22 results
PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W) versus placebo in patients with active rad-axSpA at Week 16.SecondaryThe major secondary objective is:To compare both ixekizumab regimens (80 mg Q2W or 80…
The primary objective is to compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W) versus placebo in patients with active nonrad-axSpA at Week 16The major secondary objectives is to compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W versus…
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…
The primary objective of the study is to assess whether ixekizumab 80 mg every 2 weeks (Q2W) or80 mg every 4 weeks (Q4W) is superior to placebo in the treatment of biologic disease-modifying antirheumatic drug (bDMARD)-naive patients with active…
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…
Certolizumab pegol is a humanized Fab* conjugated to PEG with specificity for human TNF*. Certolizumab pegol has demonstrated efficacy in clinical studies of Crohn*s disease (CD), PSO, and RA. The objective of this study is to demonstrate the…
Certolizumab pegol is a PEGylated humanized Fab* fragment with specificity for humanTNF*. Certolizumab pegol has demonstrated efficacy in clinical studies of Crohn*s disease(CD), psoriasis (PSO), and RA. The objective of this study is to demonstrate…
The aim of the study is twofold. The first is the impact of DRL-21994 and the registered product on the release of vessels studied and compared. The second is the speed with which DRL-21994 is included in the body examined, as well as the degree of…
The purpose of this study is to identify the first time-point the OMERACT RAMRIS score for the activity of synovitis is statistically significantly reduced compared to Baseline, in response to cerolizumab pegol (CZP) therapy. In addition, the early…
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…
Co-Primary- to assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects(children and adolescents) with moderate-to-severe plaque psoriasis as measured by PASI 75 and by sPGA (0,1)Gated…
The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…
Primary objective:The primary objective of the study will be to demonstrate the effect of CZP treatment on the reduction of AU flares in subjects with both active axSpA and a documented history of AU.Secondary objective:The secondary objectives of…
Primary objective:-To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by American Collegeof Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI 100)Major…
PrimaryTo assess systemic CZP exposure across the course of pregnancy in study participants with chronic inflammatory diseases.Secundary To assess the formation of anti-CZP antibodies across the course of pregnancy To assess the safety of CZP in…
The objective of the study is to compare conventional therapy with biological therapy in patients with early rheumatoid arthritis.
(Protocol v1.0 25Jul2014 p.18) The primary objective of the study is to compare the efficacy of certolizumab pegol (CZP) administered subcutaneously at the doses of CZP 400mg every two weeks and CZP 200mg every two weeks after a loading dose of CZP…
Objectives: The primary objectives of the study are to assess whether 80 mg LY2439821 every 2 weeks (Q2W) or every 4 weeks (Q4W) is:* Superior to placebo at Week 12 in the treatment of patients with moderate-to-severe plaque Ps as measured by: o…
Primary objective:-To evaluate in patients having achieved a state of sustained remission whether the ixekizumab treatment group is superior to the placebo group in maintaining response during the randomized-withdrawal periodSecondary objectives:-To…
The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose…