12 results
A multicenter randomized placebo controlled treatment study of leflunomide in polymyalgia rheumatica
To investigate whether the use of leflunomide can prevent relapses during glucocorticoid tapering in patients with polymyalgia rheumatica.
In a clinical trial it will be investigated to what extent combination therapy with LEF and HCQ will 1) inhibit disease activity, in particular improvement of ESSDAI and dryness and 2) inhibit activity of (autoreactive) B-cells, T-cells and pDCs. In…
To determine the feasibility of measuring SpO2 and HR by applying a pulse oximetry probe to the umbilical cord at birth in term neonates undergoing PBCC.
Main objective Monotherapy Cohorts (R/R CLL):• Identify the RP2D and the MTD of epcoritamab• Evaluate the safety and tolerability of epcoritamabExpansion Monotherapy (R/R CLL [Arm 1] and RS [Arm 2A]):• Assess the preliminary efficacy of…
Dose Escalation PhasePrimary - Evaluate the safety and tolerability of epcoritamab in combination with other agents Secondary- Characterize the PK properties of epcoritamab- To evaluate pharmacodynamic markers linked to efficacy and mechanism of…
Compare the clinical efficacy of Epcoritamab to SOC (R-GemOx or BR)
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong progression-free survival (PFS) compared with 6 cycles of standard R-…
Primary objective:To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine + mycophenolate mofetil) based on proportion of responder patients according to preliminary STAR at week 24.…
To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized clinical trial at 24 weeks, followed by a single-arm crossover and an open extension (total duration of 48 weeks)…
Dose Escalation (GEN3009 for R/R B-cell NHL Including CLL/SLL):- Determine the MTD with and/or determine the RP2D of GEN3009- Evaluate safety and tolerability of GEN3009Expansion (GEN3009 for R/R, DLBCL, FL, and CLL Cohorts):-Evaluate (preliminary)…
This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.