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

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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 facts

Study ID: NCT01752855
Run by: AbbVie (prior sponsor, Abbott)
People needed: 88
Starts: 2012-12-01
Expected to finish: 2013-10-01
Last updated by the study team: 2014-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
Hormonal contraceptives for 90 days prior to study drug administration;
A vasectomized partner.
Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

You may not qualify if…

Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
Subject plans to use any live vaccine during the study.
Positive pregnancy test at Baseline (Week 0).
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Where it is running

Site Reference ID/Investigator# 92113 — Mesa, Arizona, United States
Site Reference ID/Investigator# 92118 — Hemet, California, United States
Site Reference ID/Investigator# 92117 — Wichita, Kansas, United States
Site Reference ID/Investigator# 92115 — Clifton, New Jersey, United States
Site Reference ID/Investigator# 92116 — Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 92114 — Charleston, South Carolina, United States
Site Reference ID/Investigator# 92053 — Brussels, Belgium
Site Reference ID/Investigator# 92054 — Liège, Belgium
Site Reference ID/Investigator# 91954 — Brno, Czechia
Site Reference ID/Investigator# 91955 — Prague, Czechia
Site Reference ID/Investigator# 91953 — Uherské Hradiště, Czechia
Site Reference ID/Investigator# 91956 — Zlín, Czechia
Site Reference ID/Investigator# 92073 — Ratingen, Germany
Site Reference ID/Investigator# 92074 — Vega Baja, Puerto Rico
Site Reference ID/Investigator# 92093 — Bucharest, Romania
Site Reference ID/Investigator# 92095 — Cluj-Napoca, Romania
Site Reference ID/Investigator# 92094 — Ploieşti, Romania
Site Reference ID/Investigator# 92096 — Banská Bystrica, Slovakia
Site Reference ID/Investigator# 92097 — Senica, Slovakia
Site Reference ID/Investigator# 92098 — Žilina, Slovakia

Full record on ClinicalTrials.gov

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