Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis
NCT ID: NCT01911234
Last Updated: 2019-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2013-09-30
2014-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TNF-Kinoid
TNF Kinoid + ISA51
TNF-Kinoid
IM administration
Placebo
Placebo + ISA51
Placebo
IM administration
Interventions
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TNF-Kinoid
IM administration
Placebo
IM administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Neovacs
INDUSTRY
Responsible Party
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Locations
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Cliniques Universitaires Saint Luc
Brussels, , Belgium
"Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
Tbilisi, , Georgia
"Medi Club Georgia" LLC
Tbilisi, , Georgia
Diagnostic services LTD
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic LTD
Tbilisi, , Georgia
BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet
Hatvan, , Hungary
CRU Hungary Kft.
Szikszó, , Hungary
Csolnoky Ferenc Kórház
Veszprém, , Hungary
Ain Wazein Hospital
Aïn Ouzaïn, , Lebanon
University Medical Center Rizk Hospital
Beirut, , Lebanon
Hammoud Hospital Univeristy Medical Center
Sidon, , Lebanon
IMSP Institutul de Cardiologie
Chisinau, , Moldova
University Clinic of Rheumatology
Skopje, , North Macedonia
Osteomedic Sc
Bialystok, , Poland
NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
Krakow, , Poland
Centrum Badań Klinicznych SC.
Poznan, , Poland
Municipal Clinical Hospital #4
Ivanovo, , Russia
Regional Clinical Hospital for War Veterans
Kemerovo, , Russia
City Clinical Hospital n.a.S.R.Mirotvortcev
Saratov, , Russia
Clinical Hospital for Emergency Care n.a. N.V.Solovyev
Yaroslavl, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Institute for treatment and rehabilitation "Niska Banja"-Nis
Niška Banja, , Serbia
Donetsk City Clinical Hospital #5
Donetsk, , Ukraine
Gusak Institute of Urgent and Recovery Surgery of AMSU
Donetsk, , Ukraine
Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"
Kharkiv, , Ukraine
Kyiv Out-patient hospital #2 of Shevchenko District
Kyiv, , Ukraine
National medical academy of postgraduate education, Kiev regional clinical hospital
Kyiv, , Ukraine
The Seventh Simferopol City Clinical Hospital
Simferopol, , Ukraine
Municipal Institution "Central Hospital of Ordzhonikidze District"
Zaporizhzhya, , Ukraine
State Institution "Departmental Clinical Hospital of Railway Station Zaporizhzhya-2" of the State Enterprise "Prydniprovska Zaliznytsya"
Zaporizhzhya, , Ukraine
Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo
Zhytomyr, , Ukraine
Countries
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Other Identifiers
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2013-001999-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TNF-K-006
Identifier Type: -
Identifier Source: org_study_id
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