A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Sponsor
AbbVie
Study ID
NCT02141997
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    adalimumab administered as subcutaneous injection every other week (EOW)
  • ABT-122 — BIOLOGICAL
    ABT-122 administered as subcutaneous injection every other week (EOW)

Study Details

This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are inadequately responding to methotrexate (MTX) treatment.

Key Dates

Start date
Jul 31, 2014
Status verified
Sep 2016
Primary completion
Sep 30, 2015
Completion
Nov 30, 2015

Study Design

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

Arms

  • Active Comparator: Adalimumab 40 mg EOW
    Adalimumab 40 mg every other week (EOW) for 11 weeks.
  • Experimental: ABT-122 60 mg EOW
    ABT-122 60 mg every other week (EOW) for 11 weeks.
  • Experimental: ABT-122 120 mg EOW
    ABT-122 120 mg every other week (EOW) for 11 weeks.
  • Experimental: ABT-122 120 mg EW
    ABT-122 120 mg every week (EW) for 11 weeks.

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]

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