Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911234
• Other study ID #: TNF-K-006
• Secondary ID: 2013-001999-38
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: March 2019
• Source: Neovacs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 TNFa antagonist; or rituximab prior to the study.

• Has been treated with any other biological DMARDs

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• TNF-Kinoid
IM administration

Other:
• Placebo
IM administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Neovacs

Countries where clinical trial is conducted

Belgium,  Georgia,  Hungary,  Lebanon,  Macedonia, The Former Yugoslav Republic of,  Moldova, Republic of,  Poland,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DAS28-CRP between Month 6 and baseline.		Month 6
Secondary	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
Secondary	Immunogenicity: Anti-TNFa antibodies, Anti-TNFa neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines		Several timepoints during 24 weeks study period
Secondary	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