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CompletedNCT00213538Updated Jun 14, 2017

Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

An observational study in Rheumatoid Arthritis, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
341
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 341 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who Satisfied the 1987 American College of Rheumatology revised criteria for Rheumatoid arthritis

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
341 participants (actual)
Patient registry
No

Interventions

  • DrugResponse to anakinra associated with methotrexate
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What researchers measure

Primary outcomes

  1. Auto-antibody level

    Time frame: One year

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Study locations

1 site
  • CHU de rouen - Hôpitaux de Rouen
    Rouen, 76031, France
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References and documents

Publications

  • Bansard C, Lequerre T, Derambure C, Vittecoq O, Hiron M, Daragon A, Pouplin S, Daveau M, Boyer O, Tron F, Le Loet X, Salier JP. Gene profiling predicts rheumatoid arthritis responsiveness to IL-1Ra (anakinra). Rheumatology (Oxford). 2011 Feb;50(2):283-92. doi: 10.1093/rheumatology/keq344. Epub 2010 Nov 8. PubMed 21059672 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00213538
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Jun 2003
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jun 14, 2017

Study contacts

Xavier Le Loët
principal investigator · Rouen University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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