Sacroiliitis in Systemic Sclerosis | NCT01673633

Studies
Sacroiliitis in Systemic Sclerosis

NCT01673633

Sponsor

Cukurova University

Status

Completed

Last Update Posted

Aug 28, 2012Estimated

Enrollment

175Actual

Phase

Not provided

Conditions

Systemic Sclerosis
Sacroiliitis
Inflammatory Back Pain

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
05/01/2012-4/21	Other Identifier	05/01/2012-4/21

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 23, 2012

First Submission Date that Met QC Criteria

Aug 27, 2012

First Posted Date

Aug 28, 2012Estimated

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

Aug 27, 2012

Last Update Posted Date

Aug 28, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SSc		Sacroiliitis
Rheumatoid arthritis		Sacroiliitis
Healthy controls		Sacroiliitis

Interventions

Not provided

Measure	Description	Time Frame
The frequency of sacroiliitis in systemic sclerosis		One year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers

Exclusion Criteria:

Not giving informed consent

Accepts Healthy Volunteers

Yes

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

Consecutive systemic sclerosis and rheumatoid arthritis patients and healthy volunteers

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic
D058566	Sacroiliitis

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases
D001168	Arthritis

Browse Leaves

Not provided

Browse Branches

Not provided