NFKB1 and IKK Epsilon in Rheumatoid Arthritis

NCT02689115 | Completed

• 1 other identifier: 2015/02
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rheumatoid arthritis (RA) is a systemic and auto-immune disorder whose primary characteristic is the chronic inflammation of joints. The objective of this study was to evaluate whether there was an association between the NF-KB1/IKK epsilon genetic expression and the clinical activity in RA. 60 RA patients were included in the study, 30 with clinical activity and 30 with clinical remission The NF-KB1/IKK epsilon genetic expression was performed by real time quantitative Polymerase chain reaction (qPCR) through the Pfaffl method of relative quantification with Taqman probes.

Conditions

Rheumatoid Arthritis

Keywords

Nuclear factor Kappa B; IKK epsilon

Outcome Measures

Primary Outcomes (1)

• Relative genetic expression of NF-KB1 and IKK epsilon.

  Within one month after the patient selection.

Study Arms (2)

Clinical activity

Patients with rheumatoid arthritis who met the criteria established by the American College of RheumatologyDisease Activity Score 28 (DAS28) \> 3.6.

Other: Genetic relative expression

Clinical remission

Patients with rheumatoid arthritis with Disease Activity Score 28 (DAS28) \< 2.4.

Other: Genetic relative expression

Interventions

Genetic relative expression OTHER

The genetic expression of NF-KB1 and IKK epsilon were quantified in both groups.

Clinical activity; Clinical remission

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The key inclusion criteria were patients with RA who met the criteria established by the American College of Rheumatology (ACR). Two groups were conformed based on the Disease Activity Score 28 (DAS28): a) with clinical activity (DAS28 \> 3.6) and b) with clinical remission (DAS28 \< 2.4). Key exclusion criteria were patients with any other inflammatory, autoimmune or neoplastic disease and patients with infections. The control group was represented by healthy patients

You may qualify if:

• Diagnosis criteria established by the American College of Rheumatology (ACR).

You may not qualify if:

• Patients with any other inflammatory, autoimmune or neoplastic disease and patients with infections.

Sponsors & Collaborators

• Asociación Científica Latina A.C.: lead
• Universidad Autonoma del Estado de Mexico: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hugo Mendieta Zerón, PhD.

  Asociación Científica Latina A.C.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 23, 2016
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02