8 results
Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change at 26 weeks.
Primary objective:- To demonstrate that CT-P13 is noninferior to Remicade at Week 6 (Dose 3), in terms of efficacy, asdetermined by the Crohn*s Disease Activity Index (CDAI)-70 response rate.Secondary objectives:-To evaluate long-term secondary…
Primary: efficacy and safety of the addition of UMEC 62.5mcg once daily to ICS/LABA therapy, compared with placebo over 12 weeks in subjects with COPD.Secondary: effect of the addition of UMEC to ICS/LABA therapy on COPD-related health status…
The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…
Primary: To prove that infliximab in combination with azathioprine is superior to azathioprine alone in rapidly inducing a meaningful renal improvement, defined as a reduction in preoteinuria of at least 50%, in patients with membranous SLE…
The primary objective of the study is to demonstrate that patients with very early arthritis have a higher probability of achieving a state of clinical remission at end of infliximab therapy if treated with infliximab plus MTX when compared to MTX…
Primary:To compare the effect of UMEC/VI (62.5/25 mcg once daily) with UMEC (62.5 mcg once daily) on lung functionSecondary:To compare UMEC/VI, UMEC with salmeterol (50 mcg twice daily) on patient reported outcomes and on other COPD efficacy…
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…