28, 2012

Record last verified: 2012-08