Rheumatoid Arthritis and OsteoarthritisPhase 4NCT04201886
Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
A Phase 4 study testing serum calprotectin in people with Rheumatoid Arthritis and Osteoarthritis, run by Assiut University.
Trial summary
Assessment of the serum level of calprotectin in patients with rheumatoid arthritis and osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rheumatoid Arthritis and Osteoarthritis
- What is being tested?
- serum calprotectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Oct 2021
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA
- Adult osteoarthritis patients who fulfilled 2016 ACR revised Criteria for early diagnosis of knee OA
Who cannot join
- Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis, behcet's disease, psoriasis and inflammatory bowel disease).
- RA patients with interstitial lung disease (IPF).
- Patients with malignancy.
- Patients with end stage organ failure.
- Other conditions that may affect the serum level of calprotectin as diabetes mellitus, coronary artery disease, hepatitis and concomitant inflammatory disease as acute infection or chronic inflammatory status.
Trial locations and contacts
No sites are listed yet.
About this study
Assessment of the serum level of calprotectin in patients with rheumatoid arthritis and osteoarthritis.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with genetic susceptibility. It is characterized by chronic synovitis and progressive joint destruction. There is synovial infiltration by inflammatory cells, activation of synovial fibroblasts, and production of a wide range of inflammatory cytokines. Sustained high disease activity results in a poor disease outcome so assessment of inflammatory activity in RA is of pivotal importance for the optimal treatment in these patients. Disease activity of RA patients is assessed by clinical examination, laboratory tests and radiographic assessment (e.g. ultrasonography). Laboratory assessment of RA activity is done routinely by measuring acute phase reactants such as an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), which are elevated in most patients with RA. It has been demonstrated that more than 40% of RA patients have normal ESR or CRP (false negative results). Therefore, new serum markers that can more accurately reflect real inflammatory activity in RA patients are needed. Calprotectin (CLP) is a calcium binding leucocyte protein consisting of the heterocomplex of S100A8/ A9 (myeloid-related protein, MRP8/MRP14), as well as being a major monocyte/macrophage protein which has gained interest as a marker of inflammation in RA. Calprotectin has been identified as an important endogenous alarmin, one of the damage-associated molecular pattern (DAMP) molecules that acts as a ligand for the TLR4 receptor and amplifies the inflammation cascade via NF-kB and p38 mitogen-activated protein kinase. Calprotectin levels are higher in the serum of RA patients compared with healthy subjects or patients with osteoarthritis (OA), Still, no cut-off levels have been identified to help in the diagnosis of RA. Calprotectin is involved in cartilage damage in OA. Synovial lining macrophages play a role in the OA process and in cartilage damage. Moderate calprotectin increase has been observed in the serum of OA patients compared with healthy controls also serum calprotectin levels were found higher in OA patients with synovial inflammation compared with those without.
- Conditions
- Rheumatoid Arthritis and Osteoarthritis
- Being tested
- serum calprotectin
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum calprotectinOther
serum calcium binding leucocyte protein
| Study group | Role | What they receive |
|---|---|---|
| RA patients | Other | A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP) Receives: Other: serum calprotectin |
| OA patients | Other | A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP) Receives: Other: serum calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients.
Analysis of serum level of calprotectin in both Rheumatoid arthritis and Osteoarthritis patients as an indicator of disease activity
Measured: a year
Secondary outcomes (1)
Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study startJan 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis and OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nabil Badr, Assiut University
- Investigators
- Mona Hussien Abd El-Samea, Dr., Principal investigator, Assiut university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201886
- Sponsor's protocol ID
- calprotectin in RA and OA
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
•Salehi Abari and Iraj. 2016 ACR revised criteria for early diagnosis of knee osteoarthritis. Autoimmune diseases and therapeutic approaches 2016; 3. 118.
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
PubMed 20872595Copsey B, Thompson JY, Vadher K, Ali U, Dutton SJ, Fitzpatrick R, Lamb SE, Cook JA. Problems persist in reporting of methods and results for the WOMAC measure in hip and knee osteoarthritis trials. Qual Life Res. 2019 Feb;28(2):335-343. doi: 10.1007/s11136-018-1978-1. Epub 2018 Sep 18.
PubMed 30229533Hurnakova J, Hulejova H, Zavada J, Hanova P, Komarc M, Mann H, Klein M, Sleglova O, Olejarova M, Forejtova S, Ruzickova O, Vencovsky J, Pavelka K, Senolt L. Relationship between serum calprotectin (S100A8/9) and clinical, laboratory and ultrasound parameters of disease activity in rheumatoid arthritis: A large cohort study. PLoS One. 2017 Aug 23;12(8):e0183420. doi: 10.1371/journal.pone.0183420. eCollection 2017.
PubMed 28832684Hurnakova J, Hulejova H, Zavada J, Komarc M, Hanova P, Klein M, Mann H, Sleglova O, Olejarova M, Forejtova S, Ruzickova O, Vencovsky J, Pavelka K, Senolt L. Serum Calprotectin Discriminates Subclinical Disease Activity from Ultrasound-Defined Remission in Patients with Rheumatoid Arthritis in Clinical Remission. PLoS One. 2016 Nov 10;11(11):e0165498. doi: 10.1371/journal.pone.0165498. eCollection 2016.
PubMed 27832086Hurnakova J, Hulejova H, Zavada J, Komarc M, Cerezo LA, Mann H, Vencovsky J, Pavelka K, Senolt L. Serum calprotectin may reflect inflammatory activity in patients with active rheumatoid arthritis despite normal to low C-reactive protein. Clin Rheumatol. 2018 Aug;37(8):2055-2062. doi: 10.1007/s10067-018-4091-5. Epub 2018 Apr 14.
PubMed 29656372Douglas-Withers J, McCulloch K, Waters D, Parker K, Hogg N, Mitsuhashi T, Treharne GJ, Abbott JH, Stebbings S. Associations between Health Assessment Questionnaire Disability Index and physical performance in rheumatoid arthritis and osteoarthritis. Int J Rheum Dis. 2019 Mar;22(3):417-424. doi: 10.1111/1756-185X.13460. Epub 2018 Dec 17.
PubMed 30560589Jonsson MK, Sundlisaeter NP, Nordal HH, Hammer HB, Aga AB, Olsen IC, Brokstad KA, van der Heijde D, Kvien TK, Fevang BS, Lillegraven S, Haavardsholm EA. Calprotectin as a marker of inflammation in patients with early rheumatoid arthritis. Ann Rheum Dis. 2017 Dec;76(12):2031-2037. doi: 10.1136/annrheumdis-2017-211695. Epub 2017 Aug 16.
PubMed 28814431Kumar BS, Suneetha P, Mohan A, Kumar DP, Sarma KVS. Comparison of Disease Activity Score in 28 joints with ESR (DAS28), Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire Disability Index (HAQ-DI) & Routine Assessment of Patient Index Data with 3 measures (RAPID3) for assessing disease activity in patients with rheumatoid arthritis at initial presentation. Indian J Med Res. 2017 Nov;146(Supplement):S57-S62. doi: 10.4103/ijmr.IJMR_701_15.
PubMed 29578196Mansour HE, Abdullrhman MA, Mobasher SA, El Mallah R, Abaza N, Hamed F, Khalil AAF. Serum Calprotectin in Rheumatoid Arthritis: A Promising Diagnostic Marker, How Far Is It Related to Activity and Sonographic Findings? J Med Ultrasound. 2017 Jan-Mar;25(1):40-46. doi: 10.1016/j.jmu.2016.11.001. Epub 2017 Jan 3.
PubMed 30065453Ometto F, Friso L, Astorri D, Botsios C, Raffeiner B, Punzi L, Doria A. Calprotectin in rheumatic diseases. Exp Biol Med (Maywood). 2017 Apr;242(8):859-873. doi: 10.1177/1535370216681551. Epub 2016 Jan 1.
PubMed 27895095Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983 Nov;26(11):1346-53. doi: 10.1002/art.1780261107.
PubMed 6639693Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.
PubMed 7818570
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
- ClinicalTrials.gov ID
- NCT04201886
- Acronym / sponsor ID
- calprotectin in RA and OA
- Conditions
- Rheumatoid Arthritis and Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 17 Dec 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.
Assessment of the serum level of calprotectin in patients with rheumatoid arthritis and osteoarthritis.
Detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with genetic susceptibility. It is characterized by chronic synovitis and progressive joint destruction. There is synovial infiltration by inflammatory cells, activation of synovial fibroblasts, and production of a wide range of inflammatory cytokines. Sustained high disease activity results in a poor disease outcome so assessment of inflammatory activity in RA is of pivotal importance for the optimal treatment in these patients. Disease activity of RA patients is assessed by clinical examination, laboratory tests and radiographic assessment (e.g. ultrasonography). Laboratory assessment of RA activity is done routinely by measuring acute phase reactants such as an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), which are elevated in most patients with RA. It has been demonstrated that more than 40% of RA patients have normal ESR or CRP (false negative results). Therefore, new serum markers that can more accurately reflect real inflammatory activity in RA patients are needed. Calprotectin (CLP) is a calcium binding leucocyte protein consisting of the heterocomplex of S100A8/ A9 (myeloid-related protein, MRP8/MRP14), as well as being a major monocyte/macrophage protein which has gained interest as a marker of inflammation in RA. Calprotectin has been identified as an important endogenous alarmin, one of the damage-associated molecular pattern (DAMP) molecules that acts as a ligand for the TLR4 receptor and amplifies the inflammation cascade via NF-kB and p38 mitogen-activated protein kinase. Calprotectin levels are higher in the serum of RA patients compared with healthy subjects or patients with osteoarthritis (OA), Still, no cut-off levels have been identified to help in the diagnosis of RA. Calprotectin is involved in cartilage damage in OA. Synovial lining macrophages play a role in the OA process and in cartilage damage. Moderate calprotectin increase has been observed in the serum of OA patients compared with healthy controls also serum calprotectin levels were found higher in OA patients with synovial inflammation compared with those without.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients | Other | Other: serum calprotectinA. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP) |
| OA patients | Other | Other: serum calprotectinA. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA
- Adult osteoarthritis patients who fulfilled 2016 ACR revised Criteria for early diagnosis of knee OA
Key exclusion criteria (5 listed)
- Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis, behcet's disease, psoriasis and inflammatory bowel disease).
- RA patients with interstitial lung disease (IPF).
- Patients with malignancy.
- Patients with end stage organ failure.
- Other conditions that may affect the serum level of calprotectin as diabetes mellitus, coronary artery disease, hepatitis and concomitant inflammatory disease as acute infection or chronic inflammatory status.
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 |
|---|---|---|
| serum calprotectinserum calcium binding leucocyte protein | Other | OA patients, RA patients |
Primary outcome
• Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients.
Time frame: a year
Analysis of serum level of calprotectin in both Rheumatoid arthritis and Osteoarthritis patients as an indicator of disease activity
1 secondary outcome
Compare between sensitivity and specificity of the serum calprotectin in detecting the activity of disease in both RA (Autoimmune inflammatory disease) and OA (Degenerative inflammatory disease)
Time frame: a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background•Salehi Abari and Iraj. 2016 ACR revised criteria for early diagnosis of knee osteoarthritis. Autoimmune diseases and therapeutic approaches 2016; 3. 118.
- Results publication: PubMed 20872595Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
- Results publication: PubMed 30229533Copsey B, Thompson JY, Vadher K, Ali U, Dutton SJ, Fitzpatrick R, Lamb SE, Cook JA. Problems persist in reporting of methods and results for the WOMAC measure in hip and knee osteoarthritis trials. Qual Life Res. 2019 Feb;28(2):335-343. doi: 10.1007/s11136-018-1978-1. Epub 2018 Sep 18.
- Results publication: PubMed 28832684Hurnakova J, Hulejova H, Zavada J, Hanova P, Komarc M, Mann H, Klein M, Sleglova O, Olejarova M, Forejtova S, Ruzickova O, Vencovsky J, Pavelka K, Senolt L. Relationship between serum calprotectin (S100A8/9) and clinical, laboratory and ultrasound parameters of disease activity in rheumatoid arthritis: A large cohort study. PLoS One. 2017 Aug 23;12(8):e0183420. doi: 10.1371/journal.pone.0183420. eCollection 2017.
- Results publication: PubMed 27832086Hurnakova J, Hulejova H, Zavada J, Komarc M, Hanova P, Klein M, Mann H, Sleglova O, Olejarova M, Forejtova S, Ruzickova O, Vencovsky J, Pavelka K, Senolt L. Serum Calprotectin Discriminates Subclinical Disease Activity from Ultrasound-Defined Remission in Patients with Rheumatoid Arthritis in Clinical Remission. PLoS One. 2016 Nov 10;11(11):e0165498. doi: 10.1371/journal.pone.0165498. eCollection 2016.
- Results publication: PubMed 29656372Hurnakova J, Hulejova H, Zavada J, Komarc M, Cerezo LA, Mann H, Vencovsky J, Pavelka K, Senolt L. Serum calprotectin may reflect inflammatory activity in patients with active rheumatoid arthritis despite normal to low C-reactive protein. Clin Rheumatol. 2018 Aug;37(8):2055-2062. doi: 10.1007/s10067-018-4091-5. Epub 2018 Apr 14.
- Results publication: PubMed 30560589Douglas-Withers J, McCulloch K, Waters D, Parker K, Hogg N, Mitsuhashi T, Treharne GJ, Abbott JH, Stebbings S. Associations between Health Assessment Questionnaire Disability Index and physical performance in rheumatoid arthritis and osteoarthritis. Int J Rheum Dis. 2019 Mar;22(3):417-424. doi: 10.1111/1756-185X.13460. Epub 2018 Dec 17.
- Results publication: PubMed 28814431Jonsson MK, Sundlisaeter NP, Nordal HH, Hammer HB, Aga AB, Olsen IC, Brokstad KA, van der Heijde D, Kvien TK, Fevang BS, Lillegraven S, Haavardsholm EA. Calprotectin as a marker of inflammation in patients with early rheumatoid arthritis. Ann Rheum Dis. 2017 Dec;76(12):2031-2037. doi: 10.1136/annrheumdis-2017-211695. Epub 2017 Aug 16.
- Results publication: PubMed 29578196Kumar BS, Suneetha P, Mohan A, Kumar DP, Sarma KVS. Comparison of Disease Activity Score in 28 joints with ESR (DAS28), Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire Disability Index (HAQ-DI) & Routine Assessment of Patient Index Data with 3 measures (RAPID3) for assessing disease activity in patients with rheumatoid arthritis at initial presentation. Indian J Med Res. 2017 Nov;146(Supplement):S57-S62. doi: 10.4103/ijmr.IJMR_701_15.
- Results publication: PubMed 30065453Mansour HE, Abdullrhman MA, Mobasher SA, El Mallah R, Abaza N, Hamed F, Khalil AAF. Serum Calprotectin in Rheumatoid Arthritis: A Promising Diagnostic Marker, How Far Is It Related to Activity and Sonographic Findings? J Med Ultrasound. 2017 Jan-Mar;25(1):40-46. doi: 10.1016/j.jmu.2016.11.001. Epub 2017 Jan 3.
- Results publication: PubMed 27895095Ometto F, Friso L, Astorri D, Botsios C, Raffeiner B, Punzi L, Doria A. Calprotectin in rheumatic diseases. Exp Biol Med (Maywood). 2017 Apr;242(8):859-873. doi: 10.1177/1535370216681551. Epub 2016 Jan 1.
- Results publication: PubMed 6639693Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983 Nov;26(11):1346-53. doi: 10.1002/art.1780261107.
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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.
Mona Hussien Abd El-Samea, Dr. principal investigator
Assiut university hospitals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing serum calprotectin in people with Rheumatoid Arthritis and Osteoarthritis, run by Assiut 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 2 inclusion and 5 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 17 Dec 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tayseer Mohammed Mahmoud, Prof. (01006061809, dr.tayseeer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients. (time frame: a 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 NCT04201886, which also lists 13 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 17 Dec 2019.