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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:December 2012
End Date:October 2013
Contact:Melissa Ropiak, BS
Email:melissa.ropiak@abbvie.com
Phone:847-937-0887

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A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab


Phase 2b,open label, multicenter study in rheumatoid arthritis for subjects who completed
the previous M13-390 study.


Inclusion Criteria:

1. Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has
not developed any discontinuation criteria from that study.

2. 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;

3. Subjects must be able and willing to self-administer subcutaneous (SC) injections or
have a qualified person available to administer SC injections.

4. 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.

5. Subjects must be able and willing to provide written informed consent and to comply
with the requirements of this study protocol.

Exclusion Criteria:

1. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days
prior to the Baseline Visit or oral anti-infectives within 14 days prior to the
Baseline Visit.

2. Subject currently uses or plans to use anti-retroviral therapy at any time during the
study.

3. Subject plans to use any live vaccine during the study.

4. Positive pregnancy test at Baseline (Week 0).

5. Subject is considered by the investigator, for any reason, to be an unsuitable
candidate for the study.
We found this trial at
6
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Hemet, CA
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Charleston, South Carolina 29406
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Charleston, SC
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Clifton, NJ
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Mesa, AZ
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Philadelphia, Pennsylvania 19152
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Philadelphia, PA
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Wichita, KS
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