WHO ICTRP trial
Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately…
EUCTR2016-000570-37-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-000570-37-BE |
|---|---|
| Public title | Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment |
| Scientific title | A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX… |
| Primary sponsor | Gilead Sciences, Inc. |
| 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 | Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea… |
| Conditions | Moderately to severely active rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area… |
| Interventions | Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number… |
| Registration date | Oct 17, 2016 |
| Target size | 1200 |
| Secondary IDs | GS-US-417-0303;2016-000570-37-SK |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: