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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AbbVie
Study ID
NCT02049138
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Tablet taken orally
  • Pneumococcal 13-valent conjugate vaccine (PCV-13) — BIOLOGICAL
    Administered by intramuscular injection

Study Details

The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.

Key Dates

Start date
Jan 24, 2014
Status verified
Jun 2022
Primary completion
Jul 29, 2021
Completion
Jul 29, 2021

Study Design

Enrollment
493 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib
    Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). Participants who did not achieve a 20% improvement from RCT Baseline in both Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 6 or Week 12 were up-titrated to 12 mg BID. From January 2017 participants were transitioned to a once-daily (QD) regimen of upadacitinib, either 15 mg QD (participants who were taking 6 mg BID) or 30 mg QD (participants taking 12 mg BID). Starting with Protocol Amendment 5 participants receiving 30 mg QD upadacitinib had the option to decrease the dose to 15 mg QD at the investigator's discretion. A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time [ Time Frame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 ]

Locations (52)

FacilityCityStateZIPSite coordinators
Rheum Assoc of North Alabama /ID# 135926HuntsvilleAlabama35801-
AZ Arthritis and Rheumotology Research, PLLC /ID# 135902PhoenixArizona85032-9306-
AZ Arthritis and Rheumotology Research, PLLC /ID# 135931PhoenixArizona85032-9306-
C.V. Mehta MD, Med Corporation /ID# 124092HemetCalifornia92543-
Moores Cancer Center at UC San Diego /ID# 128747La JollaCalifornia92093-
Desert Medical Advances - Palm Desert /ID# 135911Palm DesertCalifornia92260-
Orrin Troum, M.D. and Medical /ID# 135933Santa MonicaCalifornia90404-
Duplicate_Robin K. Dore MD, Inc /ID# 135906TustinCalifornia92780-
Inland Rheum Clin Trials Inc. /ID# 136716UplandCalifornia91786-
Duplicate_Desert Valley Medical Group /ID# 135932VictorvilleCalifornia92395-
Denver Arthritis Clinic /ID# 135901DenverColorado80230-
New England Research Associates, LLC /ID# 124085BridgeportConnecticut06606-1827-
Arthritis & Rheumatic Disease Specialties /ID# 135910AventuraFlorida33180-
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082Boca RatonFlorida33486-
Omega Research Maitland, LLC /ID# 124094DeBaryFlorida32713-2260-
University of Florida /ID# 124087JacksonvilleFlorida32209-
Suncoast Research Group /ID# 137774MiamiFlorida33135-
Omega Research Maitland, LLC /ID# 137398OrlandoFlorida32808-
Millennium Research /ID# 135917Ormond BeachFlorida32174-
Arthritis Center, Inc. /ID# 124090Palm HarborFlorida34684-
IRIS Research and Development, LLC /ID# 140362PlantationFlorida33324-
Lovelace Scientific Resources /ID# 128745VeniceFlorida34292-
North Georgia Rheumatology Group /ID# 128746LawrencevilleGeorgia30045-
Kansas City Internal Medicine /ID# 135916Overland ParkKansas66209-
PRN Professional Research Network of Kansas, LLC /ID# 124091WichitaKansas67205-
Klein and Associates MD - Hagerstown /ID# 124086HagerstownMaryland21742-
The Center for Rheumatology and Bone Research /ID# 124077WheatonMaryland20902-
Clinical Pharmacology Study Group /ID# 124079WorcesterMassachusetts01605-
June DO, PC /ID# 124081LansingMichigan48910-
Summit Medical Group /ID# 124076CliftonNew Jersey07012-1647-
Arthritis and Osteoporosis Associates /ID# 135907FreeholdNew Jersey07728-8307-
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 135913Voorhees TownshipNew Jersey08043-
Arthritis and Osteo Assoc /ID# 132280Las CrucesNew Mexico88011-
DJL Clinical Research, PLLC /ID# 131936CharlotteNorth Carolina28210-8508-
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 135921CincinnatiOhio45242-4468-
STAT Research, Inc. /ID# 134906VandaliaOhio45377-9464-
Health Research of Oklahoma /ID# 135904Oklahoma CityOklahoma73103-2400-
Duplicate_East Penn Rheumatology Assoc /ID# 135920BethlehemPennsylvania18015-
Altoona Ctr Clinical Res /ID# 124089DuncansvillePennsylvania16635-
Emkey Arthritis and Osteoporosis Clinic /ID# 135908WyomissingPennsylvania19610-
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 124080SummervilleSouth Carolina29486-7887-
Dr. Ramesh Gupta /ID# 128744MemphisTennessee38119-
Austin Rheumatology Research /ID# 124083AustinTexas78705-
Accurate Clinical Management /ID# 128751BaytownTexas77521-
Accurate Clinical Management /ID# 128752HoustonTexas77004-
Accurate Clinical Research /ID# 128753HoustonTexas77089-
Accurate Clinical Research /ID# 128754HoustonTexas77089-
Baylor College of Medicine - Baylor Medical Center /ID# 135905HoustonTexas77030-3411-
Houston Institute for Clin Res /ID# 135912HoustonTexas77074-
SW Rheumatology Res. LLC /ID# 135927MesquiteTexas75150-
Mountain State Clinical Research /ID# 124088ClarksburgWest Virginia26301-
Aurora Rheumatology and Immunotherapy Center /ID# 135922FranklinWisconsin53132-

Find similar trials in Huntsville, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Rheum Assoc of North Alabama· Huntsville, ALAZ Arthritis and Rheumotology Research, PLLC· Phoenix, AZC.V. Mehta MD, Med Corporation· Hemet, CAMoores Cancer Center at UC San Diego· La Jolla, CADesert Medical Advances - Palm Desert· Palm Desert, CAOrrin Troum, M.D. and Medical· Santa Monica, CA

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