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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01911234
Other study ID # TNF-K-006
Secondary ID 2013-001999-38
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2013
Est. completion date September 2014

Study information

Verified date March 2019
Source Neovacs
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
TNF-Kinoid
IM administration
Other:
Placebo
IM administration

Locations

Country Name City State
Belgium Cliniques Universitaires Saint Luc Brussels
Georgia "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
Hungary BKS Research Kft. Albert Schweitzer Kórhaz es Rendelointezet-3. emelet Hatvan
Hungary CRU Hungary Kft. Szikszo
Hungary Csolnoky Ferenc Kórház Veszprém
Lebanon Ain Wazein Hospital Aïn Ouzaïn
Lebanon University Medical Center Rizk Hospital Beirut
Lebanon Hammoud Hospital Univeristy Medical Center Sidon
Macedonia, The Former Yugoslav Republic of University Clinic of Rheumatology Skopje
Moldova, Republic of IMSP Institutul de Cardiologie Chisinau
Poland Osteomedic Sc Bialystok
Poland NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie Kraków
Poland Centrum Badan Klinicznych SC. Poznan
Russian Federation Municipal Clinical Hospital #4 Ivanovo
Russian Federation Regional Clinical Hospital for War Veterans Kemerovo
Russian Federation City Clinical Hospital n.a.S.R.Mirotvortcev Saratov
Russian Federation Clinical Hospital for Emergency Care n.a. N.V.Solovyev Yaroslavl
Serbia Institute of Rheumatology Belgrade
Serbia Institute for treatment and rehabilitation "Niska Banja"-Nis Niska Banja
Ukraine 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

Sponsors (1)

Lead Sponsor Collaborator
Neovacs

Countries where clinical trial is conducted

Belgium,  Georgia,  Hungary,  Lebanon,  Macedonia, The Former Yugoslav Republic of,  Moldova, Republic of,  Poland,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in DAS28-CRP between Month 6 and baseline. Month 6
Secondary Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline Several timepoints during 24 weeks study period
Secondary Immunogenicity: Anti-TNFa antibodies, Anti-TNFa neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines Several timepoints during 24 weeks study period
Secondary 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) Several timepoints during 24 weeks study period
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