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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012041-35 | Registry Identifier | EMEA |
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The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously treated with anti-TNFα mAb but have lost susceptibility to therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNFa Kinoid dose 1 | Experimental |
| |
| TNFa Kinoid dose 2 | Experimental |
| |
| TNFa Kinoid dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNFa Kinoid | Biological | TNFa kinoid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least a 3-fold increase in antibody response to TNFa vs baseline at day 38 | Day 38 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a decrease of at least 1.2 in DAS28 at month 3 vs baseline | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Durez, MD | Cliniques Universitaires St Luc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro especializado en Investigaciones Medicas (CEIM) | Buenos Aires | Argentina | ||||
| Hospital Sirio Libanes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25517733 | Derived | Durez P, Vandepapeliere P, Miranda P, Toncheva A, Berman A, Kehler T, Mociran E, Fautrel B, Mariette X, Dhellin O, Fanget B, Ouary S, Grouard-Vogel G, Boissier MC. Therapeutic vaccination with TNF-Kinoid in TNF antagonist-resistant rheumatoid arthritis: a phase II randomized, controlled clinical trial. PLoS One. 2014 Dec 17;9(12):e113465. doi: 10.1371/journal.pone.0113465. eCollection 2014. |
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| TNF kinoid | Biological | IM administration 2 or 3 injections within 28 days |
|
| Buenos Aires |
| Argentina |
| Hospital Italiano de Cordoba | Córdoba | Argentina |
| Centro de Investigaciones Reumatologicas | San Miguel de Tucumán | Argentina |
| Centro Médico Privado de Reumatología | San Miguel de Tucumán | Argentina |
| Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Universiteit ZiekenHuis Katholiek Universiteit Leuven | Leuven | 3000 | Belgium |
| Universitaires Cliniques St. Luc (Mont-Godinne) | Mont-Godinne | Belgium |
| Diagnostic and Consulting Center SV | Plovdiv | Bulgaria |
| Military Medical Academy | Sofia | Bulgaria |
| National Multiprofile Transport Hospital "Tzar Boris III" | Sofia | Bulgaria |
| University Hospital for Active Treatment "Sveti Ivan Rilski" | Sofia | Bulgaria |
| MBAL University Stara Zagora | Stara Zagora | Bulgaria |
| Medical Center "Chaika" Ltd | Varna | Bulgaria |
| "Sociedad Médica del Aparato Locomotor SA" | Santiago | Chile |
| Centro de Estudios Reumatológicos- Estudios Clínicos Limitada" | Santiago | Chile |
| General Hospital Karlovac | Karlovac | Croatia |
| Thalassotherapia | Opatija | Croatia |
| KBC Split | Split | Croatia |
| Clinical Hospital "Sveti Duh" | Zagreb | Croatia |
| University Hospital Sisters of Mercy | Zagreb | Croatia |
| CHU Avicenne | Bobigny | 93000 | France |
| Hopital Pellegrin | Bordeaux | France |
| Hôpital Ambroise Paré | Boulogne-Billancourt | 92100 | France |
| Hôpital Bicêtre, Université Paris-Sud 11, INSERM U802 | Le Kremlin-Bicêtre | 94275 | France |
| C.H.U. Hôpital Roger Salengro | Lille | 59037 | France |
| Hôpital Lapeyronie | Montpellier | 34295 | France |
| Hôpital Xavier Bichat | Paris | 75018 | France |
| Hopital La Pitie Salpetriere | Paris | France |
| Hopital Lariboisière | Paris | France |
| CHU Strasbourg-Hautepierre | Strasbourg | 67098 | France |
| "Dr. Constantin Opris" Emergency County Hospital Baia Mare | Baia Mare | Romania |
| "Dr. I Cantacuzino" Clinical Hospital | Bucharest | Romania |
| Ianuli Med Consult SRL | Bucharest | Romania |
| Rehabilitation Clinical Hospital Iasi | Iași | Romania |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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