A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy - TNF-K-003

eovacs SA0 sites48 target enrollmentAugust 18, 2010

Overview

No summary available.

Registry

who.int

Start Date

August 18, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

eovacs SA

•1\.Diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR) (Arnett 1988\) since at least six months prior to first study product administration.
•2\.Patients who the Investigator believes are able and willing to comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow\-up visits).
•3\.A male or female between 18 and 70 years of age at the time of the first immunization.
•4\.Active RA disease as evidenced by a Disease Activity Score 28 (DAS 28\) \= 3\.2\.
•5\.History of treatment with TNFa antagonist (infliximab, adalimumab, etanercept, certolizumab, golimumab).
•6\.A wash\-out period before the first administration of the study product of:
•at least ten weeks since the last administration of certolizumab or golimumab
•at least eight weeks since the last administration of infliximab
•at least four weeks since the last administration of adalimumab or etanercept
•7\.History of positive response defined as an ACR20 or a DAS 28 decrease \= 1\.2 or by the investigator opinion with previous TNFa antagonist treatment.

•Patients meeting any of the following criteria will be excluded from participation in the study:
•1\.Treatment with non\-biological DMARDs within four weeks prior to first study product administration. MTX is allowed provided it is administered at a stable dosage \= 20mg/week since at least 4 weeks.
•2\.Treatment with any rheumatoid arthritis biological therapy other than TNFa antagonists at any time prior to first study product administration.
•3\.Administration of high doses of intra\-articular corticosteroids for the treatment of an acute mono\-arthritis (e.g. knee) within 3 months prior to first study product administration. High dose of corticosteroids is defined as \>50 mg triamcinolone or equivalent)
•4\.History of documented severe bacterial infection within 28 days prior to first immunization.
•5\.History of primary resistance or intolerance to any TNFa antagonist.
•6\.History of or current congestive heart failure, controlled or not.
•7\.Corticosteroids (prednisone, or equivalent, \=10 mg per day) are allowed if they are administered at stable dosage since at least 4 weeks prior to the first immunization. Inhaled and topical steroids are allowed.
•8\.Known history of tuberculosis (TB).
•9\.Suspicion of TB at chest X\-rays at screening or within three months prior to first administration of study product.