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Special Investigation in Patients With Rheumatoid Arthritis (Combo Study; Adalimumab With High Dose Methotrexate)

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ClinicalTrials.gov Identifier: NCT01736189
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

November 27, 2012
November 29, 2012
May 10, 2018
September 14, 2012
April 16, 2018   (Final data collection date for primary outcome measure)
  • Disease activity Score 28 [ Time Frame: at week 12 ]
  • Disease activity Score 28 [ Time Frame: at week 52 ]
  • Disease activity Score 28 [ Time Frame: at week 24 ]
  • Disease activity Score 28 [ Time Frame: at week 12 ]
  • Disease activity Score 28 [ Time Frame: at week 24 ]
  • Disease activity Score 28 [ Time Frame: at week 52 ]
Complete list of historical versions of study NCT01736189 on ClinicalTrials.gov Archive Site
  • Simplified disease activity index [ Time Frame: at week 52 ]
  • Health Assessment Questionnaire [ Time Frame: at week 12 ]
  • Health Assessment Questionnaire [ Time Frame: at week 52 ]
  • Simplified disease activity index [ Time Frame: at week 12 ]
  • Health Assessment Questionnaire [ Time Frame: at week 24 ]
  • Simplified disease activity index [ Time Frame: at week 24 ]
  • Clinical disease activity index [ Time Frame: at week 12 ]
  • Number of patients with adverse events [ Time Frame: at week 52 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Clinical disease activity index [ Time Frame: at week 24 ]
  • X-ray findings for hands and feet [ Time Frame: at week 52 ]
  • Clinical disease activity index [ Time Frame: at week 52 ]
  • Clinical disease activity index [ Time Frame: at week 12 ]
  • Clinical disease activity index [ Time Frame: at week 24 ]
  • Clinical disease activity index [ Time Frame: at week 52 ]
  • Simplified disease activity index [ Time Frame: at week 12 ]
  • Simplified disease activity index [ Time Frame: at week 24 ]
  • Simplified disease activity index [ Time Frame: at week 52 ]
  • X-ray findings for hands and feet [ Time Frame: at week 52 ]
  • Health Assessment Questionnaire [ Time Frame: at week 12 ]
  • Health Assessment Questionnaire [ Time Frame: at week 24 ]
  • Health Assessment Questionnaire [ Time Frame: at week 52 ]
  • Number of patients with adverse events [ Time Frame: at week 52 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
Not Provided
Not Provided
 
Special Investigation in Patients With Rheumatoid Arthritis (Combo Study; Adalimumab With High Dose Methotrexate)
Special Investigation in Patients With Rheumatoid Arthritis (Combo Study : Adalimumab With High Dose MTX)
In the usual clinical setting, patients with Rheumatoid Arthritis who receive adalimumab (Humira®) and high-dose Methotrexate (≥12 mg/week) will be investigated prospectively for effectiveness according to Disease Activity Score 28, modified Total Sharp Score, and other measures, as well as safety in terms of the incidence and pattern of occurrence of adverse drug reactions.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Single-arm, Multi-center, Prospective Cohort
Rheumatoid Arthritis
Not Provided
Humira
those with an exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
300
April 16, 2018
April 16, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

The subjects of this study are RA patients and to whom adalimumab is administered. They should be satisfying the following conditions:

  • Disease duration of RA ≤2 years
  • MTX administration ≥3 months
  • Dose of MTX ≥12mg/week
  • DAS28-CRP >3.2

Exclusion Criteria:

  • Patients who have been previously treated with biologics (including TNF inhibitors others)
Sexes Eligible for Study: All
16 Years to 99 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01736189
P13-684
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
May 2018