Rheumatoid ArthritisSurviPredNCT03444623
Survivin as Predictive Biomarker for RA
An observational study of Rheumatoid Arthritis and Arthralgia, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis, Arthralgia, Joint Pain
- How many people
- 6,000 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2013to Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).
Who may be able to join
- Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).
Who cannot join
- Patients diagnosed with RA
Trial locations and contacts
1 site in 1 country.
Maria Bokarewa, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Dept of Rheumatology and Inflammation research
Gothenburg
Sofia T Silfverswärd, sofia.silfversward@rheuma.gu.se
About this study
Official title: Survivin as Predictive Biomarker for Development of Rheumatoid Arthritis
Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as a prognostic marker for joint destruction, refractory and highly active disease in patients with established RA.
Read the detailed description
The study will analyse survivin levels in a non-selected material within a cohort of patients seeking help at their primary health care for joint pain, stiffness, swelling etc. Patients presenting with such symptoms (not explained by injury or other factors) are suspected to have an arthritic condition such as RA, and are routinely tested for presence of autoantibodies RF and ACPA. In this observational study we add measurement for survivin to the blood analyses of these patients. Information about patients expressing high levels of survivin will be reported to the referring doctor at the primary health care, and for patients not previously having been examined by a rheumatologist this will be offered.
The study will be performed at Sahlgrenska university hospital Gothenburg and Umeå university hospital.
- Conditions
- Rheumatoid Arthritis, Arthralgia, Joint Pain
- Keywords
- predictive factor, prognostic factor
- Medical subject headings
- Arthritis, Rheumatoid, Arthralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivin positive
Survivin positive: > 0,45 ng/ml Survivin negative: < 0,45 ng/ml
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study startJun 2013
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444623
- Sponsor's protocol ID
- Survivin rutin
- Acronym
- SurviPred
- Status last verified
- May 2022
- First submitted
- 5 Feb 2018
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erlandsson MC, Malmhall-Bah E, Chandrasekaran V, Andersson KME, Nilsson LM, Toyra Silfversward S, Pullerits R, Bokarewa MI. Insulin Sensitivity Controls Activity of Pathogenic CD4+ T Cells in Rheumatoid Arthritis. Cells. 2024 Dec 22;13(24):2124. doi: 10.3390/cells13242124.
PubMed 39768214
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivin as Predictive Biomarker for Development of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03444623
- Acronym / sponsor ID
- SurviPred / Survivin rutin
- Conditions
- Rheumatoid Arthritis, Arthralgia, Joint Pain
- Keywords
- predictive factor, prognostic factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Feb 2018 (actual)
- 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.
Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as a prognostic marker for joint destruction, refractory and highly active disease in patients with established RA.
Detailed description
The study will analyse survivin levels in a non-selected material within a cohort of patients seeking help at their primary health care for joint pain, stiffness, swelling etc. Patients presenting with such symptoms (not explained by injury or other factors) are suspected to have an arthritic condition such as RA, and are routinely tested for presence of autoantibodies RF and ACPA. In this observational study we add measurement for survivin to the blood analyses of these patients. Information about patients expressing high levels of survivin will be reported to the referring doctor at the primary health care, and for patients not previously having been examined by a rheumatologist this will be offered.
The study will be performed at Sahlgrenska university hospital Gothenburg and Umeå university hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).
Key inclusion criteria (1 listed)
- Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).
Key exclusion criteria (1 listed)
- Patients diagnosed with RA
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
Survivin positive
Time frame: 1 year
Survivin positive: > 0,45 ng/ml Survivin negative: < 0,45 ng/ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 39768214Erlandsson MC, Malmhall-Bah E, Chandrasekaran V, Andersson KME, Nilsson LM, Toyra Silfversward S, Pullerits R, Bokarewa MI. Insulin Sensitivity Controls Activity of Pathogenic CD4+ T Cells in Rheumatoid Arthritis. Cells. 2024 Dec 22;13(24):2124. doi: 10.3390/cells13242124.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
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.
Maria Bokarewa, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Arthralgia, run by Vastra Gotaland Region at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Bokarewa, MD (maria.bokarewa@rheuma.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivin positive (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444623, which also lists 1 linked publication.
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 4 May 2022.