Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

March 20, 2019 updated by: Neovacs

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
  • Georgia
      • Tbilisi, Georgia
        • Tbilisi Heart and Vascular Clinic Ltd
      • Tbilisi, Georgia
        • "Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
      • Tbilisi, Georgia
        • "Medi Club Georgia" LLC
      • Tbilisi, Georgia
        • Diagnostic services LTD
  • Hungary
      • Hatvan, Hungary
        • BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet
      • Szikszo, Hungary
        • CRU Hungary Kft.
      • Veszprém, Hungary
        • Csolnoky Ferenc Korhaz
  • Lebanon
      • Aïn Ouzaïn, Lebanon
        • Ain Wazein Hospital
      • Beirut, Lebanon
        • University Medical Center Rizk Hospital
      • Sidon, Lebanon
        • Hammoud Hospital Univeristy Medical Center
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • University Clinic of Rheumatology
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • IMSP Institutul de Cardiologie
  • Poland
      • Bialystok, Poland
        • Osteomedic Sc
      • Kraków, Poland
        • NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
      • Poznań, Poland
        • Centrum Badań Klinicznych SC.
  • Russian Federation
      • Ivanovo, Russian Federation
        • Municipal Clinical Hospital #4
      • Kemerovo, Russian Federation
        • Regional Clinical Hospital for War Veterans
      • Saratov, Russian Federation
        • City Clinical Hospital n.a.S.R.Mirotvortcev
      • Yaroslavl, Russian Federation
        • Clinical Hospital for Emergency Care n.a. N.V.Solovyev
  • Serbia
      • Belgrade, Serbia
        • Institute of Rheumatology
      • Niska Banja, Serbia
        • Institute for treatment and rehabilitation "Niska Banja"-Nis
  • Ukraine
      • Donetsk, Ukraine
        • Donetsk City Clinical Hospital #5
      • Donetsk, Ukraine
        • Gusak Institute of Urgent and Recovery Surgery of AMSU
      • Kharkiv, Ukraine
        • Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"
      • Kyiv, Ukraine
        • Kyiv Out-patient hospital #2 of Shevchenko District
      • Kyiv, Ukraine
        • National medical academy of postgraduate education, Kiev regional clinical hospital
      • Simferopol, Ukraine
        • The Seventh Simferopol City Clinical Hospital
      • Zaporizhzhya, 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"
      • Zhytomyr, Ukraine
        • Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TNF-Kinoid
TNF Kinoid + ISA51
Biological: TNF-Kinoid
IM administration
Other Names:
  • ISA 51
PLACEBO_COMPARATOR: Placebo
Placebo + ISA51
Other: Placebo
IM administration
Other Names:
  • ISA 51

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in DAS28-CRP between Month 6 and baseline.
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Several timepoints during 24 weeks study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovacs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (ESTIMATE)

July 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNF-K-006
  • 2013-001999-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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