11 results
(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…
Safety: To provide scientific evidence that use of the VAS is safe as measured by the incidence of early-onset serious adverse events (SAEs).Effectiveness: To provide scientific evidence that use of the VAS provides an effective treatment for…
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…
Patients with ALS are routinely prescribed riluzole, the only registered drug for the treatment of ALS. This study will evaluate the concentration-effect relationship of riluzole (100 mg) and retigabine (300 mg) on axonal excitability measures. In…
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 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…
Primary: Long-term safety and tolerability.Secondary: Long-term efficacy.
Primary: To evaluate the efficacy of retigabine as adjunctive therapy to each of the following specified monotherapy AED treatments: carbamazepine/ oxcarbazepine, lamotrigine, levetiracetam or valproic acid in subjects with partial-onset seizures (…
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…