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Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04201886
Recruitment Status : Not yet recruiting
First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa Nabil Badr, Assiut University

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis and Osteoarthritis Other: serum calprotectin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Serum Calprotectin Level in Patients With Rheumatoid Arthritis and Osteoarthritis
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
RA patients
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
Other: serum calprotectin
serum calcium binding leucocyte protein

OA patients
A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)
Other: serum calprotectin
serum calcium binding leucocyte protein




Primary Outcome Measures :
  1. • 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


Secondary Outcome Measures :
  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) [ Time Frame: a year ]
    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)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201886


Contacts
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Contact: Tayseer Mohammed Mahmoud, Prof. 01006061809 dr.tayseeer@hotmail.com
Contact: Safaa Ali Gamal Al-din, Ass. Prof. 01003385106 safaa69@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mona Hussien Abd El-Samea, Dr. Assiut university hospitals
Publications of Results:

Other Publications:
•Salehi Abari and Iraj. 2016 ACR revised criteria for early diagnosis of knee osteoarthritis. Autoimmune diseases and therapeutic approaches 2016; 3. 118.

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Responsible Party: Asmaa Nabil Badr, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04201886    
Other Study ID Numbers: calprotectin in RA and OA
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases