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Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

NCT02433340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2017-07-24

Study results available
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Summary

This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week \[EOW\], 120 mg EOW, or 120 mg every week \[EW\]) or adalimumab 40 mg EOW given on background methotrexate.

Conditions

Interventions

DRUG

ABT-122

Sponsors & Collaborators

Principal Investigators

  • Paul Peloso, MD · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433340 on ClinicalTrials.gov