NCT04416997

Brief Summary

Rheumatoid arthritis is a chronic systemic inflammatory and autoimmune disease, characterized by disordered immunity, not regulated cytokines and inflammatory infiltration of the synovial joints. It is the most common inflammatory erosive poly arthritis affecting around 0.5-1% of the worldwide population which leads to joint damage and disability

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2.7 years

First QC Date

May 15, 2020

Last Update Submit

June 2, 2020

Conditions

Rheumatoid ArthritisSerum Albumin Low

Keywords

Rheumatoid arthritisRed blood cell distributionAlbumin

Outcome Measures

Primary Outcomes (2)

  • Assessment of level of Red blood cell distribution width

    Red blood cell distribution width will be measured.

    Through study completion, an average of 1 year

  • Assessment of level of serum Albumin in Rheumatoid arthritis patients

    The level of serum Albumin will be measured in Rheumatoid arthritis patients

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • The relation between Red blood cell distribution width and level of serum albumin in RA patients and association with the disease activity and severity.

    Through study completion, an average of 1 year

Study Arms (1)

Rheumatoid arthritis patients

Blood and serum samples

Procedure: Blood and serum samples

Interventions

Blood and serum samplesPROCEDURE

The blood and serum samples will taken from RA patients

Rheumatoid arthritis patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include adult RA patients consecutively presented at the Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals from both inpatient department and outpatient clinic.

You may qualify if:

  • Adult RA Patients who fulfilled the 2010 European league against rheumatism criteria for the classification of RA

You may not qualify if:

  • \. Patients with age less than 18 years 4. Patients with end stage organ failure.
  • \. Patients with liver diseases.
  • \. Patients with hematological disorders.
  • \. Patients with malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Asyut, 71515, Egypt

RECRUITING

Related Publications (3)

  • Alpizar-Rodriguez D, Finckh A. Environmental factors and hormones in the development of rheumatoid arthritis. Semin Immunopathol. 2017 Jun;39(4):461-468. doi: 10.1007/s00281-017-0624-2. Epub 2017 Apr 27.

    PMID: 28451785RESULT

  • 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. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461.

    PMID: 20699241RESULT

  • Yan F, Li H, Zhong Z, Zhou M, Lin Y, Tang C, Li C. Co-Delivery of Prednisolone and Curcumin in Human Serum Albumin Nanoparticles for Effective Treatment of Rheumatoid Arthritis. Int J Nanomedicine. 2019 Nov 22;14:9113-9125. doi: 10.2147/IJN.S219413. eCollection 2019.

    PMID: 31819422RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and serum samples

MeSH Terms

Conditions

Arthritis, RheumatoidHypoalbuminemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesHypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Fatma Meligy, Dr

    FYMeligy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princible investigator

Study Record Dates

First Submitted

May 15, 2020

First Posted

June 4, 2020

Study Start

March 1, 2020

Primary Completion

October 29, 2022

Study Completion

January 30, 2023

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

study the relation between RDW and level of serum albumin in RA patients and association with the disease activity and severity.

Locations

EG(1)