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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01911234 |
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Date of registration:
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23/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis
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Scientific title:
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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 |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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143 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01911234 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Czech Republic
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Georgia
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Hungary
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Lebanon
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Macedonia, The Former Yugoslav Republic of
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Moldova, Republic of
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Poland
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Russian Federation
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Serbia
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Ukraine
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Biological: TNF-Kinoid
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Other: Placebo
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Primary Outcome(s)
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Change in DAS28-CRP between Month 6 and baseline.
[Time Frame: Month 6]
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Secondary Outcome(s)
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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]
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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]
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Immunogenicity: Anti-TNFa antibodies, Anti-TNFa neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
[Time Frame: Several timepoints during 24 weeks study period]
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Secondary ID(s)
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TNF-K-006
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2013-001999-38
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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