56 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…
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…
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.
The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…
Evaluate long-term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa.
The objective of this study is to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week (eow) SC in maintaining remission in subjects with nr-axSpA.
Our main aim is to evaluate the effectiveness and cost-effectiveness of two tapering strategies:(i)DMARD tapering and (ii)anti-TNF tapering in RA patients with DMARD&anti-TNF(etanercept, adalimumab, certolizumab or golimumab) induced…
Primary ObjectiveTo demonstrate pharmacokinetic comparability of ONS-3010 (Oncobiologics), US-licensed Humira®, and EU-licensed Humira® following a single 40-mg subcutaneous (SC) dose in healthy adult subjects.Secondary ObjectiveTo evaluate the…
To assess the safety of lengthening the adalimumab dosing interval from 2 to 3 weeks, in patients with Crohn*s disease or ulcerative colitis in long term (6 months) remission.
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 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 objectives of this study are:* To determine the percentage of patients with recent-onset RA and UA who achieve and maintain clinical remission on treatment with a combination of methotrexate 25 mg/week and extended prednisone pulse (tapered high…
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.
We hypothesized that one of the key mechanisms explaining the differences in effect between adalumimab and etanercept on psoriatic skin is that adalumimab, by being a monoclonal antibody like infliximab, is a better inducer of apoptosis resulting in…
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…
The objective of this study is to assess the efficacy and safety of adalimumab in combination with a topical treatment for the treatment of patients with moderate to severe chronic plaque psoriasis.
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…