13 results
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…
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…
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…
Evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy attacks.Evaluate the additive/synergistic effect of the combination of BF2.649 and Modafinil on excessive daytime sleepiness (EDS…
· Evaluate the efficacy and safety of BF2.649 administered by escalating doses and followed by 5-week stable doses in narcoleptic patients with excessive daytime sleepiness (EDS) as compared to placebo.· Evaluate the efficacy and safety of BF2.649…
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…
To evaluate the effect of chemotherapy on the serological and cellular immune response to influenza virus vaccination in patients with breast or colorectal cancer in order to establisch the optimal timing of vaccination during treatment with…
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…
(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…
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 objective of the study is to compare conventional therapy with biological therapy in patients with early rheumatoid arthritis.