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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213538
First received: September 13, 2005
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Response to anakinra associated with methotrexate
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Study Start Date: June 2003
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213538

Contacts
Contact: xavier Le louet, MD 0232888265 xavier.le-loet@chu-rouen.fr

Locations
France
CHU de rouen - Hôpitaux de Rouen Recruiting
Rouen, France, 76031
Contact: Xavier Le Loët, MD    33 2 32 88 90 19    xavier.le-loet@chu-rouen.fr   
Sub-Investigator: Jean-Philippe Salier, PhD         
Sub-Investigator: Maryvonne Daveau, MDPhD         
Sub-Investigator: Thierry Lequerré, MD         
Sub-Investigator: François TRON, MDPhD         
Sub-Investigator: Olivier Vittecoq, MDPhD         
Sub-Investigator: Alain DARAGON, MD         
Sub-Investigator: Othmane Mejjad, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Xavier Le Loët Rouen University Hospital
  More Information

No publications provided by University Hospital, Rouen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213538     History of Changes
Other Study ID Numbers: 2003/020/HP
Study First Received: September 13, 2005
Last Updated: January 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014