Active Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: TNF-Kinoid
Product Code: TNF-K
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: not assigned yet
Current Sponsor code: TNF-K
Other descriptive name: TNF-Kinoid
Concentra
Sponsors
Neovacs SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who meets all of the following criteria will be eligible to participate in this study: 1.Be a male or female of between 18 and 75 years of age at the time of randomization. 2.Has had a diagnosis of RA according to the revised ACR criteria (Aletaha et al., 2010) for at least 6 months. 3.Has been treated with and tolerated MTX at a dose of at least 10 mg/week for at least 3 months prior to the first administration of study product, with a MTX dose of = 10 mg/week and =20 mg/week that has been stable for at least 4 weeks prior to first administration of study product. (Note: patients who weigh = 40 kg will be allowed a minimum MTX dose of 7.5 mg/week.) 4.Has at least four swollen joints/66 and/or four tender joints/68, at screening and baseline (SD1). 5.Has CRP=10mg/L at screening. Note: patients may be retested in 7–14 days only if their initial screening value is =65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria will not be enrolled in the study: 1.Has inflammatory rheumatic disease other than RA, including but not limited to, psoriatic arthritis, ankylosingspondyl arthritis, systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of study therapy. 2.Has been treated with non-biological DMARDs/systemic immunosuppressives(e.g., D-penicillamine, sulfasalazine, azathioprine, cyclosporine, mycophenolatemofetil) other than MTX or hydroxychloroquine within 4 weeks prior to the first administration of study product. 3.Has been treated with leflunomide within 12 weeks prior to first administration of study product. 4.Has received intra-articular, IM, or intravenous (IV) corticosteroids, including adrenocorticotropic hormone, within 4 weeks prior to first administration of study product. 5.Has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another TNFa antagonist; or rituximab prior to the study. 7.Has been treated with any other biological DMARDs (e.g., tocilizumab, abatacept, anakinra) or with a Janus-activated kinase (JAK) inhibitor within 6 months prior to first study product administration. 8.Has had a non-tuberculous mycobacterial infection or opportunistic infection (e.g., Pneumocystis carinii, aspergillosis) within 6 months prior to first administration of study product. 9.Has received any live virus or bacterial vaccination within 3 months prior to the first administration of study product. 10.Has a serious infection (e.g., hepatitis, pneumonia, pyelonephritis, or sepsis), has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months prior to the first administration of study product. Less serious infections (e.g., acute upper respiratory tract infection, simple urinary tract infection) may not be considered exclusionary at the discretion of the Investigator. 11.Has ongoing, chronic, or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis); recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic non remitting cystitis); or an open, draining, or infected skin wound or ulcer. 12.Has a history of or current congestive heart failure, even if well controlled. 13.Has known history of TB. 14.Has positive IFN? TB diagnostic test (Quantiferon Gold) at screening. 15.The Investigator suspects TB based on a chest X-ray conducted at screening or within 3 months prior to first administration of study product. 16.Is human immunodeficiency virus (HIV) antibody-positive, hepatitis C (HCV) antibody-positive, or hepatitis B surface antigen(HBsAg)-positive at screening. 17.Has used any investigational or non-registered drug within 30 days or five half-lives, whichever is longer; or any investigational or non-registered vaccine within 30 days preceding the first dose of study product. 18.Is pregnant or breastfeeding. 19.Has a history of malignant cancer, with the exception of the following cancers, if they have been adequately treated: cervical carcinoma in situ, basal cell carcinoma, localized bladder cancer, or dermatological squamous cell carcinoma. 20.Has a history of allergic disease or reactions likely to be exacerbated by any component of the study product. 21.Has a history of or active lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate superior clinical efficacy of TNF-K compared to placebo.;Secondary Objective: The secondary objectives of this study are: •To evaluate the clinical response by assessing disease activity scores and inflammatory markers •To evaluate immune response parameters (anti-TNFa and anti-KLH antibody titers and anti-TNFa neutralizing capacities) •To identify correlates between clinical efficacy and immune response parameters •To assess the safety and reactogenicity of TNF-K ;Primary end point(s): Change in DAS28-CRP between SD169 and baseline.;Timepoint(s) of evaluation of this end point: at study day (SD) 169 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •ACR20, ACR50, ACR70 response at SD85, SD113 and SD169 versus baseline. •Clinical response as defined by a = 1.2 decrease in DAS28-CRP score at SD71, SD85, SD113 and SD169 versus baseline. •Geometric mean titers (GMTs) of anti-TNFa antibodies at SD1, SD29, SD50, SD71, SD85, SD113, and SD169. •Positive anti-TNFa neutralizing activity at SD85, SD113 and SD169. ;Timepoint(s) of evaluation of this end point: at study days (SD): 1, 29, 50, 71, 85, 113, 169 | — |
Countries
Belgium, Czech Republic, Georgia, Hungary, Lebanon, Macedonia, the former Yugoslav Republic of, Moldova, Republic of, Poland, Russian Federation, Serbia, Ukraine
Contacts
Public ContactChief Medical Officer
Neovacs SA
Outcome results
None listed