WHO ICTRP trial
A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with…
EUCTR2012-003486-18-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-003486-18-DE |
|---|---|
| Public title | A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritis |
| Scientific title | A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS |
| Primary sponsor | F. Hoffmann-La Roche Ltd. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany;United States;Spain;Russian Federation;United Kingdom;Italy |
| Conditions | Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders… |
| Interventions | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name… |
| Registration date | May 6, 2013 |
| Target size | 48 |
| Secondary IDs | WA28117;NCT01904279 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: