15 results
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…
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…
The study has the following 3 main objectives pertaining to the treatment of DMARD-naïve subjects with adult-onset, early, active, RA, diagnosed within 1 year before Screening using the 2010 ACR/EULAR RA classification criteria:1.To show that…
As of 15 June 2018, only patients from the ECH study (Study TV48125 CNS 30056) will enroll in this study for active treatment. As of 15 June 2018, all CCH patients included in this study have been asked to discontinue treatment, and are encouraged…
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…
The primary objective of this study is to demonstrate the efficacy of fremanezumab in the prevention of ECH in adult patients. The primary efficacy endpoint of this study is the mean change from baseline (run-in period) in the weekly average number…
(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…
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…
The primary objective of this study is to demonstrate the efficacy of fremanezumab in the prevention of CCH in adult patients:- The primary efficacy endpoint of this study is the mean change from baseline (run-in period) in the monthly average…
The primary objectives of this study are to assess whether there is transfer of CZP into breastmilk of lactating mothers who are receiving an established dosing regimen of CZP by evaluatingthe concentration of CZP in mature breast milk, and to…
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…
The primary objective of this study is to assess whether there is transfer of CZP across theplacenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants.The secondary and exploratory objectives are to assess the…
Given the limited effectiveness of available EGFR TKIs in patients with NSCLC with EGFR exon 20 insertion mutations, this subset patient population is routinely treated with chemotherapy, similar to patients with no driver mutations (ie, WT EGFR).…
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.