WHO ICTRP trial
Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al…
EUCTR2009-011137-26-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2009-011137-26-ES |
|---|---|
| Public title | Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE |
| Scientific title | Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio… |
| Primary sponsor | Schering-Plough Research Institute, A Division of Schering 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 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands |
| Conditions | Artritis reumatoide MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis |
| Interventions | Product Name: Golimumab Product Code: SCH 900259 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Golimumab… |
| Registration date | Jun 8, 2009 |
| Target size | 3150 |
| Secondary IDs | P06129;2009-011137-26-DE |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: