31 results
Primary objective: 1. To evaluate the effect of ustekinumab in patients with moderate to severe hidradenitis suppurativa (Hurley II-III), measured by disease specific score systmes: Sartorius/HS-LASI and PGA 2. To evaluate possible changes in scores…
The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…
The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.
Primary: To demonstrate the superiority of secukinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16, compared to ustekinumab.Secondary: To demonstrate the superiority of secukinumab in…
Primary: To provide metastatic colorectal cancer patients with access to aflibercept and todocument the overall safety in these patientsSecondary: To document the Health-Related Quality of Life of aflibercept in this patientpopulation
Primary Objective: The primary objective of this exploratory trial is to evaluate the comparative safety through Week 12 of two treatment transition strategies in patients with inadequate response to methotrexate: discontinuation of methotrexate…
Primary Objective• To evaluate the efficacy and safety of ustekinumab in pediatric subjects aged >=6 through <12 years with moderate to severe chronic plaque psoriasis.Major Secondary Objectives• To evaluate the pharmacokinetics (PK)…
The primary objectives of this study are to assess whether 80 mg ixekizumab every 2 weeks (Q2W) is:• noninferior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by proportion of patients…
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…
INDUCTION STUDY Primary Objectives:* To evaluate the efficacy of intravenous (IV) ustekinumab in inducing clinical remission in subjects with moderately to severely active UC.* To evaluate the safety of IV ustekinumab in subjects with moderately to…
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…
ObjectivePlease describe:• the specific goal to be reached by the study• the hypothesis to be answered by the studyThe overall aim of the study is to determine which downstream cellular and molecular pathways involved in PsA pathogenesis are…
A *treat to target* strategy has been advocated as an optimized management approach for various diseases, by which strictly defined treatment targets facilitate decision making in clinical practice. Key to the success of this treatment strategy is…
Primary:- To evaluate the efficacy of the combination of temozolomide with vincristine and irinotecan in children and adult patients with relapsed rhabdomyosarcoma as assessed by confirmed objective tumor response.Secondary:- To evaluate the safety…
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…
The primary objective of this study is to determine whether the addition of induction chemotherapy to the neoadjuvant treatment of patients with locally recurrent rectal cancer results in more R0 resections compared to treatment with neoadjuvant…
Investigate whether perioperative mFOLFIRINOX improves overall survival compared to adjuvant mFOLFIRINOX in resectable pancreatic cancer.
The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to upfront repeat local treatment in patients with at least one locally treatable recurrent CRLM in the absence of…
The purpose of this study is to demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second- or third-line (2L-3L) cervical cancer (Overall Survival-OS)
Primary:Evaluate PK and efficacy of ustekinumab and guselkumab in jPsA. Secondary:Evaluate safety of ustekinumab and guselkumab in jPsAEvaluate immunogenicity of ustekinumab and guselkumab in jPsA