Rheumatoid Arthritis Clinical Trial
Official title:
Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis
Verified date | June 2017 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of the study is to identify and validate predictive markers of anakinra
responsiveness in RA patients by a transcriptomic approach.
Patients with active RA (ACR criteria) were given subcutaneous anakinra (100mg/d) 3
associated with metotrexate. Anakinra efficacy was evaluated at week 12, using the EULAR
response criteria.
A blood sample was collected just before the onset of anakinra treatment and total RNAs were
extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled mRNAs were
hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a
high density on nylon membranes. Data were normalized and filtered to allow the comparison
between RNA samples. Statistical analyses were performed with the R software and
hierarchical clustering was performed with the Cluster and Tree View softwares.
Status | Completed |
Enrollment | 341 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Is age 18 years old or older Satisfies the 1987 American College of Rheumatology revised criteria for Rheumatoid arthritis Has active disease at the time of randomization as indicated by a DAS28> 5.1 Has a disease at least refractory to DMARDs whose methotrexate or leflunomide Is capable of understanding and signing an informed consent form Agrees to use a medically accepted form of contraception during the study Exclusion Criteria: - Is pregnant or breast-feeding or without contraception Has significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the study, uncompensated congestive heart failure, significant active infection or any underlying diseases that could predispose subjects to infections (whose tuberculosis) Has renal disease (creatinin clearance level < 30 ml/min) Has allergy to anakinra Has leukopenia (white blood cells < 1.5 x 109 /l |
Country | Name | City | State |
---|---|---|---|
France | CHU de rouen - Hôpitaux de Rouen | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Auto-antibody level | One year |
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