18 results
This study will be performed to evaluate the safety of the ACE stapler for the treatment of obesity. The secondary objective is to evaluate effectiveness of the ACE stapler for the treatment of obesity.
Evaluation of efficacy (as assessed by the stimulated whole saliva flow rate at 24 weeks) and safety of abatacept treatment in 15 patients with pSS.
- The main hypothesis of this study is that JIA patients at risk of a flare due to subclinical inflammatory activity may be identified by analysis of the phagocyte activity marker S100A12 and hsCRP. The goal is a stratification of the therapeutic…
The primary objective for this study is to demonstrate that SC injections of abatacept are non-inferior to IV infusions of abatacept .
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…
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…
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 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.…
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 aim of this clinical trial is to evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.
To investigate the effect of CTLA4-Ig (abatacept) on phenotype, transcriptional profile, B cell receptor usage and functional parameters of circulating B cells expressing anti-citrullinated protein antibodies (ACPA) in patients with early,…
The objective of the study is to compare conventional therapy with biological therapy in patients with early rheumatoid arthritis.
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
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 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 objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration).Secondary objectives:- To determine the…
Primary:To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG).Secondary:• To evaluate the impact of efgartigimod PH20 SC on disease severity• To evaluate the effect of…
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-…