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

December 17, 2012
November 4, 2013
December 2012
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01752855 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Biological: adalimumab
concentration 40mg/0.4mL
Other Name: Humira
Experimental: adalimumab
concentration 40mg/0.4 mL
Intervention: Biological: adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Czech Republic,   Germany,   Puerto Rico,   Romania,   Slovakia
 
NCT01752855
M13-692, 2012-003881-42
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Uday Arulmani, MD AbbVie
AbbVie
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP