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Abatacept

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161. Abatacept for SLE Arthritis (IM101-330)

Abatacept for SLE Arthritis (IM101-330) Abatacept for SLE Arthritis (IM101-330) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Abatacept for SLE Arthritis (IM101-330) The safety and scientific validity (...) Information provided by (Responsible Party): Dr. Bevra Hahn, University of California, Los Angeles Study Details Study Description Go to Brief Summary: This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE. The purpose of this clinical research study is to evaluate the safety and effectiveness of treatment with abatacept (Abatacept) 125mg injected subcutaneously (under

2015 Clinical Trials

162. Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Effects of Abatacept in Patients With Early Rheumatoid Arthritis Effects of Abatacept in Patients With Early Rheumatoid Arthritis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Effects of Abatacept (...) -Myers Squibb Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis. Condition or disease Intervention/treatment Phase Rheumatoid Arthritis Drug: Abatacept Drug: Methotrexate Other: Abatacept Placebo Other: Methotrexate Placebo Phase 3 Detailed Description: Subcutaneous (SC) Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual

2015 Clinical Trials

163. Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan

Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail (...) Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government

2015 Clinical Trials

164. Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD) Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD) - Full Text View (...) - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis

2015 Clinical Trials

165. Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding (...) more. Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients (VACINA) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT02547493 Recruitment Status : Recruiting First Posted : September 11, 2015

2015 Clinical Trials

166. Incidence and complications of interstitial lung disease in users of tocilizumab, rituximab, abatacept and anti-tumor necrosis factor α agents, a retrospective cohort study Full Text available with Trip Pro

Incidence and complications of interstitial lung disease in users of tocilizumab, rituximab, abatacept and anti-tumor necrosis factor α agents, a retrospective cohort study Interstitial lung disease (ILD) is a common extra-articular condition in rheumatoid arthritis (RA), but few studies have systematically investigated its incidence and risk factors in patients receiving anti-tumor necrosis factor-alpha (anti-TNFα) agents or alternate mechanisms of action (MOAs) (e.g., T-cell, B-cell (...) , and interleukin-6 inhibitors).RA patients at least 18 years old were selected from the MarketScan databases (2010-2012) if they had at least one prescription/administration of abatacept, rituximab, tocilizumab, or anti-TNF after having discontinued a different biologic agent and meeting enrollment criteria. Cox models estimated the risk of incident ILD and ILD-related hospitalization. Sensitivity analyses used an alternate ILD case definition.We identified 13,795 episodes of biologic exposure in 11,219

2015 Arthritis research & therapy

167. Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries

Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved (...) Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our

2015 Clinical Trials

168. Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia

Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02778906 Recruitment Status : Unknown Verified May 2016 by University of Erlangen-Nürnberg Medical School. Recruitment status

2015 Clinical Trials

169. Abatacept in Juvenile Dermatomyositis

Abatacept in Juvenile Dermatomyositis Abatacept in Juvenile Dermatomyositis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Abatacept in Juvenile Dermatomyositis (AID) The safety and scientific validity (...) , George Washington University Study Details Study Description Go to Brief Summary: The purpose of this study is to assess the safety and efficacy of subcutaneous abatacept in 10 patients seven years of age and older with refractory JDM. Condition or disease Intervention/treatment Phase Dermatomyositis Drug: Abatacept Phase 4 Detailed Description: JDM is a chronic systemic autoimmune disease with a predominance of muscle and skin inflammation of unknown etiology and varying prognosis. Children with JDM

2015 Clinical Trials

170. Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA)

Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02598466 Recruitment Status : Completed First Posted : November 6, 2015 Last Update Posted : February 8, 2016 Sponsor: Bristol

2015 Clinical Trials

171. Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Full Text available with Trip Pro

Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. The efficacy and safety of abatacept in patients with juvenile idiopathic arthritis (JIA) who experienced an inadequate response to disease-modifying antirheumatic drugs were previously established in a phase III study that included a 4-month open-label lead-in period, a 6-month double-blind withdrawal period, and a long-term extension (LTE (...) ) phase. The aim of this study was to present the safety, efficacy, and patient-reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, for up to 7 years of followup.Patients enrolled in the phase III trial could enter the open-label LTE phase if they had not achieved a response to treatment at month 4 or if they had received abatacept or placebo during the double-blind period.One hundred fifty-three (80.5%) of 190 patients entered the LTE phase, and 69 patients (36.3

2015 Arthritis & rheumatology (Hoboken, N.J.) Controlled trial quality: uncertain

172. Predictive risk factors of serious infections in patients with rheumatoid arthritis treated with abatacept in common practice: results from the Orencia and Rheumatoid Arthritis (ORA) registry. (Abstract)

Predictive risk factors of serious infections in patients with rheumatoid arthritis treated with abatacept in common practice: results from the Orencia and Rheumatoid Arthritis (ORA) registry. Little data are available regarding the rate and predicting factors of serious infections in patients with rheumatoid arthritis (RA) treated with abatacept (ABA) in daily practice. We therefore addressed this issue using real-life data from the Orencia and Rheumatoid Arthritis (ORA) registry.ORA

2015 Annals of the Rheumatic Diseases

173. Gene expression changes reflect clinical response in a placebo-controlled randomized trial of abatacept in patients with diffuse cutaneous systemic sclerosis. Full Text available with Trip Pro

Gene expression changes reflect clinical response in a placebo-controlled randomized trial of abatacept in patients with diffuse cutaneous systemic sclerosis. Systemic sclerosis is an autoimmune disease characterized by inflammation and fibrosis of the skin and internal organs. We sought to assess the clinical and molecular effects associated with response to intravenous abatacept in patients with diffuse cutaneous systemic.Adult diffuse cutaneous systemic sclerosis patients were randomized (...) in a 2:1 double-blinded fashion to receive abatacept or placebo over 24 weeks. Primary outcomes were safety and the change in modified Rodnan Skin Score (mRSS) at week 24 compared with baseline. Improvers were defined as patients with a decrease in mRSS of ≥30% post-treatment compared to baseline. Skin biopsies were obtained for differential gene expression and pathway enrichment analyses and intrinsic gene expression subset assignment.Ten subjects were randomized to abatacept (n = 7) or placebo (n

2015 Arthritis research & therapy Controlled trial quality: predicted high

174. Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial. Full Text available with Trip Pro

Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial. For patients with rheumatoid arthritis (RA) whose treatment with a tumour necrosis factor inhibitor (TNFi) is failing, several biological treatment options are available. Often, another TNFi or a biological with another mode of action is prescribed. The objective of this study was to compare the effectiveness and cost (...) -effectiveness of three biologic treatments with different modes of action in patients with RA whose TNFi therapy is failing.We conducted a pragmatic, 1-year randomised trial in a multicentre setting. Patients with active RA despite previous TNFi treatment were randomised to receive abatacept, rituximab or a different TNFi. The primary outcome (Disease Activity Score in 28 joints) and the secondary outcomes (Health Assessment Questionnaire Disability Index and 36-item Short Form Health Survey scores) were

2015 Arthritis research & therapy Controlled trial quality: uncertain

175. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study) Full Text available with Trip Pro

Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study) To assess the effect of a temporary interruption in subcutaneous (SC) abatacept on immunogenicity, safety and efficacy in patients with active rheumatoid arthritis despite methotrexate in a phase III trial.Following a 12-week open-label introduction (period I; intravenous abatacept loading dose (...) and weekly fixed-dose SC abatacept 125 mg), patients were randomised 2:1 to double-blind SC placebo or SC abatacept for 12 weeks (period II). At the end of period II, patients receiving SC abatacept continued treatment and patients on placebo were reintroduced to SC abatacept (12-week open-label period III). The co-primary end points were ELISA-detected immunogenicity rate and safety at the end of period II. Efficacy was also monitored.Of 167 patients entering period I, 72% qualified for period II

2012 EvidenceUpdates Controlled trial quality: uncertain

176. Abatacept - Arthritis, Juvenile Idiopathic & Juvenile Rheumatoid

Abatacept - Arthritis, Juvenile Idiopathic & Juvenile Rheumatoid CEDAC FINAL RECOMMENDATION and REASONS for RECOMMENDATION ABATACEPT (Orencia ™ – Bristol-Myers Squibb Canada) New Indication: Juvenile Idiopathic Arthritis Description: Abatacept is a protein that selectively modulates a key co-stimulatory pathway required for full activation of T lymphocytes. Abatacept is indicated for reducing signs and symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA (...) )/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs, such as methotrexate. Abatacept has not been studied in children under 6 years of age. Previous CEDAC Recommendation for Abatacept: • Rheumatoid arthritis in adults (see Notice of CEDAC Final Recommendation, June 27, 2007) Dosage Forms: Supplied as abatacept 250 mg sterile powder for reconstitution. Abatacept is administered as a 30

2009 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

177. Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDs and anti-TNF inadequate responders for the management of moderate to severe rheumatoid arthritis Full Text available with Trip Pro

Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDs and anti-TNF inadequate responders for the management of moderate to severe rheumatoid arthritis Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDs and anti-TNF inadequate responders for the management of moderate to severe rheumatoid arthritis Cost-effectiveness modeling of abatacept versus other biologic agents in DMARDs and anti-TNF inadequate responders for the management of moderate (...) to severe rheumatoid arthritis Russell A, Beresniak A, Bessette L, Haraoui B, Rahman P, Thorne C, Maclean R, Dupont D Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study assessed the cost-effectiveness of abatacept for patients

2009 NHS Economic Evaluation Database.

178. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Full Text available with Trip Pro

Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. To evaluate clinical remission with subcutaneous abatacept plus methotrexate (MTX) and abatacept monotherapy at 12 months in patients with early rheumatoid arthritis (RA), and maintenance of remission following the rapid withdrawal of all RA treatment.In the Assessing Very (...) Early Rheumatoid arthritis Treatment phase 3b trial, patients with early active RA were randomised to double-blind, weekly, subcutaneous abatacept 125 mg plus MTX, abatacept 125 mg monotherapy, or MTX for 12 months. Patients with low disease activity (Disease Activity Score (DAS)28 (C reactive protein (CRP)) <3.2) at month 12 entered a 12-month period of withdrawal of all RA therapy. The coprimary endpoints were the proportion of patients with DAS28 (CRP) <2.6 at month 12 and both months 12 and 18

2014 Annals of the rheumatic diseases Controlled trial quality: uncertain

179. Squamous-cell carcinoma of the tongue following therapy of rheumatoid arthritis with abatacept Full Text available with Trip Pro

Squamous-cell carcinoma of the tongue following therapy of rheumatoid arthritis with abatacept A patient affected by rheumatoid arthritis developed a squamous-cell carcinoma probably due to abatacept, according to Naranjo algorithm. The case describes this adverse reaction for the first time and highlights the need for additional studies to establish the long-term risk profile of abatacept.

2014 Clinical Case Reports

180. The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug. Full Text available with Trip Pro

The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug. Rheumatoid Arthritis (RA) is one of the most common autoimmune diseases, affecting approximately 1% of the UK adult population. Patients suffer considerable pain, stiffness and swelling and can sustain various degrees of joint destruction, deformity (...) -TNF-inhibitor (TNFi) or abatacept are as effective as rituximab in patients with RA who have failed an initial TNFi drug.SWITCH is a pragmatic, phase IV, multi-centre, parallel-group design, open-label, randomised, controlled trial (RCT) comparing alternative-mechanism-TNFi and abatacept with rituximab in patients with RA who have failed an initial TNFi drug. Participants are randomised in a 1:1:1 ratio to receive alternative mechanism TNFi, (monoclonal antibodies: infliximab, adalimumab

2014 BMC musculoskeletal disorders Controlled trial quality: uncertain

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