WHO ICTRP trial

A study to evaluate the effectiveness and safety of Apremilast in subjects with…

EUCTR2013-001590-25-HU · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2013-001590-25-HU
Public title A study to evaluate the effectiveness and safety of Apremilast in subjects with active psoriatic arthritis
Scientific title A PHASE 3B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) MONOTHERAPY IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
Primary sponsor Celgene Corporation
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries United States;Estonia;Czech Republic;Hungary;Canada;Spain;Romania;Australia;South Africa;Russian Federation;New Zealand
Conditions Psoriatic Arthritis MedDRA version: 16.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Interventions Product Name: Apremilast Product Code: CC-10004 Pharmaceutical Form: Tablet INN or Proposed INN: Apremilast CAS Number: 608141-41-9 Current Sponsor code: CC-10004 Concentration unit: mg milligram(s) Concentration type: equal Concentration…
Registration date Jan 8, 2013
Target size 298
Secondary IDs CC-10004-PSA-006
Registry page clinicaltrialsregister.eu

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