18 results
Primary ObjectiveThe primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with methotrexate to methotrexate alone in achieving Remission, defined as SDAI less than or equal to 3, at Week 24.…
Main objective:To assess the relapse rate (defined by clinical and biochemical parameters) over 24 months in patients with acute AAV presenting at first diagnosis of relapse, after 12 months of treatment with abatacept in combination with steroids…
Primary ObjectivesPlacebo-Controlled Induction Period: Primary Objective: Compare the proportion of subjects who have a clinical response (as defined by a reduction in Crohn*s Disease Activity Index [CDAI] >= 100 or an absolute CDAI score…
The primary objective for this study is to demonstrate that SC injections of abatacept are non-inferior to IV infusions of abatacept .
Placebo-Controlled Induction Period Primary Objective: Compare the proportion of subjects who have a clinical response at Week 12 between the abatacept and placebo treatment regimens.Maintenance Period Primary Objective: Compare the proportion of…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
Primary: to assess efficacy of weekly subcutaneous (SC) administration of Abatacept vs. placebo on disease activity assessed with ESSDAI at in patients with pSS. Secondary: to assess efficacy of Abatacept on clinical, functional, subjective, and…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
The purpose of the study is to evaluate how effective rilzabrutinib is and how safe it is, in reducing the signs and symptoms in patients with chronic spontaneous urticaria (CSU), who continue to have symptoms despite the use of H1-antihistamines (…
The primary objective of this study is:* To evaluate the effect of filgotinib compared to placebo in active psoriatic arthritis (PsA) as assessed by the American College of Rheumatology 20% improvement (ACR20) response at Week 12Secondary objectives…
The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Ulcerative Colitis (UC). Subjects who are biologic-naïve and…
The purpose of this study is to see how filgotinib, the experimental drug, affects male sperm and to see if it is a safe and effective treatment for men with moderately to severely active inlammatory bowel disease.
The aim of this clinical trial is to evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.
The primary objective is to evaluate whether a switching strategy using adalimumab concentration (TDM) is superior to usual care in rheumatoid arthritis patients failing adalimumab treatment with regard to response rates. The secondary objectives…
Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…
Main objective:1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-…
The sponsor is developing a biological product (DRL_AB) similar to the approved medicine Orencia®. As part of medical-scientific studies to confirm the similarity of the biological products, the Sponsor wants to compare DRL_AB with EU-approved…
The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of clinical remission, as well as , endoscopic response in subjects with moderately to severely active Crohn's disease (…