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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213538
• Other study ID #: 2003/020/HP
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 13, 2017
• Start date: June 2003
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Response to anakinra associated with methotrexate

Locations

Country	Name	City	State
France	CHU de rouen - Hôpitaux de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auto-antibody level		One year