Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

Part of paid clinical trials in Mesa, Arizona.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01752855
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

Key Dates

Start date
Dec 31, 2012
Status verified
Oct 2014
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
88 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: New formulation of adalimumab 40 mg every other week
    New formulation adalimumab 40 mg every other week

Primary Outcome Measure

Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 [ Time Frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 92113MesaArizona85202-
Site Reference ID/Investigator# 92118HemetCalifornia92543-
Site Reference ID/Investigator# 92117WichitaKansas67203-
Site Reference ID/Investigator# 92115CliftonNew Jersey07012-
Site Reference ID/Investigator# 92116PhiladelphiaPennsylvania19152-
Site Reference ID/Investigator# 92114CharlestonSouth Carolina29406-

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