Rheumatoid Arthritis Clinical Trial
— GADD34-RAOfficial title:
Quantification of GADD34 Expression in Rheumatoid Arthritis
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 3 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). Exclusion Criteria: - patients not fulfilling inclusion criteria - patients who receive treatments for other pathologies - persons protected by the law L1121-5 to L1121-8 of CSP (for example: pregnant women) |
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University Hospital, Grenoble |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | To verify the repeatability and reproducibility of GADD34 gene expression quantification by quantitative PCR. | GADD34 transcrit amplification in a sample from a healthy donor and a sample from a patient was measured 25 times in the same experiment in order to assess repeatability and in triplicate in each qPCR experiment (at least 7) in order to assess reproducibility. | 3 years | No |
Secondary | 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). | GADD34 gene expression level was quantified in the PBMC of the three groups of patients and compared between the three groups. | 3 years | No |
Secondary | GADD34 gene expression in synovial cells. | In patients treated with therapeutical arthrocentesis, to compare GADD34 gene expression level in synovial cells compared with its level in PBMC. | 3 years | No |
Secondary | GADD34 and cytokine production. | Quantification of Th1 and Th2 cytokines in RA patients serum by luminex technology. | 3 years | No |
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