Immunogenicity and Safety of TNFa Kinoid in Rheumatoid Arthritis With Secondary Resistance to TNFa Antagonists

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

October 31, 2012

Study Completion Date

September 30, 2013

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

TNFa Kinoid

TNFa kinoid

BIOLOGICAL

TNF kinoid

IM administration 2 or 3 injections within 28 days

Trial Locations (35)

1200

Cliniques Universitaires Saint Luc, Brussels

3000

Universiteit ZiekenHuis Katholiek Universiteit Leuven, Leuven

34295

Hôpital Lapeyronie, Montpellier

59037

C.H.U. Hôpital Roger Salengro, Lille

67098

CHU Strasbourg-Hautepierre, Strasbourg

75018

Hôpital Xavier Bichat, Paris

92100

Hôpital Ambroise Paré, Boulogne-Billancourt

93000

CHU Avicenne, Bobigny

94275

Hôpital Bicêtre, Université Paris-Sud 11, INSERM U802, Le Kremlin-Bicêtre

Unknown

Centro especializado en Investigaciones Medicas (CEIM), Buenos Aires

Hospital Sirio Libanes, Buenos Aires

Hospital Italiano de Cordoba, Córdoba

Centro de Investigaciones Reumatologicas, San Miguel de Tucumán

Centro Médico Privado de Reumatología, San Miguel de Tucumán

Universitaires Cliniques St. Luc (Mont-Godinne), Mont-Godinne

Diagnostic and Consulting Center SV, Plovdiv

Military Medical Academy, Sofia

"National Multiprofile Transport Hospital Tzar Boris III", Sofia

"University Hospital for Active Treatment Sveti Ivan Rilski", Sofia

MBAL University Stara Zagora, Stara Zagora

"Medical Center Chaika Ltd", Varna

"Sociedad Médica del Aparato Locomotor SA", Santiago

"Centro de Estudios Reumatológicos- Estudios Clínicos Limitada", Santiago

General Hospital Karlovac, Karlovac

Thalassotherapia, Opatija

KBC Split, Split

"Clinical Hospital Sveti Duh", Zagreb

University Hospital Sisters of Mercy, Zagreb

Hopital Pellegrin, Bordeaux

Hopital La Pitie Salpetriere, Paris

Hopital Lariboisière, Paris

"Dr. Constantin Opris Emergency County Hospital Baia Mare", Baia Mare

"Dr. I Cantacuzino Clinical Hospital", Bucharest

Ianuli Med Consult SRL, Bucharest

Rehabilitation Clinical Hospital Iasi, Iași

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Neovacs

INDUSTRY

NCT01040715 - Immunogenicity and Safety of TNFa Kinoid in Rheumatoid Arthritis With Secondary Resistance to TNFa Antagonists | Biotech Hunter | Biotech Hunter