60 results
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 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…
The primary objective is to investigate and compare the pharmacokinetic (PK) of MSB11022 acetate versus MSB11022-citrate in healthy subjects.
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…
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.
Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…
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…
To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patientswith moderate to severe chronic plaque psoriasis.
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 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 in subjects with inactive non-…
To find out the dynamics of cell biological changes in lesional skin during treatment with adalimumab. Secondary objectives:- To find out whether adalimumab treatment results in (1) a reduction of T cell subsets, (2) normalization of proliferation…
To study the influence of anti-TNF therapy on the semen quality of IBD patients
The aim of the study is to assess the efficacy and safety of treatment with adalimumab in patients with peripheral spondyloarthritis (without AS of PsA). Furthermore, the effect of adalimumab will be investigated on systemic and local disease…
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…
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…
The objective is to assess the effect of adalimumab on selfconfidence and sexuality of patients with anogenital psoriasis.
Objectives1. Determine efficacy of adalimumab as the first biologic agent or after previous use of other anti-TNF blocking agent. Efficacy will be evaluated by means of the ASAS 20% response criteria.2. Determine the efficacy of adalimumab on…
To assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
Primary objective:to study changes in synovial inflammation and cytokine expression in serial biopsy samples following the administration of adalimumab in patients with active rheumatoid arthritis.Secondary objectives: (i) assess clinical response…
To demonstrate the efficacy of adalimumab on mucosal healing in subjects with moderate to severe ileocolonic Crohn's disease and to delineate the safety of adalimumab when administered to subjects with Crohn's disease.