A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-019293-32

Femme et Homme

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Extrait

The primary objective of the study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (sc) CEP 33457 every 4 weeks over 72 weeks in patients with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457. Safety will be assessed by evaluating the following: •occurrence of adverse events •clinical laboratory tests (serum chemistry, hematology, and urinalysis) •vital signs (blood pressures, pulse, temperature, and body weight) measurements •12 lead ECG •physical examination findings, including physical examination symptom directed findings •concomitant medication usage


Critère d'inclusion

  • Patients with Systemic Lupus Erythematosus (SLE)