Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

Inclusion Criteria:

• Has had a diagnosis of RA according to the revised ACR criteria (Aletaha et al. 2010) for at least 6 months.
• Has been treated with and tolerated MTX for at least 3 months prior to the first administration of study product, - Has at least four swollen joints/66 and/or four tender joints/68,
• Has CRP ≥ 10 mg/L at screening.
• Is positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptides (CCP) antibodies at screening.

Exclusion Criteria:

• Has inflammatory rheumatic disease other than RA
• Has been treated with non-biological DMARDs/systemic immunosuppressives
• Has been treated with leflunomide within 12 weeks prior to first administration of study product.
• Has received intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids
• Has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another TNFα antagonist; or rituximab prior to the study.
• Has been treated with any other biological DMARDs