30 results
To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in RA subjects who have completed Study M13-550 or Study M13-537 Phase 2 RCT with ABT-494.
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…
The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic…
Objectives:To collect data on effect size for, and determine the feasibility of, a full scale multicentre RCT(Randomized Controlled Trial) that1. compares the efficacy and safety of NOACs with VKA treatment according to Dutchstandards, in VKA-…
To assess the normalization (reversal) of coagulation assays upon administration of two dosages of Prothrombin Complex Concentratre (PCC, Cofact®) in healthy volunteers treated with either rivaroxaban or apixaban
To demonstrate that oral apixaban 2.5 mg BID is superior to subcutaneous (SC)enoxaparin 40 mg QD in reducing the event rate on the composite endpoint of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death through Day 12 of…
To evaluate the safety (bleeding) of 4 doses of apixaban as compared to placebo over a 26 week treatment period in selected subjects with recent (<=7 days) Acute Coronary Syndrome (ACS). To determine the optimal dose and regimen of apixaban…
Primary:-To assess the impact of educational programme on implementation phase adherence in patients taking apixaban for Stroke Prevention in Non-Valvular Atrial Fibrillation (SPAF) at 24 weeks.Secondary:-To identify predictive risk factors linked…
Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…
Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…
To demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than VKA therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications. The substudy involving…
The objectives of this study are to determine the efficacy and safety of multiple doses of ABT-494 versus placebo and to assess the pharmacokinetics (PK) of ABT-494 following oral administration in subjects with moderately to severely active Crohn…
This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of upadacitinib low dose once daily (QD) and high dose QD versus placebo in participants with moderately to…
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…
Primary Objective: to obtain reliable estimates of the rates of vascular death and non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated ICH who are treated with apixaban versus those who are treated with APDs…
- To assess the safety and tolerability and to determine the RP2D of T-DXd plus durvalumab in combination with cisplatin, carboplatin or pemetrexed
Primary objective:To describe the overall treatment effect of T DXd in HER2+ MBC patients with or without baseline brain metastasisSecondary objectives:- To describe the treatment effect on the development and progression of brain metastasis in…
Main objectives:1. To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms as measured by proportion of subjects who achieve an Assessment of SpondyloArthritis international Society (ASAS) 40 response at…
The primary objective of this study is to evaluate the proportion of patients achieving FXI inhibition * 80% at trough (Day 91) after monthly dosing at 3 dose levels of MAA868.
To evaluate that the oral FXIa inhibitor BAY 2433334 when compared to apixaban leads to a lower incidence of bleeding in participants with AF