Rheumatoid Arthritis Clinical Trial
Official title:
A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological Therapy
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR) (Arnett 1988) since at least six months prior to first study product administration. - Male or female between 18 and 70 years of age at the time of the first immunization - Active RA disease as evidenced by a Disease Activity Score 28 (DAS 28) = 3.2. - Current or past treatment with an anti-TNF antagonist (infliximab, adalimumab,etanercept, certolizumab, golimumab). - A wash-out period before the first administration of the study product of at least ten weeks since the last administration of certolizumab or golimumab; at least eigth weeks since the last administration of infliximab; at least four weeks since the last administration of adalimumab or etanercept - History of positive response defined as an ACR20 or DAS 28 decrease = 1.2 or by the investigator opinion with previous TNFa antagonist treatment. - Secondary treatment failure to maximum one previous TNFa antagonist treatment as defined by: - Investigator opinion. OR - DAS28 increase = 0.6 during the last six months. OR - Decrease in European League Against Rheumatoid (EULAR) score. - Written informed consent . Exclusion Criteria: - Treatment with non-biological DMARDs within four weeks prior to first study product administration. MTX is allowed provided it is administered at as table dosage < ou = 20 mg/week since at least 4 weeks. - Treatment with any rheumatoid arthritis biological therapy other than TNFa antagonists at any time prior to first study product administration. - Administration of high doses of intra-articular corticosteroids for the treatment of an acute mono-arthritis (eg knee) within 3 months prior to first study product administration. High dose of corticosteroids is defined as > 50 mg triamcinolone or equivalent. - History of documented severe bacterial infection within 28 days prior to first immunization - History of primary resistance or intolerance to any TNFa antagonist. - History of or current congestive heart failure, controlled or not. - Corticosteroids (prednisone or equivalent, < ou = 10 mg per day) are allowed if they are administered at stable dosage since at lesat 4 weeks prior to the first immunization. Inhaled and topical steroids are allowed. - Known history of tuberculosis (TB). - Suspicion of TB at chest X-rays at screening or within three months prior to first administration of study product. - Suspicion of latent or active tuberculosis as defined by : - Positive Mantoux/Purified Protein Derivative (PPD)test (> ou = 5mm induration measured 48 to 72 hours after intradermal injection of tuberculin) at screening or within 30 days prior to first administration of study product. - and/or positive interferon-? (IFN ?) TB diagnostic test (as measured by the ELISpot method) at screening or within three months prior to first administration of study product. - Positive for HIV, HCV or HBV including HBsAg and anti-HBc antibodies. - Use of any investigational or non-registered product (drug or vaccine). - Administration of any live vaccine within three months prior to study entry - Any confirmed or suspected immunosuppressive or immunodeficient condition. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Centro especializado en Investigaciones Medicas (CEIM) | Buenos Aires | |
Argentina | Hospital Sirio Libanes | Buenos Aires | |
Argentina | Hospital Italiano de Cordoba | Cordoba | |
Argentina | Centro de Investigaciones Reumatologicas | San Miguel de Tucumán | |
Argentina | Centro Médico Privado de Reumatología | San Miguel de Tucumán | |
Belgium | Cliniques Universitaires Saint Luc | Brussels | |
Belgium | Universiteit ZiekenHuis Katholiek Universiteit Leuven | Leuven | |
Belgium | Universitaires Cliniques St. Luc (Mont-Godinne) | Mont-Godinne | |
Bulgaria | 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 | |
Chile | "Sociedad Médica del Aparato Locomotor SA" | Santiago de Chile | |
Chile | Centro de Estudios Reumatológicos- Estudios Clínicos Limitada" | Santiago de Chile | |
Croatia | General Hospital Karlovac | Karlovac | |
Croatia | Thalassotherapia | Opatija | |
Croatia | KBC Split | Split | |
Croatia | Clinical Hospital "Sveti Duh" | Zagreb | |
Croatia | University Hospital Sisters of Mercy | Zagreb | |
France | CHU Avicenne | Bobigny | |
France | Hopital Pellegrin | Bordeaux | |
France | Hôpital Ambroise Paré | Boulogne Billancourt | |
France | Hôpital Bicêtre, Université Paris-Sud 11, INSERM U802 | Le Kremlin Bicêtre | |
France | C.H.U. Hôpital Roger Salengro | Lille | |
France | Hôpital Lapeyronie | Montpellier | |
France | Hopital La Pitie Salpetriere | Paris | |
France | Hopital Lariboisière | Paris | |
France | Hôpital Xavier Bichat | Paris | |
France | CHU Strasbourg-Hautepierre | Strasbourg | |
Romania | "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 | Iasi |
Lead Sponsor | Collaborator |
---|---|
Neovacs |
Argentina, Belgium, Bulgaria, Chile, Croatia, France, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with at least a 3-fold increase in antibody response to TNFa vs baseline at day 38 | Day 38 | No | |
Secondary | Proportion of patients with a decrease of at least 1.2 in DAS28 at month 3 vs baseline | 3 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |