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Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04201886
Enrollment
80
Registered
2019-12-17
Start date
2020-01-31
Completion date
2021-10-31
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis and Osteoarthritis

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.

Interventions

serum calcium binding leucocyte protein

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
• Assessment of sensitivity and specificity of the serum calprotectin as an indicator of disease activity in both RA and OA patients.a yearAnalysis of serum level of calprotectin in both Rheumatoid arthritis and Osteoarthritis patients as an indicator of disease activity

Secondary

MeasureTime frameDescription
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 yearCompare 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)

Contacts

Primary ContactTayseer Mohammed Mahmoud, Prof.
dr.tayseeer@hotmail.com01006061809
Backup ContactSafaa Ali Gamal Al-din, Ass. Prof.
safaa69@yahoo.com01003385106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026