Hand RheumatismRMNLESNCT04035265
Application of MRI for Musculoskeletal Involvement in SLE
A study testing Blood test in people with Hand Rheumatism and Systemic Lupus Erythematosus Arthritis, run by Hospital del Mar at 1 site in Spain.
Trial summary
Articular involvement can reach up to 95% within the chronic multisystemic manifestations of SLE (1). Originally, a non-erosive pattern of articular inflammation was described, but the emergence of more sensitive imaging techniques, such as MRI (2, 3), show synovitis, erosions (hand: 47-48%, carpus 82-84% in SLE; and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand Rheumatism, Systemic Lupus Erythematosus Arthritis
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2018to May 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients affected by SLE (1982 revised criteria) with scheduled visits to the SLE specialized medical office at Hospital del Mar:
- (pain+ / synovitis +): SLE patients with inflammatory pain and synovitis determined by the practitioner during physical examination of radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP . Defining synovitis as pain and inflammation and/or deformity (present or existing over the past year) included in the clinical history
- (pain + / synovitis -) SLE patients with inflammatory pain without determined synovitis . Current (or over the past year) pain in radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP, with no synovitis
- (pain - / synovitis -) SLE patients without inflammatory pain with normal physical examination currently or over the past year
- Control patients, without SLE nor immediate relatives affected by systemic inflammatory diseases, who lack articular pain and have blood test with no elevation APR or autoimmunity +)
Who cannot join
- Jaccoud's arthropaty
- RF + and/or ACPA +
- Incomplete SLE, MCTD, overlap syndromes
- Hand surgery
- Current neoplasia
- Non-rheumatoid systemic autoimmune diseases
- Contraindication for MRI
Trial locations and contacts
1 site in 1 country.
Tarek Carlos Salman, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
PAtricia Corzo Salman, MD, +34655057358, pcorzoreumatologia@gmail.com
About this study
Official title: Application of MRI for Inflammatory Musculoskeletal Involvement in Systemic Lupus Erithematosus (SLE)
Articular involvement can reach up to 95% within the chronic multisystemic manifestations of SLE (1). Originally, a non-erosive pattern of articular inflammation was described, but the emergence of more sensitive imaging techniques, such as MRI (2, 3), show synovitis, erosions (hand: 47-48%, carpus 82-84% in SLE; and hand: 18%, carpus 97% in healthy individuals), bone oedema (hand: 4-5%, carpus 13-16% in SLE; and 0% in healthy individuals) and tenosynovitis (hand 47%, carpus 79%; not evaluated in healthy individuals) in patients with SLE (4, 5). Nowadays, a specific validated pattern of articular involvement associated with this disease does not yet exist, although it has begun to be studied. This research tries to evaluate the presence, frequency and distribution of inflammatory articular manifestations in SLE (erosions, bone oedema, synovitis or tenosynovitis) using MRI (6), with the objective of trying to establish a specific pattern for this disease, if it exists, that can shorten the diagnostic process. Moreover, it tries to characterise, if they exist, clinical differences between various patient groups according to their articular involvement.
Read the detailed description
BACKGROUND AND RATIONALE
- Nowadays no valid classification system for SLE-related arthritis/tenosynovitis exists.
- Data are not sufficient to establish an SLE-specific pattern of inflammatory involvement, similar to the pattern known for other inflammatory diseases such as rheumatoid arthritis (RA).
- Erosive arthritis associated with SLE has been typically related to patients that meet the criteria both for SLE and RA - syndrome known as Rhupus; but only a few data exist that classify erosive involvement of articular inflammation of pure SLE.
- No research exists that links the articular inflammatory pathology associated with SLE with its effect on quality of life (degree of fatigue and HAQ) or with the rest of manifestations and comorbidities associated with SLE.
- Being able to predict the development of SLE-related arthritis/tenosynovitis would be very useful when it comes to establishing the clinical management, treatment and prognosis of patients with SLE.
OBJECTIVES
- GENERAL:
- To describe the kind of inflammatory articular involvement (synovitis/erosions/bone oedema/tenosynovitis) (6,7) and its frequency in patients affected by pure SLE (excluding Rhupus, mixed connective tissue disease, overlap syndromes).
- SPECIFIC:
- To propose, if possible, an SLE-specific typical pattern of articular involvement.
- To establish clinical and serological differences (extra-articular manifestations, autoimmunity, treatment received, comorbidities and quality of life) according to the type of inflammatory articular involvement and in comparison to healthy individuals.
- To evaluate the possible link between SLEDAI/SLICC scores and the involvement using MRI.
HYPOTHESIS
- Patients with SLE have a specific inflammatory articular disease.
- A SLE-specific pattern of articular involvement exists.
- There are clinical and serological differences depending on the different patterns of articular involvement in SLE.
- Being tested
- Blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
Also called hand MRI
Carpus and fingers of non-dominating hand MRI with gadolinium contrast
| Study group | Role | What they receive |
|---|---|---|
| pain+ / synovitis + | Active comparator | SLE patients with inflammatory pain and synovitis determined by the practitioner during physical examination of radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP. Defining synovitis as pain and inflammation and/or deformity (present or existing over the past year) included in the clinical history Receives: Procedure: Blood test |
| pain + / synovitis - | Active comparator | SLE patients with inflammatory pain without determined synovitis. Current (or over the past year) pain in radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP, with no synovitis Receives: Procedure: Blood test |
| pain - / synovitis - | Active comparator | SLE patients without inflammatory pain with normal physical examination currently or over the past year Receives: Procedure: Blood test |
| healthy | Placebo comparator | control patients (healthy participants: no pain, no SLE, no family affected by systemic inflammatory disease, a blood test with no elevation APR or autoimmunity +) Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI inflamatory changes
synovitis, erosions, bone oedema, tenosynovitis
Measured: 1 to 2 months after clinical assesment
SLE activity scale
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Measures last 10 days disease activity (rating (Y/N) 24 items related to specific manifestations on 9 organs) From 0 (best) to 105 (worst)
Measured: at clinical assesment
SLE treatments used
Number (n and %) of participants using any approved treatments for SLE used since diagnosis
Measured: at clinical assesment
Fatigue
Fatigue Severity Scale (FSS-9) Results from 9 (best) to 63 (worst): rating 9 items ranging from 1(best) to 7 (worst)
Measured: 2 weeks before the performance of MRI
Quality of life scale
modified health assessment questionnaire (MHAQ): Results from 0 (best) to 3 (worst): rating 9 items from 0 (best) to 3 (worst) (results given divided by 8)
Measured: 2 weeks before the performance of MRI
SLE damage scale
Systemic Lupus International Collaborating Clinics (SLICC) damage index:
Irreversible damage rated by: 42 items related to 12 organs: 0 (absent-best)/1 (present-worst), some of them can count 2 or 3 (worst) if recidivant.
From 0 (best) to 46 (worst)
Measured: at clinical assesment
Secondary outcomes (10)
Serological markers of disease activity: antinuclear antibodies (ANA)
ANA (dilution): given by titters (average titters comapred between groups)
Measured: 6 months prior to 6 months after assesment
Systemic SLE manifestations
presence of renal, lung, skin, neurological, haematological manifestations since diagnostic (Yes/No)
Measured: at clinical assesment
Hand pain visual analogue scale (VAS)
VAS 0 (none) to 10 (maximum)
Measured: at clinical assesment
Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds)
Titters DNAds (UI/ml)
Measured: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: Anti-Smith antibodies (Sm)
Presence of Sm (Yes/No)
Measured: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: complement 3 (C3)
titters C3 (mg/dL)
Measured: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: complement 4 (C4)
titters C4 (mg/dl)
Measured: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: erythrocyte sedimentation rate (ESR)
ESR (mm/h)
Measured: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: C reactive protein (CRP)
CRP (mg/dl)
Measured: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity:white cell blood count (WCBC)
WCBC: cellsx10E9/L
Measured: 6 months prior to 6 months after assesment (the closest to MRI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Dec 2018
- Primary completionJan 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hand RheumatismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1. Lupus with synovitis 2. Lupus with joint pain 3. Lupus without synovitis/joint pain 4. Healthy subjects
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Corzo, Hospital del Mar
- Investigators
- PAtricia corzo, MD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035265
- Sponsor's protocol ID
- RMNLES
- Acronym
- RMNLES
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be used for PhD investigations. IPD will not be shared with other researchers
Publications
Ball EM, Bell AL. Lupus arthritis--do we have a clinically useful classification? Rheumatology (Oxford). 2012 May;51(5):771-9. doi: 10.1093/rheumatology/ker381. Epub 2011 Dec 15.
PubMed 22179731Mosca M, Tani C, Carli L, Vagnani S, Possemato N, Delle Sedie A, Cagnoni M, D'Aniello D, Riente L, Caramella D, Bombardieri S. The role of imaging in the evaluation of joint involvement in 102 consecutive patients with systemic lupus erythematosus. Autoimmun Rev. 2015 Jan;14(1):10-5. doi: 10.1016/j.autrev.2014.08.007. Epub 2014 Aug 23.
PubMed 25183245Tani C, D'Aniello D, Possemato N, Delle Sedie A, Caramella D, Bombardieri S, Mosca M. MRI pattern of arthritis in systemic lupus erythematosus: a comparative study with rheumatoid arthritis and healthy subjects. Skeletal Radiol. 2015 Feb;44(2):261-6. doi: 10.1007/s00256-014-2033-0. Epub 2014 Oct 24.
PubMed 25341505Boutry N, Hachulla E, Flipo RM, Cortet B, Cotten A. MR imaging findings in hands in early rheumatoid arthritis: comparison with those in systemic lupus erythematosus and primary Sjogren syndrome. Radiology. 2005 Aug;236(2):593-600. doi: 10.1148/radiol.2361040844. Epub 2005 Jun 21.
PubMed 15972342Ostergaard M, Peterfy C, Conaghan P, McQueen F, Bird P, Ejbjerg B, Shnier R, O'Connor P, Klarlund M, Emery P, Genant H, Lassere M, Edmonds J. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Core set of MRI acquisitions, joint pathology definitions, and the OMERACT RA-MRI scoring system. J Rheumatol. 2003 Jun;30(6):1385-6.
PubMed 12784422Haavardsholm EA, Ostergaard M, Ejbjerg BJ, Kvan NP, Kvien TK. Introduction of a novel magnetic resonance imaging tenosynovitis score for rheumatoid arthritis: reliability in a multireader longitudinal study. Ann Rheum Dis. 2007 Sep;66(9):1216-20. doi: 10.1136/ard.2006.068361. Epub 2007 Mar 28.
PubMed 17392347
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of MRI for Inflammatory Musculoskeletal Involvement in Systemic Lupus Erithematosus (SLE)
- ClinicalTrials.gov ID
- NCT04035265
- Acronym / sponsor ID
- RMNLES / RMNLES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 29 Jul 2019 (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.
Articular involvement can reach up to 95% within the chronic multisystemic manifestations of SLE (1). Originally, a non-erosive pattern of articular inflammation was described, but the emergence of more sensitive imaging techniques, such as MRI (2, 3), show synovitis, erosions (hand: 47-48%, carpus 82-84% in SLE; and hand: 18%, carpus 97% in healthy individuals), bone oedema (hand: 4-5%, carpus 13-16% in SLE; and 0% in healthy individuals) and tenosynovitis (hand 47%, carpus 79%; not evaluated in healthy individuals) in patients with SLE (4, 5). Nowadays, a specific validated pattern of articular involvement associated with this disease does not yet exist, although it has begun to be studied. This research tries to evaluate the presence, frequency and distribution of inflammatory articular manifestations in SLE (erosions, bone oedema, synovitis or tenosynovitis) using MRI (6), with the objective of trying to establish a specific pattern for this disease, if it exists, that can shorten the diagnostic process. Moreover, it tries to characterise, if they exist, clinical differences between various patient groups according to their articular involvement.
Detailed description
BACKGROUND AND RATIONALE
- Nowadays no valid classification system for SLE-related arthritis/tenosynovitis exists.
- Data are not sufficient to establish an SLE-specific pattern of inflammatory involvement, similar to the pattern known for other inflammatory diseases such as rheumatoid arthritis (RA).
- Erosive arthritis associated with SLE has been typically related to patients that meet the criteria both for SLE and RA - syndrome known as Rhupus; but only a few data exist that classify erosive involvement of articular inflammation of pure SLE.
- No research exists that links the articular inflammatory pathology associated with SLE with its effect on quality of life (degree of fatigue and HAQ) or with the rest of manifestations and comorbidities associated with SLE.
- Being able to predict the development of SLE-related arthritis/tenosynovitis would be very useful when it comes to establishing the clinical management, treatment and prognosis of patients with SLE.
OBJECTIVES
- GENERAL:
- To describe the kind of inflammatory articular involvement (synovitis/erosions/bone oedema/tenosynovitis) (6,7) and its frequency in patients affected by pure SLE (excluding Rhupus, mixed connective tissue disease, overlap syndromes).
- SPECIFIC:
- To propose, if possible, an SLE-specific typical pattern of articular involvement.
- To establish clinical and serological differences (extra-articular manifestations, autoimmunity, treatment received, comorbidities and quality of life) according to the type of inflammatory articular involvement and in comparison to healthy individuals.
- To evaluate the possible link between SLEDAI/SLICC scores and the involvement using MRI.
HYPOTHESIS
- Patients with SLE have a specific inflammatory articular disease.
- A SLE-specific pattern of articular involvement exists.
- There are clinical and serological differences depending on the different patterns of articular involvement in SLE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 1. Lupus with synovitis 2. Lupus with joint pain 3. Lupus without synovitis/joint pain 4. Healthy subjects
| Arm | Type | Receives |
|---|---|---|
| pain+ / synovitis + | Active comparator | Procedure: Blood testSLE patients with inflammatory pain and synovitis determined by the practitioner during physical examination of radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP. Defining synovitis as pain and inflammation and/or deformity (present or existing over the past year) included in the clinical history |
| pain + / synovitis - | Active comparator | Procedure: Blood testSLE patients with inflammatory pain without determined synovitis. Current (or over the past year) pain in radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP, with no synovitis |
| pain - / synovitis - | Active comparator | Procedure: Blood testSLE patients without inflammatory pain with normal physical examination currently or over the past year |
| healthy | Placebo comparator | Procedure: Blood testcontrol patients (healthy participants: no pain, no SLE, no family affected by systemic inflammatory disease, a blood test with no elevation APR or autoimmunity +) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients affected by SLE (1982 revised criteria) with scheduled visits to the SLE specialized medical office at Hospital del Mar:
- (pain - / synovitis -) SLE patients without inflammatory pain with normal physical examination currently or over the past year
- Control patients, without SLE nor immediate relatives affected by systemic inflammatory diseases, who lack articular pain and have blood test with no elevation APR or autoimmunity +)
Key exclusion criteria (7 listed)
- Jaccoud's arthropaty
- RF + and/or ACPA +
- Incomplete SLE, MCTD, overlap syndromes
- Hand surgery
- Current neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAlso: hand MRICarpus and fingers of non-dominating hand MRI with gadolinium contrast | Procedure or surgery | healthy, pain + / synovitis -, pain - / synovitis -, pain+ / synovitis + |
Primary outcome
MRI inflamatory changes
Time frame: 1 to 2 months after clinical assesment
synovitis, erosions, bone oedema, tenosynovitis
SLE activity scale
Time frame: at clinical assesment
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Measures last 10 days disease activity (rating (Y/N) 24 items related to specific manifestations on 9 organs) From 0 (best) to 105 (worst)
SLE treatments used
Time frame: at clinical assesment
Number (n and %) of participants using any approved treatments for SLE used since diagnosis
Fatigue
Time frame: 2 weeks before the performance of MRI
Fatigue Severity Scale (FSS-9) Results from 9 (best) to 63 (worst): rating 9 items ranging from 1(best) to 7 (worst)
Quality of life scale
Time frame: 2 weeks before the performance of MRI
modified health assessment questionnaire (MHAQ): Results from 0 (best) to 3 (worst): rating 9 items from 0 (best) to 3 (worst) (results given divided by 8)
SLE damage scale
Time frame: at clinical assesment
Systemic Lupus International Collaborating Clinics (SLICC) damage index: Irreversible damage rated by: 42 items related to 12 organs: 0 (absent-best)/1 (present-worst), some of them can count 2 or 3 (worst) if recidivant. From 0 (best) to 46 (worst)
10 secondary outcomes
Serological markers of disease activity: antinuclear antibodies (ANA)
Time frame: 6 months prior to 6 months after assesment
Systemic SLE manifestations
Time frame: at clinical assesment
Hand pain visual analogue scale (VAS)
Time frame: at clinical assesment
Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds)
Time frame: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: Anti-Smith antibodies (Sm)
Time frame: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: complement 3 (C3)
Time frame: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: complement 4 (C4)
Time frame: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: erythrocyte sedimentation rate (ESR)
Time frame: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: C reactive protein (CRP)
Time frame: 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity:white cell blood count (WCBC)
Time frame: 6 months prior to 6 months after assesment (the closest to MRI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Background: PubMed 22179731Ball EM, Bell AL. Lupus arthritis--do we have a clinically useful classification? Rheumatology (Oxford). 2012 May;51(5):771-9. doi: 10.1093/rheumatology/ker381. Epub 2011 Dec 15.
- Background: PubMed 25183245Mosca M, Tani C, Carli L, Vagnani S, Possemato N, Delle Sedie A, Cagnoni M, D'Aniello D, Riente L, Caramella D, Bombardieri S. The role of imaging in the evaluation of joint involvement in 102 consecutive patients with systemic lupus erythematosus. Autoimmun Rev. 2015 Jan;14(1):10-5. doi: 10.1016/j.autrev.2014.08.007. Epub 2014 Aug 23.
- Background: PubMed 25341505Tani C, D'Aniello D, Possemato N, Delle Sedie A, Caramella D, Bombardieri S, Mosca M. MRI pattern of arthritis in systemic lupus erythematosus: a comparative study with rheumatoid arthritis and healthy subjects. Skeletal Radiol. 2015 Feb;44(2):261-6. doi: 10.1007/s00256-014-2033-0. Epub 2014 Oct 24.
- Background: PubMed 15972342Boutry N, Hachulla E, Flipo RM, Cortet B, Cotten A. MR imaging findings in hands in early rheumatoid arthritis: comparison with those in systemic lupus erythematosus and primary Sjogren syndrome. Radiology. 2005 Aug;236(2):593-600. doi: 10.1148/radiol.2361040844. Epub 2005 Jun 21.
- Background: PubMed 12784422Ostergaard M, Peterfy C, Conaghan P, McQueen F, Bird P, Ejbjerg B, Shnier R, O'Connor P, Klarlund M, Emery P, Genant H, Lassere M, Edmonds J. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Core set of MRI acquisitions, joint pathology definitions, and the OMERACT RA-MRI scoring system. J Rheumatol. 2003 Jun;30(6):1385-6.
- Background: PubMed 17392347Haavardsholm EA, Ostergaard M, Ejbjerg BJ, Kvan NP, Kvien TK. Introduction of a novel magnetic resonance imaging tenosynovitis score for rheumatoid arthritis: reliability in a multireader longitudinal study. Ann Rheum Dis. 2007 Sep;66(9):1216-20. doi: 10.1136/ard.2006.068361. Epub 2007 Mar 28.
- Individual participant dataSharing planned: No. IPD will be used for PhD investigations. IPD will not be shared with other researchers
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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.
Tarek Carlos Salman, PhD contact
PAtricia corzo, MD principal investigator
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Hand Rheumatism and Systemic Lupus Erythematosus Arthritis, run by Hospital del Mar at 1 site in Spain.
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 5 inclusion and 7 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 31 Jul 2019. 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 Spain. 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. Some participants in this study may receive a placebo. 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 Patricia Corzo, MD (+34655057358, pcorzoreumatologia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI inflamatory changes (time frame: 1 to 2 months after clinical assesment). The study lists 6 primary outcomes in all. 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 NCT04035265, which also lists 6 linked publications.
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 31 Jul 2019.