10 results
The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma…
1. To compare the efficacy of tofacitinib, in doses of 2 mg, 5 mg, and 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.2. To estimate the placebo-…
Primary Objective* To demonstrate the efficacy of tofacitinib in inducing remission in subjects with moderately to severely active UC.Secondary Objectives* To evaluate the safety and tolerability of tofacitinib in subjects with moderately to…
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
This is an exploratory study to assess changes in colonic inflammation after 8 weeks of treatment with tofacitinib (XELJANZ) 2 x 5 mg BID in patients with moderate to severely active UC.
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
Core:Core Primary Objective:* To investigate the safety and tolerability of OMO-1 when given orally to patients with locally advanced, unresectable or metastatic solid malignancies, alone or in combination with anti-cancer treatments, and define the…
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.