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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01911234
Date of registration: 23/07/2013
Prospective Registration: Yes
Primary sponsor: Neovacs
Public title: Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis
Scientific title: 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
Date of first enrolment: September 2013
Target sample size: 143
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01911234
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Belgium Czech Republic Georgia Hungary Lebanon Macedonia, The Former Yugoslav Republic of Moldova, Republic of Poland
Russian Federation Serbia Ukraine
Contacts
Key inclusion & exclusion criteria

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 TNFa
antagonist; or rituximab prior to the study.

- Has been treated with any other biological DMARDs



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: TNF-Kinoid
Other: Placebo
Primary Outcome(s)
Change in DAS28-CRP between Month 6 and baseline. [Time Frame: Month 6]
Secondary Outcome(s)
Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline [Time Frame: Several timepoints during 24 weeks study period]
Immunogenicity: Anti-TNFa antibodies, Anti-TNFa neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines [Time Frame: 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) [Time Frame: Several timepoints during 24 weeks study period]
Secondary ID(s)
2013-001999-38
TNF-K-006
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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