NCT04201886

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

December 14, 2019

Last Update Submit

December 16, 2019

Conditions

Rheumatoid Arthritis and Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • • 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 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)

    a year

Study Arms (2)

RA patients

OTHER

A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)

Other: serum calprotectin

OA patients

OTHER

A. Full history taking B. Physical examination C. Laboratory investigation: • Serum Calprotectin (CLP)

Other: serum calprotectin

Interventions

serum calprotectinOTHER

serum calcium binding leucocyte protein

OA patientsRA patients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

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

    BACKGROUND

  • 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.

    PMID: 20872595RESULT

  • 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.

    PMID: 30229533RESULT

  • 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.

    PMID: 28832684RESULT

  • 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.

    PMID: 27832086RESULT

  • 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.

    PMID: 29656372RESULT

  • 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.

    PMID: 30560589RESULT

  • 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.

    PMID: 28814431RESULT

  • 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.

    PMID: 29578196RESULT

  • 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.

    PMID: 30065453RESULT

  • 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.

    PMID: 27895095RESULT

  • 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.

    PMID: 6639693RESULT

  • 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.

    PMID: 7818570RESULT

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mona Hussien Abd El-Samea, Dr.

    Assiut university hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tayseer Mohammed Mahmoud, Prof.

CONTACT

01006061809dr.tayseeer@hotmail.com

Safaa Ali Gamal Al-din, Ass. Prof.

CONTACT

01003385106safaa69@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

December 14, 2019

First Posted

December 17, 2019

Study Start

January 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

December 17, 2019

Record last verified: 2019-12