WHO ICTRP trial
Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis…
EUCTR2016-000933-37-HU · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2016-000933-37-HU |
|---|---|
| Public title | Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE) |
| Scientific title | A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic… |
| Primary sponsor | AbbVie Deutschland GmbH & Co. KG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Czechia;Korea, Democratic… |
| Conditions | Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area… |
| Interventions | Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Dec 10, 2016 |
| Target size | 550 |
| Secondary IDs | M15-925 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: