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

NCT ID: NCT01299545

Last Updated: 2013-02-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-10-31

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.

Detailed Description

The RA-INF-Dx test is a non invasive in vitro blood test intended to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.

The RA-INF-Dx test is indicated for use in patients:

• 18 years of age or older,
• Eligible for a first line biologic therapy with infliximab. The RA-INF-Dx test is indicated for use by rheumatologists as a biological basis for guiding infliximab treatment prior to its initiation.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

a single group of patients -200 expected

polyarthrite rhumatoid patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Diagnosis of Rheumatoid Arthritis

1. Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.

Disease Activity

2. Patient with a DAS28 greater than 3.2.

Treatment

3. Patient eligible for a first line TNFα blocking agent treatment with infliximab according to the "Summary of Product Characteristics",

4. 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),

5. 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

6. Patient (male or female) at 18 years of age or older at inclusion,

7. Negative β-HCG pregnancy test, when appropriate according to the patient's age and contraceptive method,

8. Informed consent signed.

Exclusion Criteria

1. 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),

2. Patient non eligible to infliximab therapy according to the "Summary of Product Characteristics",

3. Patient with clinically significant, severe and uncontrolled infectious diseases,

4. Patient with symptoms of a significant somatic or psychiatric/mental illness,

5. Patient with other auto-immune diseases (i.e. Inflammatory Bowel Diseases, Systemic Lupus Erythematosus, vasculitis, uncontrolled asthma, etc...),

6. Patient with evidence of cardiac, pulmonary, metabolic, renal, hepatic, gastro-intestinal conditions, which, in the opinion of the investigator, may interfere with the study,

7. Pregnancy,

8. Patient that is participating in a clinical trial or that participated in a previous one within 10 weeks prior to study entry.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Premier Research Group plc

UNKNOWN

Sponsor Role: collaborator

Theradis pharma

UNKNOWN

Sponsor Role: collaborator

Medpharmgene, Inc.

INDUSTRY

Sponsor Role: collaborator

TcLand Expression S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara MARSAL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Val d'Hebron (Barcelona, Spain)

Locations

Location n°31

Mississauga - Chow, , Canada

Location n°36

Ontario, , Canada

Location n°34

Rimouski, , Canada

Location n°33

Saskatchewan, , Canada

Location n°35

Toronto, , Canada

Location n°41

Amiens, , France

Location n°13

Bobigny, , France

Location n°39

Dreux, , France

Location n°14

Grenoble, , France

Location n°40

Meaux, , France

Location n°25

Paris, , France

Location n°37

Paris (Hop Bichat), , France

Location n°38

Strasbourg, , France

Location n°6

Budapest, , Hungary

Location n°8

Budapest, , Hungary

Location n°7

Debrecen, , Hungary

Location n°10

Eger, , Hungary

Location n°9

Kistarcsa, , Hungary

Location n°15

Messina, , Italy

Location n°16

Milan, , Italy

Location n°17

Pisa, , Italy

Location n°27

Kaunas, , Lithuania

Location n°29

Klaipėda, , Lithuania

Location n°30

Panevezys, , Lithuania

Location n°28

Vilnius, , Lithuania

Location n° 19

Bucharest, , Romania

Location n°20

Bucharest, , Romania

Location n°22

Bucharest, , Romania

Location n°23

Bucharest, , Romania

Location n°21

Cluj-Napoca, , Romania

Location n°24

Iași, , Romania

Location n°26

Iași, , Romania

Location n°18

Timișoara, , Romania

Location n°12

Banská Bystrica, , Slovakia

Location n°11

Piešťany, , Slovakia

Location n°3

Málaga, , Spain

Location n°5

Oviedo, , Spain

Countries

Canada; France; Hungary; Italy; Lithuania; Romania; Slovakia; Spain

Other Identifiers

2010-A01046-33

Identifier Type: -

Identifier Source: org_study_id