search
Back to results

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TNF-Kinoid
Placebo
Sponsored by
Neovacs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint Luc
  • "Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
  • "Medi Club Georgia" LLC
  • Diagnostic services LTD
  • Tbilisi Heart and Vascular Clinic LTD
  • BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet
  • CRU Hungary Kft.
  • Csolnoky Ferenc Kórház
  • Ain Wazein Hospital
  • University Medical Center Rizk Hospital
  • Hammoud Hospital Univeristy Medical Center
  • University Clinic of Rheumatology
  • IMSP Institutul de Cardiologie
  • Osteomedic Sc
  • NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
  • Centrum Badań Klinicznych SC.
  • Municipal Clinical Hospital #4
  • Regional Clinical Hospital for War Veterans
  • City Clinical Hospital n.a.S.R.Mirotvortcev
  • Clinical Hospital for Emergency Care n.a. N.V.Solovyev
  • Institute of Rheumatology
  • Institute for treatment and rehabilitation "Niska Banja"-Nis
  • Donetsk City Clinical Hospital #5
  • Gusak Institute of Urgent and Recovery Surgery of AMSU
  • Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"
  • Kyiv Out-patient hospital #2 of Shevchenko District
  • National medical academy of postgraduate education, Kiev regional clinical hospital
  • The Seventh Simferopol City Clinical Hospital
  • Municipal Institution "Central Hospital of Ordzhonikidze District"
  • State Institution "Departmental Clinical Hospital of Railway Station Zaporizhzhya-2" of the State Enterprise "Prydniprovska Zaliznytsya"
  • Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNF-Kinoid

Placebo

Arm Description

TNF Kinoid + ISA51

Placebo + ISA51

Outcomes

Primary Outcome Measures

Change in DAS28-CRP between Month 6 and baseline.

Secondary Outcome Measures

Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline
Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
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)

Full Information

First Posted
July 23, 2013
Last Updated
March 20, 2019
Sponsor
Neovacs
search

1. Study Identification

Unique Protocol Identification Number
NCT01911234
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neovacs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNF-Kinoid
Arm Type
Experimental
Arm Description
TNF Kinoid + ISA51
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + ISA51
Intervention Type
Biological
Intervention Name(s)
TNF-Kinoid
Other Intervention Name(s)
ISA 51
Intervention Description
IM administration
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
ISA 51
Intervention Description
IM administration
Primary Outcome Measure Information:
Title
Change in DAS28-CRP between Month 6 and baseline.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
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
Title
Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
Time Frame
Several timepoints during 24 weeks study period
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
"Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
City
Tbilisi
Country
Georgia
Facility Name
"Medi Club Georgia" LLC
City
Tbilisi
Country
Georgia
Facility Name
Diagnostic services LTD
City
Tbilisi
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic LTD
City
Tbilisi
Country
Georgia
Facility Name
BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet
City
Hatvan
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Szikszo
Country
Hungary
Facility Name
Csolnoky Ferenc Kórház
City
Veszprém
Country
Hungary
Facility Name
Ain Wazein Hospital
City
Aïn Ouzaïn
Country
Lebanon
Facility Name
University Medical Center Rizk Hospital
City
Beirut
Country
Lebanon
Facility Name
Hammoud Hospital Univeristy Medical Center
City
Sidon
Country
Lebanon
Facility Name
University Clinic of Rheumatology
City
Skopje
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
IMSP Institutul de Cardiologie
City
Chisinau
Country
Moldova, Republic of
Facility Name
Osteomedic Sc
City
Bialystok
Country
Poland
Facility Name
NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
City
Kraków
Country
Poland
Facility Name
Centrum Badań Klinicznych SC.
City
Poznań
Country
Poland
Facility Name
Municipal Clinical Hospital #4
City
Ivanovo
Country
Russian Federation
Facility Name
Regional Clinical Hospital for War Veterans
City
Kemerovo
Country
Russian Federation
Facility Name
City Clinical Hospital n.a.S.R.Mirotvortcev
City
Saratov
Country
Russian Federation
Facility Name
Clinical Hospital for Emergency Care n.a. N.V.Solovyev
City
Yaroslavl
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
Country
Serbia
Facility Name
Institute for treatment and rehabilitation "Niska Banja"-Nis
City
Niska Banja
Country
Serbia
Facility Name
Donetsk City Clinical Hospital #5
City
Donetsk
Country
Ukraine
Facility Name
Gusak Institute of Urgent and Recovery Surgery of AMSU
City
Donetsk
Country
Ukraine
Facility Name
Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"
City
Kharkiv
Country
Ukraine
Facility Name
Kyiv Out-patient hospital #2 of Shevchenko District
City
Kyiv
Country
Ukraine
Facility Name
National medical academy of postgraduate education, Kiev regional clinical hospital
City
Kyiv
Country
Ukraine
Facility Name
The Seventh Simferopol City Clinical Hospital
City
Simferopol
Country
Ukraine
Facility Name
Municipal Institution "Central Hospital of Ordzhonikidze District"
City
Zaporizhzhya
Country
Ukraine
Facility Name
State Institution "Departmental Clinical Hospital of Railway Station Zaporizhzhya-2" of the State Enterprise "Prydniprovska Zaliznytsya"
City
Zaporizhzhya
Country
Ukraine
Facility Name
Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo
City
Zhytomyr
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs