WHO ICTRP trial
The trial is designed to determine the safety and efficacy of ABP 501 compared…
EUCTR2013-000525-31-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2013-000525-31-GB |
|---|---|
| Public title | The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis |
| Scientific title | A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis |
| Primary sponsor | Amgen Inc |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany |
| Conditions | Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C]… |
| Interventions | Product Name: ABP 501 Product Code: ABP 501 Pharmaceutical Form: Solution for injection in pre-filled syringe Current Sponsor code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Concentration unit: mg/ml… |
| Registration date | Feb 7, 2013 |
| Target size | 500 |
| Secondary IDs | 20120262 |
| 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: