A Phase 2 interventional study of TNF-Kinoid and Placebo in Rheumatoid Arthritis, sponsored by Neovacs. Completed at 31 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by Neovacs · Phase 2, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 143 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Neovacs is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TNF Kinoid + ISA51
Biological: TNF-Kinoid
Placebo + ISA51
Other: Placebo
IM administration
Also known as: ISA 51
IM administration
Also known as: ISA 51
Change in DAS28-CRP between Month 6 and baseline.
Time frame: Month 6
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-TNFα antibodies, Anti-TNFα 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
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Neovacs