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Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

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: NCT00234845
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : August 29, 2007
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE October 10, 2005
Last Update Posted Date August 29, 2007
Study Start Date  ICMJE March 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2005)		 Job loss measurement
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
  • Job productivity measurements
  • Patient reported outcomes
  • DAS28
  • Safety parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
Official Title  ICMJE A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis
Brief Summary The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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  ICMJE Not Provided
Publications * Burmester GR, Landewe 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: October 7, 2005)		 148
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
  • Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
  • Subject must be in paid employment
  • Subject has self-reported work impairment since onset of symptoms

Exclusion Criteria:

  • A subject has chronic arthritis diagnosed before age 16 years.
  • Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
  • Subject has preceding treatment with any biological TNF antagonist
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00234845
Other Study ID Numbers  ICMJE M02-527
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
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