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Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00235859
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : August 29, 2007
Sponsor:
Collaborator:
Eisai Limited
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE October 7, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date August 29, 2007
Study Start Date  ICMJE July 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2005)
ACR20
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00235859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2005)
Safety parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
Brief Summary The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: adalimumab
  • Drug: methotrexate
Study Arms Not Provided
Publications * Burmester GR, Landewé R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2007)
128
Original Enrollment  ICMJE
 (submitted: October 11, 2005)
120
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9 tender joints
  • Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX
  • Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit
  • Age 18 years and older

Exclusion Criteria:

  • Prior treatment with any TNF antagonist, including adalimumab
  • History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.
  • Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.
  • Chest X-ray with calcified granuloma and/or pleural scarring
  • Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours
  • Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition
  • Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation
  • Female who is pregnant or breast-feeding.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00235859
Other Study ID Numbers  ICMJE M02-556
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Eisai Limited
Investigators  ICMJE
Study Director: Beverly Paperiello Abbott
PRS Account Abbott
Verification Date August 2007

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