A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)

Sponsor
AbbVie
Study ID
NCT02349451
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment.

Key Dates

Start date
Apr 28, 2015
Status verified
Aug 2017
Primary completion
Jul 4, 2016
Completion
Jul 4, 2016

Study Design

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

Arms

  • Active Comparator: Adalimumab
    Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks
  • Placebo Comparator: Placebo
    Double-blind placebo administered every week (EW) for 12 weeks
  • Experimental: ABT-122 120 mg
    Double-blind ABT-122 120 mg administered EW for 12 weeks
  • Experimental: ABT-122 240 mg
    Double-blind ABT-122 240 mg administered EW for 12 weeks

Primary Outcome Measure

American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo [ Time Frame: Week 12 ]

Related Studies