DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: New formulation adalimumab (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Andy Payne, PhD, Study Director, Affiliation: AbbVie

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48

Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48

Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48

Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48

Secondary outcome: Percentage of Participants Positive for Anti-adalimumab Antibody

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Site Reference ID/Investigator# 92053, Brussels 1200, Belgium

Site Reference ID/Investigator# 92054, Liege 4000, Belgium

Site Reference ID/Investigator# 91954, Brno 638 00, Czech Republic

Site Reference ID/Investigator# 91955, Prague 2 128 50, Czech Republic

Site Reference ID/Investigator# 91953, Uherske Hradiste 686 01, Czech Republic

Site Reference ID/Investigator# 91956, Zlin 760 01, Czech Republic

Site Reference ID/Investigator# 92073, Ratingen 40882, Germany

Site Reference ID/Investigator# 92074, Vega Baja 00693, Puerto Rico

Site Reference ID/Investigator# 92093, Bucharest 020475, Romania

Site Reference ID/Investigator# 92095, Cluj-Napoca 400006, Romania

Site Reference ID/Investigator# 92094, Ploiesti 100337, Romania

Site Reference ID/Investigator# 92096, Banska Bystrica 97405, Slovakia

Site Reference ID/Investigator# 92097, Senica 905 01, Slovakia

Site Reference ID/Investigator# 92098, Zilina 010 01, Slovakia

Site Reference ID/Investigator# 92113, Mesa, Arizona 85202, United States

Site Reference ID/Investigator# 92118, Hemet, California 92543, United States

Site Reference ID/Investigator# 92117, Wichita, Kansas 67203, United States

Site Reference ID/Investigator# 92115, Clifton, New Jersey 07012, United States

Site Reference ID/Investigator# 92116, Philadelphia, Pennsylvania 19152, United States

Site Reference ID/Investigator# 92114, Charleston, South Carolina 29406, United States

Additional Information

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

Starting date: December 2012
Last updated: October 22, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017