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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

143

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline

Completed

Started Sep 2013

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach

10 countries

31 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

July 23, 2013

Completed

7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed

1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

July 23, 2013

Last Update Submit

March 20, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Change in DAS28-CRP between Month 6 and baseline.
Month 6

Secondary Outcomes (3)

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
Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
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)
Several timepoints during 24 weeks study period

Study Arms (2)

TNF-Kinoid

EXPERIMENTAL

TNF Kinoid + ISA51

Biological: TNF-Kinoid

Placebo

PLACEBO COMPARATOR

Placebo + ISA51

Other: Placebo

Interventions

TNF-KinoidBIOLOGICAL

IM administration

Also known as: ISA 51

TNF-Kinoid

PlaceboOTHER

IM administration

Also known as: ISA 51

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Neovacslead

Study Sites (31)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

"Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC

Tbilisi, Georgia

Location

"Medi Club Georgia" LLC

Tbilisi, Georgia

Location

Diagnostic services LTD

Tbilisi, Georgia

Location

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, Georgia

Location

BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet

Hatvan, Hungary

Location

CRU Hungary Kft.

Szikszó, Hungary

Location

Csolnoky Ferenc Kórház

Veszprém, Hungary

Location

Ain Wazein Hospital

Aïn Ouzaïn, Lebanon

Location

University Medical Center Rizk Hospital

Beirut, Lebanon

Location

Hammoud Hospital Univeristy Medical Center

Sidon, Lebanon

Location

IMSP Institutul de Cardiologie

Chisinau, Moldova

Location

University Clinic of Rheumatology

Skopje, North Macedonia

Location

Osteomedic Sc

Bialystok, Poland

Location

NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie

Krakow, Poland

Location

Centrum Badań Klinicznych SC.

Poznan, Poland

Location

Municipal Clinical Hospital #4

Ivanovo, Russia

Location

Regional Clinical Hospital for War Veterans

Kemerovo, Russia

Location

City Clinical Hospital n.a.S.R.Mirotvortcev

Saratov, Russia

Location

Clinical Hospital for Emergency Care n.a. N.V.Solovyev

Yaroslavl, Russia

Location

Institute of Rheumatology

Belgrade, Serbia

Location

Institute for treatment and rehabilitation "Niska Banja"-Nis

Niška Banja, Serbia

Location

Donetsk City Clinical Hospital #5

Donetsk, Ukraine

Location

Gusak Institute of Urgent and Recovery Surgery of AMSU

Donetsk, Ukraine

Location

Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"

Kharkiv, Ukraine

Location

Kyiv Out-patient hospital #2 of Shevchenko District

Kyiv, Ukraine

Location

National medical academy of postgraduate education, Kiev regional clinical hospital

Kyiv, Ukraine

Location

The Seventh Simferopol City Clinical Hospital

Simferopol, Ukraine

Location

Municipal Institution "Central Hospital of Ordzhonikidze District"

Zaporizhzhya, Ukraine

Location

State Institution "Departmental Clinical Hospital of Railway Station Zaporizhzhya-2" of the State Enterprise "Prydniprovska Zaliznytsya"

Zaporizhzhya, Ukraine

Location

Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo

Zhytomyr, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

montanide ISA 51

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 30, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations

HU(3)NO(1)RU(4)SE(2)BE(1)MO(1)PL(3)GE(4)LE(3)UA(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

TNF-Kinoid

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations