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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: New formulation adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01752855

M13-692

2012-003881-42 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. 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.
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

New formulation of adalimumab 40 mg every other week

Experimental group

Description:

New formulation adalimumab 40 mg every other week

Treatment:

Biological: New formulation adalimumab