Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

Rheumatoid Arthritis and Osteoarthritis Clinical Trial

Official title:

Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04201886
• Other study ID #: calprotectin in RA and OA
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2020
• Est. completion date: October 2021

Study information

• Verified date: December 2019
• Source: Assiut University
• Contact: Tayseer Mohammed Mahmoud, Prof.
• Phone: 01006061809
• Email: dr.tayseeer[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of the serum level of calprotectin in patients with rheumatoid arthritis and osteoarthritis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Adult RA Patients who fulfilled the 2010 ACR/European league against rheumatism (EULAR) criteria for the classification of RA

2. Adult osteoarthritis patients who fulfilled 2016 ACR revised Criteria for early diagnosis of knee OA

Exclusion Criteria:

1. Individuals with other autoimmune diseases (systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, scleroderma, spondyloarthritis, behcet's disease, psoriasis and inflammatory bowel disease).

2. RA patients with interstitial lung disease (IPF).

3. Patients with malignancy.

4. Patients with end stage organ failure.

5. 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis and Osteoarthritis

Intervention

Other:
• serum calprotectin
serum calcium binding leucocyte protein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

•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 — View 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/s1113 — View 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 — View 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 paramet — View 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. 2 — View 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 — View Citation

Jonsson MK, Sundlisæter 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. 20 — View 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 — View 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) — View 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. Review. — View 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. — View 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 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	a year
Secondary	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)	a year