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Abatacept

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181. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. Full Text available with Trip Pro

Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. Discontinuation of rheumatoid arthritis (RA) treatment for lack or loss of initial response, tolerability issues, or development of antibodies against the therapeutic agent remains a challenge in clinical practice. Here we present a 6-month interim analysis of a 2-year prospective observational trial (...) in Europe and Canada aiming to assess the real-world effectiveness, safety, and tolerability of intravenous abatacept for the treatment of moderate-to-severe RA.ACTION (AbataCepT In rOutiNe clinical practice) is a prospective, observational study assessing effectiveness, safety, and tolerability of abatacept in patients with RA enrolled in Europe and Canada between May 2008 and January 2011. The patient population was divided into two groups: biologic naïve ('first-line') patients and patients who had

2014 BMC Musculoskeletal Disorders

182. An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's). Full Text available with Trip Pro

An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's). To determine the safety and efficacy of abatacept in non-severe relapsing granulomatosis with polyangiitis (Wegener's)(GPA).An open-label trial of intravenous abatacept was conducted in 20 patients with non-severe relapsing GPA. Prednisone up to 30 mg daily was permitted within the first 2 months, and patients on methotrexate, azathioprine, or mycophenolate mofetil continued (...) for all patients being 12.3 months (range 2-35 months). Eleven of the 15 (73%) patients on prednisone reached 0 mg. Nine severe adverse events occurred in 7 patients, including 7 infections that were successfully treated.In this study of patients with non-severe relapsing GPA, abatacept was well tolerated and was associated with a high frequency of disease remission and prednisone discontinuation.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under

2014 Annals of the Rheumatic Diseases

183. Proteinuria: abate or applaud abatacept in proteinuric kidney disease? (Abstract)

Proteinuria: abate or applaud abatacept in proteinuric kidney disease? T-lymphocyte activation antigen CD80 is a B-cell costimulator and podocyte injury marker originally described in lupus nephritis; CD80 blockade with abatacept disappointed in a lupus nephritis trial. A study now suggests abatacept efficacy in focal and segmental glomerulosclerosis. Small patient numbers and concurrent treatment regimens call for more definitive studies regarding this therapeutic strategy.

2014 Nature reviews. Nephrology

184. Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis - 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. Study of Abatacept (Orencia (...) Party): Christopher Bowlus, MD, University of California, Davis Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall). Condition or disease Intervention/treatment Phase Primary Biliary Cirrhosis Biological: abatacept Phase 4 Detailed Description: This is an open label

2014 Clinical Trials

185. A case of abatacept associated neutrophilic dermatosis and a review of the literature. (Abstract)

A case of abatacept associated neutrophilic dermatosis and a review of the literature. Abatacept is a novel biological agent that dampens the immune response by blocking the co-stimulation of T-cells, thus downregulating T-cell activation. It is currently approved for the treatment of rheumatoid arthritis (RA). The group of novel immunomodulatory agents, referred to as biologics, have now been used extensively, with established safety and side-effect profiles. There are, however, increasing (...) reports of adverse paradoxical reactions, most notably resulting from anti-tumour necrosis factor (TNF) therapy. While cutaneous adverse reactions to abatacept are rare, there are a few reports of such paradoxical reactions. We report a case of an idiosyncratic paradoxical neutrophilic dermatosis associated with the use of abatacept. © 2014 The Australasian College of Dermatologists.

2014 Australasian Journal of Dermatology

186. Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome

Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome - 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 (...) . Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome (ASAPIII) 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: NCT02067910 Recruitment Status : Active, not recruiting First Posted : February 20, 2014 Last Update Posted : March 19, 2019 Sponsor: University Medical Center Groningen

2014 Clinical Trials

187. Long Term Experience With Abatacept in Routine Clinical Practice

Long Term Experience With Abatacept in Routine Clinical Practice Long Term Experience With Abatacept in Routine Clinical Practice - 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. Long Term Experience (...) With Abatacept in Routine Clinical Practice (ACTION) 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: NCT02109666 Recruitment Status : Completed First Posted : April 10, 2014 Last Update Posted : April 19, 2017 Sponsor: Bristol-Myers Squibb Information provided by (Responsible Party): Bristol-Myers Squibb Study

2014 Clinical Trials

188. Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) - 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 the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) 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: NCT02108860 Recruitment Status

2014 Clinical Trials

189. Long-term Experience With Abatacept SC in Routine Clinical Practice

Long-term Experience With Abatacept SC in Routine Clinical Practice Long-term Experience With Abatacept SC in Routine Clinical Practice - 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. Long-term Experience (...) With Abatacept SC in Routine Clinical Practice (ASCORE) 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: NCT02090556 Recruitment Status : Active, not recruiting First Posted : March 18, 2014 Last Update Posted : November 14, 2018 Sponsor: Bristol-Myers Squibb Collaborators: inVentiv Health Clinical PharmaNet

2014 Clinical Trials

190. Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches

Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches - 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. Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (ABC) 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: NCT02270957 Recruitment Status : Recruiting First

2014 Clinical Trials

191. A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis - 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 (...) . A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis (ASSET) 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: NCT02161406 Recruitment Status : Completed First Posted : June 11, 2014 Last Update Posted : October 31, 2018 Sponsor: Dinesh Khanna, MD, MS Collaborators: Bristol-Myers

2014 Clinical Trials

192. Post-marketing Study Assessing the Long-Term Safety of Abatacept

Post-marketing Study Assessing the Long-Term Safety of Abatacept Post-marketing Study Assessing the Long-Term Safety of Abatacept - 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. Post-marketing Study (...) Assessing the Long-Term Safety of Abatacept 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: NCT02169544 Recruitment Status : Completed First Posted : June 23, 2014 Last Update Posted : April 25, 2017 Sponsor: Bristol-Myers Squibb Information provided by (Responsible Party): Bristol-Myers Squibb Study

2014 Clinical Trials

193. Open-label Pilot Study of Abatacept for the Treatment of Vitiligo

Open-label Pilot Study of Abatacept for the Treatment of Vitiligo Open-label Pilot Study of Abatacept for the Treatment of Vitiligo - 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. Open-label Pilot Study (...) of Abatacept for the Treatment of Vitiligo 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: NCT02281058 Recruitment Status : Active, not recruiting First Posted : November 3, 2014 Last Update Posted : August 9, 2017 Sponsor: Brigham and Women's Hospital Collaborator: Bristol-Myers Squibb Information provided

2014 Clinical Trials

194. Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial. Full Text available with Trip Pro

Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial. Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).The phase III, multinational Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE (ACQUIRE) trial comprised a 6-month, randomized, double-blind (DB) period, in which patients received

2014 The Journal of rheumatology Controlled trial quality: predicted high

195. Efficacy, safety, pharmacokinetics and immunogenicity of abatacept administered subcutaneously or intravenously in Japanese patients with rheumatoid arthritis and inadequate response to methotrexate: a Phase II/III, randomized study. (Abstract)

Efficacy, safety, pharmacokinetics and immunogenicity of abatacept administered subcutaneously or intravenously in Japanese patients with rheumatoid arthritis and inadequate response to methotrexate: a Phase II/III, randomized study. To evaluate efficacy and safety of subcutaneous (SC) and intravenous (IV) abatacept and background methotrexate (MTX) in Japanese patients with rheumatoid arthritis (RA) and inadequate response to MTX (MTX-IR).Double-dummy, double-blind study (NCT01001832); 118 (...) adults with ≥ 10 swollen joints, ≥ 12 tender joints and C-reactive protein (CRP) ≥ 0.8 mg/dL randomized 1:1 to SC abatacept (125 mg weekly) with IV loading (∼10 mg/kg on Day 1), or IV abatacept (∼10 mg/kg monthly) for 169 days, both also receiving MTX (6-8 mg/week). Primary endpoint was Day 169 American College of Rheumatology (ACR)20 response; other efficacy endpoints, safety and immunogenicity were assessed.Similar proportions of patients achieved ACR20 responses at Day 169 with SC (91.5% [95% CI

2014 Modern rheumatology / the Japan Rheumatism Association Controlled trial quality: predicted high

196. Co-Stimulation Modulation with Abatacept in Patients with Recent-Onset Type 1 Diabetes: Follow-Up One Year After Cessation of Treatment. Full Text available with Trip Pro

Co-Stimulation Modulation with Abatacept in Patients with Recent-Onset Type 1 Diabetes: Follow-Up One Year After Cessation of Treatment. OBJECTIVE We previously reported that 2 years of costimulation modulation with abatacept slowed decline of β-cell function in recent-onset type 1 diabetes (T1D). Subsequently, abatacept was discontinued and subjects were followed to determine whether there was persistence of effect. RESEARCH DESIGN AND METHODS Of 112 subjects (ages 6-36 years) with T1D, 77 (...) received abatacept and 35 received placebo infusions intravenously for 27 infusions over 2 years. The primary outcome-baseline-adjusted geometric mean 2-h area under the curve (AUC) serum C-peptide during a mixed-meal tolerance test (MMTT) at 2 years-showed higher C-peptide with abatacept versus placebo. Subjects were followed an additional year, off treatment, with MMTTs performed at 30 and 36 months. RESULTS C-peptide AUC means, adjusted for age and baseline C-peptide, at 36 months were 0.217 nmol/L

2014 Diabetes Care Controlled trial quality: uncertain

197. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. (Abstract)

Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. To assess the safety and efficacy of intravenous (IV) abatacept plus methotrexate (MTX) over 7 years, the longest observational period to date, in patients with established rheumatoid arthritis (RA) and an inadequate response to MTX.Patients randomised to IV abatacept (10 or 2 mg/kg) or placebo, plus MTX, during the 1-year double-blind (DB) period (...) of a Phase 2b study could enter the long-term extension (LTE) and receive IV abatacept 10 mg/kg monthly. Safety was assessed in patients who received ≥1 dose of abatacept; efficacy was assessed in patients originally randomised to 10 mg/kg abatacept (as-observed data).A total of 219 patients entered the LTE; 114 (52.1%) completed 7 years of treatment with abatacept plus MTX. Cumulative (DB + LTE) incidence rates of serious adverse events, serious infections, malignancies, and autoimmune events were 17.6

2014 Clinical and experimental rheumatology Controlled trial quality: uncertain

198. Reduction in CD4 Central Memory T-cell subset in Co-Stimulation Modulator Abatacept-Treated Patients with Recent-Onset Type 1 Diabetes is Associated with Slower C-Peptide Decline. Full Text available with Trip Pro

Reduction in CD4 Central Memory T-cell subset in Co-Stimulation Modulator Abatacept-Treated Patients with Recent-Onset Type 1 Diabetes is Associated with Slower C-Peptide Decline. We previously reported that continuous 24-month costimulation blockade by abatacept significantly slows the decline of β-cell function after diagnosis of type 1 diabetes. In a mechanistic extension of that study, we evaluated peripheral blood immune cell subsets (CD4, CD8-naive, memory and activated subsets, myeloid (...) associated with C-peptide decline at the subsequent visit. These changes were significantly affected by abatacept treatment, which drove the peripheral contraction of CM CD4 T cells and the expansion of naive (CD45R0(-)CD62L(+)) CD4 T cells in association with a significantly slower rate of C-peptide decline. The findings show that the quantification of CM CD4 T cells can provide a surrogate immune marker for C-peptide decline after the diagnosis of type 1 diabetes and that costimulation blockade may

2014 Diabetes Controlled trial quality: uncertain

199. Rheumatoid Arthritis Clinical Benefits from Abatacept, Cytokine Blockers, and Rituximab Are All Linked to Modulation of Memory B Cell Responses Full Text available with Trip Pro

Rheumatoid Arthritis Clinical Benefits from Abatacept, Cytokine Blockers, and Rituximab Are All Linked to Modulation of Memory B Cell Responses 24692519 2015 02 04 2018 12 02 0315-162X 41 5 2014 May The Journal of rheumatology J. Rheumatol. Rheumatoid arthritis clinical benefits from abatacept, cytokine blockers, and rituximab are all linked to modulation of memory B cell responses. 825-8 10.3899/jrheum.140022 Silverman Gregg J GJ Departments of Medicine and Pathology; Pelzek Adam A eng R01

2014 The Journal of rheumatology

200. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Full Text available with Trip Pro

Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA).AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA (...) and an inadequate response to MTX were randomised to 125 mg abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX.Of 646 patients randomised, 79.2% abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar

2014 Annals of the rheumatic diseases Controlled trial quality: uncertain

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