Upadacitinib

Generic Name: Upadacitinib

Brand Names: Rinvoq

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₉F_₃N_₆O

CAS Number: 1310726-60-3

Unique Ingredient Identifier: 4RA0KN46E0

Background: Upadacitinib is an oral Janus kinase (JAK)1-selective inhibitor and a disease-modifying antirheumatic drug (DMARD) used in the treatment of rheumatoid arthritis to slow down disease progression. Rheumatoid arthritis is a chronic autoimmune inflammatory disease affecting the peripheral joints. It is characterized by synovial inflammation and hyperplasia, auto...

Indication: Upadacitinib is indicated for the treatment of moderately to severely active rheumatoid arthritis or active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as TNF blockers. In Europe, upadacitinib may be used as monotherapy or in combination with met...

Associated Conditions: Ankylosing Spondylitis (AS), Moderately to Severely Active Rheumatoid Arthritis, Moderately to Severely Active Ulcerative Colitis, Severe Atopic Dermatitis, Active Ankylosing spondylitis, Active Non-radiographic Axial Spondyloarthritis, Active Psoriatic arthritis, Moderate, active Crohn´s Disease, Moderate, refractory Atopic dermatitis, Refractory, severe Atopic Dermatitis, Severe, active Crohn´s Disease

Associated Therapies: -

Clinical Trials

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Phase 2

Completed

Conditions: Ulcerative Colitis (UC)

Interventions: Drug: Placebo
Drug: Upadacitinib

First Posted Date: 2016-06-30

Last Posted Date: 2022-06-30

Lead Sponsor: AbbVie

Target Recruit Count: 1302

Registration Number: NCT02819635

Locations: 🇺🇸
The Vancouver Clinic, INC. PS /ID# 162333, Vancouver, Washington, United States
🇺🇸
East View Medical Research, LLC /ID# 171183, Mobile, Alabama, United States
🇺🇸
CB Flock Research Corporation /ID# 165980, Mobile, Alabama, United States

and more 493 locations

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Upadacitinib

First Posted Date: 2016-03-28

Last Posted Date: 2023-06-07

Lead Sponsor: AbbVie

Target Recruit Count: 197

Registration Number: NCT02720523

Locations: 🇯🇵
Nagoya University Hospital /ID# 148005, Nagoya-shi, Aichi, Japan
🇯🇵
Hamanomachi Hospital /ID# 147991, Fukuoka-shi, Fukuoka, Japan
🇯🇵
Sapporo City General Hospital /ID# 147968, Sapporo, Japan

and more 47 locations

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo to Methotrexate
Drug: Placebo to Upadacitinib
Drug: Methotrexate
Drug: Upadacitinib

First Posted Date: 2016-03-11

Last Posted Date: 2023-07-07

Lead Sponsor: AbbVie

Target Recruit Count: 1002

Registration Number: NCT02706873

Locations: 🇯🇵
Hokkaido University Hospital /ID# 148262, Sapporo, Japan
🇺🇸
TriWest Research Associates- La Mesa /ID# 143738, La Mesa, California, United States
🇺🇸
Desert Medical Advances /ID# 143730, Palm Desert, California, United States

and more 287 locations

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Upadacitinib
Drug: Methotrexate
Drug: Placebo Methotrexate
Drug: Placebo Upadacitinib

First Posted Date: 2016-03-11

Last Posted Date: 2024-01-30

Lead Sponsor: AbbVie

Target Recruit Count: 648

Registration Number: NCT02706951

Locations: 🇺🇸
W. Broward Rheum Assoc Inc. /ID# 146010, Tamarac, Florida, United States
🇺🇸
Sarasota Arthritis Center /ID# 146011, Sarasota, Florida, United States
🇺🇸
University of Arizona Cancer Center - North Campus /ID# 147175, Tucson, Arizona, United States

and more 150 locations

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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Upadacitinib

First Posted Date: 2016-03-11

Last Posted Date: 2023-02-08

Lead Sponsor: AbbVie

Target Recruit Count: 499

Registration Number: NCT02706847

Locations: 🇺🇸
AZ Arthritis and Rheum Assoc /ID# 148593, Mesa, Arizona, United States
🇺🇸
NEA Baptist Clinic /ID# 149280, Jonesboro, Arkansas, United States
🇺🇸
New England Research Associates, LLC /ID# 142763, Bridgeport, Connecticut, United States

and more 185 locations

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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Upadacitinib

First Posted Date: 2016-02-05

Last Posted Date: 2023-04-11

Lead Sponsor: AbbVie

Target Recruit Count: 661

Registration Number: NCT02675426

Locations: 🇪🇸
Hospital Clin Univ San Carlos /ID# 138993, Madrid, Spain
🇺🇸
Houston Institute for Clin Res /ID# 138716, Houston, Texas, United States
🇧🇪
AZ Sint Lucas /ID# 141338, Brugge, Belgium

and more 164 locations

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

Phase 3

Active, not recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: Adalimumab
Drug: Placebo for Adalimumab
Drug: Placebo for Upadacitinib
Drug: Upadacitinib

First Posted Date: 2015-12-14

Last Posted Date: 2024-06-18

Lead Sponsor: AbbVie

Target Recruit Count: 1629

Registration Number: NCT02629159

Locations: 🇺🇸
Precision Research Org, LLC /ID# 143092, Miami Lakes, Florida, United States
🇺🇸
DM Clinical Research /ID# 151357, Tomball, Texas, United States
🇿🇦
Arthritis Clinical Research Tr /ID# 144874, Cape Town, Western Cape, South Africa

and more 367 locations

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

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: Upadacitinib

First Posted Date: 2014-02-19

Last Posted Date: 2021-07-30

Lead Sponsor: AbbVie

Target Recruit Count: 300

Registration Number: NCT02066389

Locations: 🇺🇸
C.V. Mehta MD, Med Corporation /ID# 126380, Hemet, California, United States
🇺🇸
Mountain State Clinical Resear /ID# 127089, Clarksburg, West Virginia, United States
🇿🇦
Panorama Medical Centre /ID# 126846, Cape Town, Western Cape, South Africa

and more 60 locations

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Upadacitinib
Biological: Pneumococcal 13-valent conjugate vaccine (PCV-13)

First Posted Date: 2014-01-30

Last Posted Date: 2022-07-12

Lead Sponsor: AbbVie

Target Recruit Count: 493

Registration Number: NCT02049138

Locations: 🇺🇸
IRIS Research and Development, LLC /ID# 140362, Plantation, Florida, United States
🇨🇱
Quantum Research /ID# 136188, Puerto Varas, Los Lagos, Chile
🇺🇸
The Center for Rheumatology and Bone Research /ID# 124077, Wheaton, Maryland, United States

and more 121 locations

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