Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Placebo; Biological: TNF-Kinoid

• Registration Number: NCT01911234
• Lead Sponsor: Neovacs

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Study Start: 2013-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo + ISA51
TNF-Kinoid	TNF-Kinoid	TNF Kinoid + ISA51

Primary Outcome Measures

Name	Time	Method
Change in DAS28-CRP between Month 6 and baseline.	Month 6

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (31)

Hammoud Hospital Univeristy Medical Center; 🇱🇧 Sidon, Lebanon

BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet; 🇭🇺 Hatvan, Hungary

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

"Medi Club Georgia" LLC; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic LTD; 🇬🇪 Tbilisi, Georgia

CRU Hungary Kft.; 🇭🇺 Szikszo, Hungary

University Medical Center Rizk Hospital; 🇱🇧 Beirut, Lebanon

IMSP Institutul de Cardiologie; 🇲🇩 Chisinau, Moldova, Republic of

Osteomedic Sc; 🇵🇱 Bialystok, Poland

"Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC; 🇬🇪 Tbilisi, Georgia

Csolnoky Ferenc Kórház; 🇭🇺 Veszprém, Hungary

Diagnostic services LTD; 🇬🇪 Tbilisi, Georgia

Ain Wazein Hospital; 🇱🇧 Aïn Ouzaïn, Lebanon

University Clinic of Rheumatology; 🇲🇰 Skopje, Macedonia, The Former Yugoslav Republic of

Donetsk City Clinical Hospital #5; 🇺🇦 Donetsk, Ukraine

The Seventh Simferopol City Clinical Hospital; 🇺🇦 Simferopol, Ukraine

Regional Clinical Hospital for War Veterans; 🇷🇺 Kemerovo, Russian Federation

Clinical Hospital for Emergency Care n.a. N.V.Solovyev; 🇷🇺 Yaroslavl, Russian Federation

Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"; 🇺🇦 Kharkiv, Ukraine

Kyiv Out-patient hospital #2 of Shevchenko District; 🇺🇦 Kyiv, Ukraine

NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie; 🇵🇱 Kraków, Poland

Centrum Badań Klinicznych SC.; 🇵🇱 Poznań, Poland

Municipal Clinical Hospital #4; 🇷🇺 Ivanovo, Russian Federation

City Clinical Hospital n.a.S.R.Mirotvortcev; 🇷🇺 Saratov, Russian Federation

Institute of Rheumatology; 🇷🇸 Belgrade, Serbia

Institute for treatment and rehabilitation "Niska Banja"-Nis; 🇷🇸 Niska Banja, Serbia

Gusak Institute of Urgent and Recovery Surgery of AMSU; 🇺🇦 Donetsk, Ukraine

State Institution "Departmental Clinical Hospital of Railway Station Zaporizhzhya-2" of the State Enterprise "Prydniprovska Zaliznytsya"; 🇺🇦 Zaporizhzhya, Ukraine

Municipal Institution "Central Hospital of Ordzhonikidze District"; 🇺🇦 Zaporizhzhya, Ukraine

Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo; 🇺🇦 Zhytomyr, Ukraine

National medical academy of postgraduate education, Kiev regional clinical hospital; 🇺🇦 Kyiv, Ukraine