Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy

NCT01299545 | Terminated

• 1 other identifier: 2010-A01046-33
• Study Type: observational
• Target: 123
• Locations: 8 countries
• Sites: 37

Brief Summary

Study Design \& Objectives: Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks. To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria. Ancillary study objective: To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Anti TNF; Infliximab; Methotrexate; DMARDs; Gene expression biomarkers

Outcome Measures

Primary Outcomes (1)

• To determine the performances of the RA-INF-Dx test to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.

  Statistical relationship between the RA-INF-Dx blood test results and the non-response (evaluated according to EULAR criteria) to infliximab and methotrexate combination therapy will be analyzed.

  Performed at inclusion : blood samples will be taken before the infliximab infusion.

Secondary Outcomes (1)

• Non-response to infliximab and methotrexate combination therapy based on American College of Rheumatology (ACR) criteria

  at the time of the first response evaluation (between the 12th and the 14th week)

Study Arms (1)

a single group of patients -200 expected

polyarthrite rhumatoid patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from RA eligible to a first biologic therapy for whom the treating rheumatologist envisages infliximab therapy will be included in this study.

You may qualify if:

• Diagnosis of Rheumatoid Arthritis
• Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.
• Disease Activity
• Patient with a DAS28 greater than 3.2.
• Treatment
• Patient eligible for a first line TNFα blocking agent treatment with infliximab according to the "Summary of Product Characteristics",
• Patient refractory to treatment with at least one classical DMARDs (one of which has to be MTX) prescribed according to the international recommendations, i.e. for at least 12 weeks at the maximal tolerated dose prior to infliximab treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy (patients may be included if they have undergone a wash-out period using cholestyramine or equivalent subsequent to leflunomide treatment),
• Use of oral steroids (≤ 10mg/day of prednisone or equivalent dose of another molecule) and/or NSAIDs will be permitted; doses must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy,
• Other criteria
• Negative β-HCG pregnancy test, when appropriate according to the patient's age and contraceptive method,
• Informed consent signed.

You may not qualify if:

• Patient having received previous courses of other biologic therapy (TNF blocking agents, anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development),
• Patient non eligible to infliximab therapy according to the "Summary of Product Characteristics",
• Patient with clinically significant, severe and uncontrolled infectious diseases,
• Patient with symptoms of a significant somatic or psychiatric/mental illness,
• Patient with other auto-immune diseases (i.e. Inflammatory Bowel Diseases, Systemic Lupus Erythematosus, vasculitis, uncontrolled asthma, etc...),
• Patient with evidence of cardiac, pulmonary, metabolic, renal, hepatic, gastro-intestinal conditions, which, in the opinion of the investigator, may interfere with the study,
• Pregnancy,
• Patient that is participating in a clinical trial or that participated in a previous one within 10 weeks prior to study entry.

Sponsors & Collaborators

• TcLand Expression S.A.: lead
• Premier Research: collaborator
• Theradis pharma: collaborator
• Medpharmgene, Inc.: collaborator

Study Sites (37)

Location n°31

Mississauga - Chow, Canada

Location

Location n°36

Ontario, Canada

Location

Location n°34

Rimouski, Canada

Location

Location n°33

Saskatchewan, Canada

Location

Location n°35

Toronto, Canada

Location

Location n°41

Amiens, France

Location

Location n°13

Bobigny, France

Location

Location n°39

Dreux, France

Location

Location n°14

Grenoble, France

Location

Location n°40

Meaux, France

Location

Location n°25

Paris, France

Location

Location n°37

Paris (Hop Bichat), France

Location

Location n°38

Strasbourg, France

Location

Location n°6

Budapest, Hungary

Location

Location n°8

Budapest, Hungary

Location

Location n°7

Debrecen, Hungary

Location

Location n°10

Eger, Hungary

Location

Location n°9

Kistarcsa, Hungary

Location

Location n°15

Messina, Italy

Location

Location n°16

Milan, Italy

Location

Location n°17

Pisa, Italy

Location

Location n°27

Kaunas, Lithuania

Location

Location n°29

Klaipėda, Lithuania

Location

Location n°30

Panevezys, Lithuania

Location

Location n°28

Vilnius, Lithuania

Location

Location n° 19

Bucharest, Romania

Location

Location n°20

Bucharest, Romania

Location

Location n°22

Bucharest, Romania

Location

Location n°23

Bucharest, Romania

Location

Location n°21

Cluj-Napoca, Romania

Location

Location n°24

Iași, Romania

Location

Location n°26

Iași, Romania

Location

Location n°18

Timișoara, Romania

Location

Location n°12

Banská Bystrica, Slovakia

Location

Location n°11

Piešťany, Slovakia

Location

Location n°3

Málaga, Spain

Location

Location n°5

Oviedo, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sampling in Paxgene tubes (DNA, RNA) Whole blood sampling in EDTA tubes

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sara MARSAL, MD

  University Hospital Val d'Hebron (Barcelona, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

FR (8); ES (2); HU (5); CA (5); SL (2); LI (4); RO (8); IT (3)