Systemic SclerosisNCT01673633
Sacroiliitis in Systemic Sclerosis
An observational study of Systemic Sclerosis and Sacroiliitis, run by Cukurova University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Sacroiliitis, Inflammatory Back Pain
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive systemic sclerosis and rheumatoid arthritis patients and healthy volunteers
Who may be able to join
- Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers
Who cannot join
- Not giving informed consent
About this study
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.
- Conditions
- Systemic Sclerosis, Sacroiliitis, Inflammatory Back Pain
- Medical subject headings
- Scleroderma, Systemic, Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SSc | Sacroiliitis | |
| Rheumatoid arthritis | Sacroiliitis | |
| Healthy controls | Sacroiliitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of sacroiliitis in systemic sclerosis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Arslan Tas, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673633
- Sponsor's protocol ID
- Sacroiliitis in SSc
- Other IDs
- 05/01/2012-4/21
- Status last verified
- Aug 2012
- First submitted
- 23 Aug 2012
- Last updated
- 28 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacroiliitis in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01673633
- Acronym / sponsor ID
- Sacroiliitis in SSc
- Conditions
- Systemic Sclerosis, Sacroiliitis, Inflammatory Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jan 2012
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SSc | – | –Sacroiliitis |
| Rheumatoid arthritis | – | –Sacroiliitis |
| Healthy controls | – | –Sacroiliitis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive systemic sclerosis and rheumatoid arthritis patients and healthy volunteers
Key inclusion criteria (1 listed)
- Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers
Key exclusion criteria (1 listed)
- Not giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The frequency of sacroiliitis in systemic sclerosis
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Sacroiliitis, run by Cukurova University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of sacroiliitis in systemic sclerosis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012.