Quantification of GADD34 Expression in RA

NCT02401165 | Completed

• 1 other identifier: 2012-A01416-37
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

GADD34 is an inducible cofactor of protein phosphatase 1, which has an important role in the Unfolded Protein Response (UPR). UPR is a cellular response to ER stress which is implicated in several autoimmune diseases. GADD34 has been shown to be necessary for proinflammatory cytokine production in response to viral infection in murine models. Nevertheless, the role of GADD34 in cytokine production in humans remains to be elucidated. Here, we investigate the interest of GADD34 in rheumatoid arthritis (RA), in which proinflammatory cytokines have an important pathogenic role. A case-control study on GADD34 gene expression in PBMC of patients (n=75) with RA and age- and sex-matched healthy controls (n=25). GADD34 gene expression levels in PBMC were measured by quantitative PCR.

Conditions

Rheumatoid Arthritis

Keywords

GADD34; Unfolded Protein Response; Anti-citrullinated protein antibodies

Outcome Measures

Primary Outcomes (1)

• To determine if GADD34 gene expression level in the PBMC of rheumatoid arthritis patients is increased compared to its expression in the PBMC of healthy controls.

  GADD34 gene expression level is quantified in the PBMC by quantitative PCR.

  3 years

Secondary Outcomes (4)

• To verify the repeatability and reproducibility of GADD34 gene expression quantification by quantitative PCR.

  3 years

• To compare GADD34 gene expression level in the PBMC of 3 groups of patients: patients with DAS28<2.6 (low RA activity), DAS28>2.6 and <5.1 (intermediate RA activity), DAS28>5.1 (high RA activity).

  3 years

• GADD34 gene expression in synovial cells.

  3 years

• GADD34 and cytokine production.

  3 years

Study Arms (1)

patient

OTHER

patient

Other: Blood test

Interventions

Blood test OTHER

blood test

patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with rheumatoid arthritis fulfilling the American College of Rheumatology 1987 revised criteria for the classification of RA
• age between 18 and 75
• patients benefiting of social security
• Informed consent signed by the patients
• groups of patients were included: patients with DAS28\<2.6 (n=25); patients with DAS28\>2.6 and\<5.1 (n=25): patients with DAS28\>5.1 (n=25).

You may not qualify if:

• patients who receive treatments for other pathologies
• persons protected by the law L1121-5 to L1121-8 of CSP (for example: pregnant women)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Related Publications (1)

• Clavarino G, Adriouach S, Quesada JL, Clay M, Chevreau M, Trocme C, Grange L, Gaudin P, Gatti E, Pierre P, Cesbron JY, Dumestre-Perard C. Unfolded protein response gene GADD34 is overexpressed in rheumatoid arthritis and related to the presence of circulating anti-citrullinated protein antibodies. Autoimmunity. 2016;49(3):172-8. doi: 10.3109/08916934.2016.1138220. Epub 2016 Feb 1.

  PMID: 26829377 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 27, 2015

Record last verified: 2015-03