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

Part of paid clinical trials in La Mesa, California.

Sponsor
AbbVie
Study ID
NCT02706873
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo to Upadacitinib — DRUG
    Tablet; Oral
  • Methotrexate — DRUG
    Capsule or Tablet; Oral
  • Placebo to Methotrexate — DRUG
    Capsule or Tablet; Oral
  • Upadacitinib — DRUG
    Tablet; Oral

Study Details

The objectives of Period 1 were the following: * To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; * To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

Key Dates

Start date
Feb 23, 2016
Status verified
Jun 2023
Primary completion
Mar 15, 2018
Completion
Nov 10, 2022

Study Design

Enrollment
1,002 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Methotrexate
    Period 1: Participants will receive placebo to upadacitinib once daily and methotrexate once weekly for 48 weeks. Period 2: Participants will continue on placebo to upadacitinib once daily and methotrexate once weekly until the study is unblinded, after which participants will receive open-label methotrexate up to Week 260.
  • Experimental: Upadacitinib 7.5 mg (Japan-only)
    Period 1: Participants will receive upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 7.5 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 7.5 mg up to Week 260.
  • Experimental: Upadacitinib 15 mg
    Period 1: Participants will receive upadacitinib 15 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 15 mg up to Week 260.
  • Experimental: Upadacitinib 30 mg
    Period 1: Participants will receive upadacitinib 30 mg once daily and placebo to methotrexate once weekly for 48 weeks. Period 2: Participants will continue on upadacitinib 30 mg once daily and placebo to methotrexate once weekly until the study is unblinded, after which participants will receive open-label upadacitinib 30 mg once daily. After implementation of Protocol Amendment 6 participants will receive upadacitinib 15 mg once daily up to Week 260.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 - Global Analysis [ Time Frame: Baseline and Week 12 ]

Locations (32)

FacilityCityStateZIPSite coordinators
TriWest Research Associates- La Mesa /ID# 143738La MesaCalifornia91942-
Desert Medical Advances /ID# 143730Palm DesertCalifornia92260-
International Medical Research - Daytona /ID# 143748Daytona BeachFlorida32117-
FL Med Ctr and Research, Inc. /ID# 143724MiamiFlorida33142-
Millennium Research /ID# 143736Ormond BeachFlorida32174-
Arthritis Research of Florida /ID# 143743Palm HarborFlorida34684-2672-
Sarasota Arthritis Center /ID# 145978SarasotaFlorida34239-
FL Med Clinic, PA /ID# 143744ZephyrhillsFlorida33542-
Deerbrook Medical Associates /ID# 143728Vernon HillsIllinois60061-
Four Rivers Clinical Research /ID# 143741PaducahKentucky42003-
Ocean Rheumatology, PA /ID# 143737Toms RiverNew Jersey08755-
Arthritis Rheumatic Back Disorder /ID# 143733Voorhees TownshipNew Jersey08043-
Trinity Health Med Arts Clinic /ID# 143727MinotNorth Dakota58701-
STAT Research, Inc. /ID# 143750VandaliaOhio45377-9464-
Healthcare Research Consultant /ID# 143747TulsaOklahoma74135-
Advanced Rheumatology & Arthri /ID# 147947WexfordPennsylvania15090-
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653SummervilleSouth Carolina29486-7887-
West Tennessee Research Inst /ID# 143723JacksonTennessee38305-
Dr. Ramesh Gupta /ID# 143732MemphisTennessee38119-
Diagnostic Group Integrated He /ID# 152921BeaumontTexas77701-
Adriana Pop-Moody MD Clinic PA /ID# 147626Corpus ChristiTexas78404-
Doctor's Hosp at Renaissance /ID# 156407EdinburgTexas78539-
MedResearch Inc. /ID# 156409El PasoTexas79935-
Accurate Clinical Research /ID# 143749HoustonTexas77089-
Rheumatic Disease Clin Res Ctr /ID# 151103HoustonTexas77004-
SW Rheumatology Res. LLC /ID# 143745MesquiteTexas75150-
Accurate Clinical Management /ID# 159543San AntonioTexas78229-
NextGen Clinical Trials LLP /ID# 150930San AntonioTexas78229-
Sun Research Institute /ID# 159546San AntonioTexas78215-
Arthritis Clinic of Central TX /ID# 159541San MarcosTexas78666-
Arthritis & Osteoporosis Clinic /ID# 159542WacoTexas76710-
Arthritis Clinic of N. VA, P.C /ID# 143734ArlingtonVirginia22205-

Find similar trials in La Mesa, CA

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By research site
TriWest Research Associates- La Mesa· La Mesa, CADesert Medical Advances· Palm Desert, CAInternational Medical Research - Daytona· Daytona Beach, FLFL Med Ctr and Research, Inc.· Miami, FLMillennium Research· Ormond Beach, FLArthritis Research of Florida· Palm Harbor, FL

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