Clinical trial NCT01911234: Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Neovacs
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 TNFα antagonist; or rituximab prior to the study.
* Has been treated with any other biological DMARDs

Primary outcomes:
measure: Change in DAS28-CRP between Month 6 and baseline.
timeFrame: Month 6
Secondary outcomes:
measure: Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline
timeFrame: Several timepoints during 24 weeks study period
measure: Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
timeFrame: Several timepoints during 24 weeks study period
measure: 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)
timeFrame: Several timepoints during 24 weeks study period
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Tbilisi
country: Georgia
facility: "Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
city: Tbilisi
country: Georgia
facility: "Medi Club Georgia" LLC
city: Tbilisi
country: Georgia
facility: Diagnostic services LTD
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic LTD
city: Hatvan
country: Hungary
facility: BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet
city: Szikszo
country: Hungary
facility: CRU Hungary Kft.
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Kórház
city: Aïn Ouzaïn
country: Lebanon
facility: Ain Wazein Hospital
city: Beirut
country: Lebanon
facility: University Medical Center Rizk Hospital
city: Sidon
country: Lebanon
facility: Hammoud Hospital Univeristy Medical Center
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic of Rheumatology
city: Chisinau
country: Moldova, Republic of
facility: IMSP Institutul de Cardiologie
city: Bialystok
country: Poland
facility: Osteomedic Sc
city: Kraków
country: Poland
facility: NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
city: Poznań
country: Poland
facility: Centrum Badań Klinicznych SC.
city: Ivanovo
country: Russian Federation
facility: Municipal Clinical Hospital #4
city: Kemerovo
country: Russian Federation
facility: Regional Clinical Hospital for War Veterans
city: Saratov
country: Russian Federation
facility: City Clinical Hospital n.a.S.R.Mirotvortcev
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital for Emergency Care n.a. N.V.Solovyev
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Niska Banja
country: Serbia
facility: Institute for treatment and rehabilitation "Niska Banja"-Nis
city: Donetsk
country: Ukraine
facility: Donetsk City Clinical Hospital #5
city: Donetsk
country: Ukraine
facility: Gusak Institute of Urgent and Recovery Surgery of AMSU
city: Kharkiv
country: Ukraine
facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"
city: Kyiv
country: Ukraine
facility: Kyiv Out-patient hospital #2 of Shevchenko District
city: Kyiv
country: Ukraine
facility: National medical academy of postgraduate education, Kiev regional clinical hospital
city: Simferopol
country: Ukraine
facility: The Seventh Simferopol City Clinical Hospital
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Central Hospital of Ordzhonikidze District"
city: Zaporizhzhya
country: Ukraine
facility: State Institution "Departmental Clinical Hospital of Railway Station Zaporizhzhya-2" of the State Enterprise "Prydniprovska Zaliznytsya"
city: Zhytomyr
country: Ukraine
facility: Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo
Study officials:
References: