CLINICAL TRIALS PROFILE FOR UPADACITINIB
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All Clinical Trials for UPADACITINIB
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02049138 ↗ | An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects | Completed | AbbVie | Phase 2 | 2014-01-24 | This is a Phase 2, multicenter, open-label extension study in RA subjects. The sub-study is to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background MTX on immunological responses to Prevnar 13® in RA patients. |
| NCT02066389 ↗ | A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone | Completed | AbbVie | Phase 2 | 2014-03-26 | The primary objective of the study was to compare the safety and efficacy of multiple doses of upadacitinib versus placebo in adults with moderately to severely active rheumatoid arthritis (RA) on stable background methotrexate therapy who had not shown an adequate response to methotrexate alone. |
| NCT02365649 ↗ | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intoleran | Completed | AbbVie | Phase 2 | 2015-03-17 | To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy. |
| NCT02629159 ↗ | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate | Active, not recruiting | AbbVie | Phase 3 | 2015-12-01 | The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX. |
| NCT02675426 ↗ | A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone | Active, not recruiting | AbbVie | Phase 3 | 2015-12-17 | The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs. |
| NCT02706847 ↗ | A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs | Active, not recruiting | AbbVie | Phase 3 | 2016-03-15 | The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of 30 mg once daily (QD) and 15 mg QD upadacitinib versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who were on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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