Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

• TNF-Kinoid (Biological), also known as ISA 51: IM administration
• Placebo (Other), also known as ISA 51: IM administration

Primary outcomes

• Change in DAS28-CRP between Month 6 and baseline. [Month 6]

Secondary outcomes

• Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline [Several timepoints during 24 weeks study period]
• Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines [Several timepoints during 24 weeks study period]
• Safety assessments will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory evaluations, and the recording of adverse events (AEs) [Several timepoints during 24 weeks study period]

Sex: All, ages: 18 Years to 75 Years

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