Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
Primary Purpose
Rheumatoid Arthritis and Osteoarthritis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
serum calprotectin
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis and Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
RA patients
OA patients
Arm Description
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
Outcomes
Primary Outcome Measures
• 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
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04201886
Brief Title
Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
Official Title
Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis and Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RA patients
Arm Type
Other
Arm Description
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
Arm Title
OA patients
Arm Type
Other
Arm Description
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
Intervention Type
Other
Intervention Name(s)
serum calprotectin
Intervention Description
serum calcium binding leucocyte protein
Primary Outcome Measure Information:
Title
• Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients.
Description
Analysis of serum level of calprotectin in both Rheumatoid arthritis and Osteoarthritis patients as an indicator of disease activity
Time Frame
a year
Secondary Outcome Measure Information:
Title
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)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tayseer Mohammed Mahmoud, Prof.
Phone
01006061809
Email
dr.tayseeer@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Safaa Ali Gamal Al-din, Ass. Prof.
Phone
01003385106
Email
safaa69@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Hussien Abd El-Samea, Dr.
Organizational Affiliation
Assiut university hospitals
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
•Salehi Abari and Iraj. 2016 ACR revised criteria for early diagnosis of knee osteoarthritis. Autoimmune diseases and therapeutic approaches 2016; 3. 118.
Results Reference
background
PubMed Identifier
20872595
Citation
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.
Results Reference
result
PubMed Identifier
30229533
Citation
Copsey 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 Reference
result
PubMed Identifier
28832684
Citation
Hurnakova 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 Reference
result
PubMed Identifier
27832086
Citation
Hurnakova 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 Reference
result
PubMed Identifier
29656372
Citation
Hurnakova 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 Reference
result
PubMed Identifier
30560589
Citation
Douglas-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 Reference
result
PubMed Identifier
28814431
Citation
Jonsson 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 Reference
result
PubMed Identifier
29578196
Citation
Kumar 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 Reference
result
PubMed Identifier
30065453
Citation
Mansour 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 Reference
result
PubMed Identifier
27895095
Citation
Ometto 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 Reference
result
PubMed Identifier
6639693
Citation
Pincus 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.
Results Reference
result
PubMed Identifier
7818570
Citation
Prevoo 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.
Results Reference
result
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Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
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