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

Part of paid clinical trials in Hemet, California.

Sponsor
AbbVie
Study ID
NCT02066389
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Tablets for oral administration
  • Upadacitinib — DRUG
    Tablets for oral administration

Study Details

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.

Key Dates

Start date
Mar 26, 2014
Status verified
Jul 2021
Primary completion
Jul 2, 2015
Completion
Jul 2, 2015

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants received placebo capsules twice daily for 12 weeks.
  • Experimental: Upadacitinib 3 mg BID
    Participants received 3 mg upadacitinib twice daily (BID) for 12 weeks.
  • Experimental: Upadacitinib 6 mg BID
    Participants received 6 mg upadacitinib twice daily (BID) for 12 weeks.
  • Experimental: Upadacitinib 12 mg BID
    Participants received 12 mg upadacitinib twice daily (BID) for 12 weeks.
  • Experimental: Upadacitinib 18 mg BID
    Participants received 18 mg upadacitinib twice daily (BID) for 12 weeks.
  • Experimental: Upadacitinib 24 mg QD
    Participants received 24 mg upadacitinib once daily (QD) for 12 weeks.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (12)

FacilityCityStateZIPSite coordinators
C.V. Mehta MD, Med Corporation /ID# 126380HemetCalifornia92543-
Omega Research Consultants, LLC /ID# 125780DeBaryFlorida32713-2260-
Lovelace Scientific Resources /ID# 127324VeniceFlorida34292-
North Georgia Rheumatology Grp /ID# 125779LawrencevilleGeorgia30045-
PRN Professional Research Network of Kansas, LLC /ID# 126148WichitaKansas67205-
The Center for Rheumatology & /ID# 127323WheatonMaryland20902-
Summit Medical Group /ID# 125776CliftonNew Jersey07012-
Arthritis and Osteo Assoc /ID# 134994Las CrucesNew Mexico88011-
Altoona Ctr Clinical Res /ID# 125777DuncansvillePennsylvania16635-
Emkey Arthritis and Osteo Clin /ID# 134716WyomissingPennsylvania19610-
Accurate Clinical Research /ID# 126535HoustonTexas77034-
Mountain State Clinical Resear /ID# 127089ClarksburgWest Virginia26301-

Find similar trials in Hemet, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
C.V. Mehta MD, Med Corporation· Hemet, CAOmega Research Consultants, LLC· DeBary, FLLovelace Scientific Resources· Venice, FLNorth Georgia Rheumatology Grp· Lawrenceville, GAPRN Professional Research Network of Kansas, LLC· Wichita, KSThe Center for Rheumatology &· Wheaton, MD

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