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)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AbbVie
Study ID
NCT02706951
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.

Key Dates

Start date
Mar 23, 2016
Status verified
Jan 2024
Primary completion
Oct 2, 2017
Completion
Aug 10, 2022

Study Design

Enrollment
648 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib 30 mg
    Period 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
  • Experimental: Upadacitinib 15 mg
    Period 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
  • Experimental: Methotrexate / Upadacitinib 30 mg
    Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks. Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
  • Experimental: Methotrexate / Upadacitinib 15 mg
    Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks. Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14 [ Time Frame: Baseline and week 14 ]

Locations (52)

FacilityCityStateZIPSite coordinators
Rheum Assoc of North Alabama /ID# 146009HuntsvilleAlabama35801-
Alabama Medical Group, PC /ID# 153941MobileAlabama36608-1787-
ArthroCare Arthritis Care & Re /ID# 143751GilbertArizona85234-
Elite Clinical Studies, LLC /ID# 143760PhoenixArizona85018-
University of Arizona Cancer Center - North Campus /ID# 147175TucsonArizona85719-1478-
NEA Baptist Womens Clinic /ID# 148904JonesboroArkansas72401-
C.V. Mehta MD, Med Corporation /ID# 143762HemetCalifornia92543-
Arthritis Assoc & Osteo Ctr /ID# 147176Colorado SpringsColorado80920-
Ctr Rheum, Immuno, Arthritis /ID# 143766Fort LauderdaleFlorida33309-
South Florida Research Ph I-IV /ID# 151983Miami SpringsFlorida33166-7225-
Advent Clinical Research /ID# 143767Pinellas ParkFlorida33781-
Sarasota Arthritis Center /ID# 146011SarasotaFlorida34239-
W. Broward Rheum Assoc Inc. /ID# 146010TamaracFlorida33321-
BayCare Medical Group, Inc. /ID# 151985TampaFlorida33614-7101-
BayCare Medical Group, Inc. /ID# 163595TampaFlorida33614-7101-
Clinical Research West FL /ID# 148726TampaFlorida33603-
SW FL Clin Res Ctr, Tampa, FL /ID# 143763TampaFlorida33609-
University of South Florida /ID# 146004TampaFlorida33612-
Jefrey D. Lieberman, MD, P.C. /ID# 151816DecaturGeorgia30033-
Great Lakes Clinical Trials /ID# 150935ChicagoIllinois60640-
PRN Professional Research Network of Kansas, LLC /ID# 143761WichitaKansas67205-
Ochsner Clinic Foundation /ID# 153573Baton RougeLouisiana70836-6455-
The Arthritis & Diabetes Clinic, Inc. /ID# 160809MonroeLouisiana71203-
Vanguard Medical Research, LLC /ID# 153124ShreveportLouisiana71011-
Mansfield Health Center /ID# 161627MansfieldMassachusetts02048-
Quality Clinical Research Inc. /ID# 156415OmahaNebraska68114-
Dartmouth-Hitchcock Medical Center /ID# 146008LebanonNew Hampshire03756-
Albuquerque Clinical Trials, Inc /ID# 147618AlbuquerqueNew Mexico87102-
Arthritis and Osteo Assoc /ID# 147177Las CrucesNew Mexico88011-
Coastal Carolina Health Care /ID# 149275New BernNorth Carolina28562-
STAT Research, Inc. /ID# 143770VandaliaOhio45377-9464-
Health Research Oklahoma /ID# 159550Oklahoma CityOklahoma73103-2400-
Healthcare Research Consultant /ID# 147632TulsaOklahoma74135-
Innovative Clinical Research /ID# 143757GreenvilleSouth Carolina29601-
Nashville Arthritis and Rheumatology /ID# 162641NashvilleTennessee37203-
Tekton Research, Inc. /ID# 159554AustinTexas78745-
Diagnostic Group Integrated He /ID# 148725BeaumontTexas77701-
Trinity Universal Res Assoc /ID# 150138CarrolltonTexas75007-
Arth and Osteo Clin Brazo Valley /ID# 160810College StationTexas77845-
Adriana Pop-Moody MD Clinic PA /ID# 147627Corpus ChristiTexas78404-
Accurate Clinical Management /ID# 143768HoustonTexas77004-
Accurate Clinical Research /ID# 143769HoustonTexas77089-
Pioneer Research Solutions, Inc. /ID# 143765HoustonTexas77098-5294-
P&I Clinical Research /ID# 151358LufkinTexas75904-3132-
SW Rheumatology Res. LLC /ID# 147620MesquiteTexas75150-
Sun Research Institute /ID# 159553San AntonioTexas78215-
Arthritis Clinic of Central TX /ID# 149266San MarcosTexas78666-
Adv Rheumatology of Houston /ID# 162609The WoodlandsTexas77382-
DM Clinical Research /ID# 151359TomballTexas77375-
Arthritis & Osteoporosis Clinic /ID# 143752WacoTexas76710-
Ctr for Arth and Rheum Disease /ID# 143759ChesapeakeVirginia23320-
Aurora Rheumatology and Immunotherapy Center /ID# 160811FranklinWisconsin53132-

Find similar trials in Huntsville, AL

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RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Rheum Assoc of North Alabama· Huntsville, ALAlabama Medical Group, PC· Mobile, ALArthroCare Arthritis Care & Re· Gilbert, AZElite Clinical Studies, LLC· Phoenix, AZUniversity of Arizona Cancer Center - North Campus· Tucson, AZNEA Baptist Womens Clinic· Jonesboro, AR

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