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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01752855
First received: December 17, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change from baseline in disease activity score (DAS28) [CRP] with baseline being Study M13-390 Week 0 Visit. [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • Response defined by American College of Rheumatology (ACR) 20/50/70/90/100 criteria with baseline being Study M13-390 Week 0 Visit. [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Health assessment Questionnaire (HAQ-DI) with baseline being Study M13-390 Week 0 Visit. [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab
concentration 40mg/0.4 mL
Biological: adalimumab
concentration 40mg/0.4mL
Other Name: Humira

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752855

Locations
United States, Arizona
Site Reference ID/Investigator# 92113
Mesa, Arizona, United States, 85202
United States, California
Site Reference ID/Investigator# 92118
Hemet, California, United States, 92543
United States, Kansas
Site Reference ID/Investigator# 92117
Wichita, Kansas, United States, 67203
United States, New Jersey
Site Reference ID/Investigator# 92115
Clifton, New Jersey, United States, 07012
United States, Pennsylvania
Site Reference ID/Investigator# 92116
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
Site Reference ID/Investigator# 92114
Charleston, South Carolina, United States, 29406
Belgium
Site Reference ID/Investigator# 92053
Brussels, Belgium, 1200
Site Reference ID/Investigator# 92054
Liege, Belgium, 4000
Czech Republic
Site Reference ID/Investigator# 91954
Brno, Czech Republic, 638 00
Site Reference ID/Investigator# 91955
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 91953
Uherske Hradiste, Czech Republic, 686 01
Site Reference ID/Investigator# 91956
Zlin, Czech Republic, 760 01
Germany
Site Reference ID/Investigator# 92073
Ratingen, Germany, 40882
Puerto Rico
Site Reference ID/Investigator# 92074
Vega Baja, Puerto Rico, 00693
Romania
Site Reference ID/Investigator# 92093
Bucharest, Romania, 020475
Site Reference ID/Investigator# 92095
Cluj-Napoca, Romania, 400006
Site Reference ID/Investigator# 92094
Ploiesti, Romania, 100337
Slovakia
Site Reference ID/Investigator# 92096
Banska Bystrica, Slovakia, 97405
Site Reference ID/Investigator# 92097
Senica, Slovakia, 905 01
Site Reference ID/Investigator# 92098
Zilina, Slovakia, 010 01
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Uday Arulmani, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01752855     History of Changes
Other Study ID Numbers: M13-692, 2012-003881-42
Study First Received: December 17, 2012
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014