119 results
2 Objectives2.1 Primary objective •To evaluate FAZA-PET/CT as a prognostic factor of the loco-regional control rate at 2 years in HNSCC patients receiving chemo-radiotherapy ± nimorazole.•Time to locoregional recurrence is counted from the day of…
PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active radiographic axial spondyloarthritis (rad-axSpA) at Week 16.SecondaryThe major…
Primary:* To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.Secondary:* To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.* To evaluate the effect of…
The aim of this study is to prospectively explore the predictive value of a cDDP-sensitivity profile determined in CTCs of metastatic BC patients previously treated with at least antracycline- and taxane-based chemotherapy.
To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence…
Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…
Primary objectiveThe primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe HS.Secondary objectiveThe secondary objective of this study is to assess the safety, tolerability, immunogenicity,…
The primary objective of this study is to evaluate the long-term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease (CD) who participated in and successfully completed Study M14-115.The…
Primary:• To demonstrate the therapeutic equivalence of ONS-3010 (adalimumab biosimilar) compared toHumira® (adalimumab) in patients with plaque psoriasis Secondary:• To assess the safety, tolerability, and immunogenicity of ONS-3010 compared to…
To determine if there is a difference in the pharmacokinetics of low-dose cisplatin with and without prehydration.
To assess the efficacy and safety of treatment with tocilizumab versus adalimumab, both in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis who have had an inadequate efficacy response to treatment with…
Primary objective:The main objective of this study is to assess the feasibility, tolerability and the maximum tolerated dose (MTD) of oral AT-101 in combination with concurrent cisplatin-based chemotherapy and radiotherapy (RT) in advanced HNSCC, as…
To study the influence of anti-TNF therapy on the semen quality of IBD patients
The objectives of this study are to determine the safety and efficacy of two doses of adalimumab versus MTX in paediatric subjects with chronic plaque psoriasis, to determine the time to loss of disease control and the ability to regain response…
The primary objective is to determine the effect on progression-free survival (PFS) of adding MORAb-009 to the combination of pemetrexed and cisplatin in the treatment of subjects with unresectable malignant pleural mesothelioma (MPM). (Protocol ch…
To evaluate the long term maintenance of response, safety and tolerability of repeatedadministration of adalimumab in subjects with Ulcerative Colitis who participated in and successfullycompleted Protocol M06-826 or Protocol M06-827.The secondary…
The primary objective of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo as maintenance therapy in subjects…
The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous…
The primary objective of this study is to determine the clinical safety and efficacy of adalimumab compared to placebo in subjects with moderate to severe HS after 12 weeks of treatment. A secondary objective is to evaluate safety and explore…