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

Rheumatoid Arthritis Clinical Trial

— PRINT  

Official title:

Validation Study of RA-INF-Dx as a Multigene Molecular 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01299545
• Other study ID #: 2010-A01046-33
• Status: Terminated
• Phase: N/A
• First received: February 16, 2011
• Last updated: January 31, 2013
• Start date: February 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: TcLand Expression S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyHungary: Scientific and Medical Research Council Ethics CommitteeSlovakia: State Institute for Drug ControlSpain: Ethics CommitteeItaly: Ethics CommitteeFrance: Institutional Ethical CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Romania: Ethics CommitteeLithuania: Bioethics CommitteeCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 TNFa 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 ß-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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Canada	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
France	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
Hungary	Location n°6	Budapest
Hungary	Location n°8	Budapest
Hungary	Location n°7	Debrecen
Hungary	Location n°10	Eger
Hungary	Location n°9	Kistarcsa
Italy	Location n°15	Messina
Italy	Location n°16	Milano
Italy	Location n°17	Pisa
Lithuania	Location n°27	Kaunas
Lithuania	Location n°29	Klaipeda
Lithuania	Location n°30	Panevezys
Lithuania	Location n°28	Vilnius
Romania	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	Iasi
Romania	Location n°26	Iasi
Romania	Location n°18	Timisoara
Slovakia	Location n°12	Banska Bystrica
Slovakia	Location n°11	Piestany
Spain	Location n°3	Malaga
Spain	Location n°5	Oviedo

Sponsors (4)

Lead Sponsor	Collaborator
TcLand Expression S.A.	Medpharmgene, Inc., Premier Research Group plc, Theradis pharma

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Non-response to infliximab and methotrexate combination therapy based on American College of Rheumatology (ACR) criteria	A statistical analysis will be performed in order to evaluate the predictive performances of the test validated in the study primary objective in relation to the non-response to infliximab and methotrexate combination therapy evaluated according to ACR criteria.	at the time of the first response evaluation (between the 12th and the 14th week)	No