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

NCT ID: NCT01752855

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-10-31

Brief Summary

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.

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

New formulation of adalimumab 40 mg every other week

New formulation adalimumab 40 mg every other week

Group Type: EXPERIMENTAL

New formulation adalimumab

Intervention Type: BIOLOGICAL

New formulation adalimumab 40 mg every other week

Interventions

New formulation adalimumab

New formulation adalimumab 40 mg every other week

Intervention Type: BIOLOGICAL

Other Intervention Names

Humira

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Payne, PhD

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Countries

United States; Belgium; Czechia; Germany; Puerto Rico; Romania; Slovakia

Related Links

http://rxabbvie.com

This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses.

Other Identifiers

2012-003881-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-692

Identifier Type: -

Identifier Source: org_study_id