Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859(NCT00870467))

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163292
First received: July 14, 2010
Last updated: January 2, 2013
Last verified: January 2013

July 14, 2010
January 2, 2013
March 2010
October 2012   (final data collection date for primary outcome measure)
  • Evaluation of adverse event [ Time Frame: at week 52 ] [ Designated as safety issue: Yes ]
    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
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Matrix metalloprotease-3 [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Matrix metalloprotease-3 [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • X-ray findings for hands and feet [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01163292 on ClinicalTrials.gov Archive Site
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Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859(NCT00870467))
Humira 40mg/0.8mL Syringe for Subcutaneous Injection -Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859))

The present survey will be conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in the M06-859 study in patients who have continued treatment with adalimumab for 52 weeks.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The participants will be patients who have continued treatment with adalimumab until the end of the treatment period in the M06-859 study.

Rheumatoid Arthritis
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  • Humira
    Those with an exposure
  • Control (Non-Humira)
    Patients who discontinue adalimumab treatment after completion of the M06-859 study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The participants will be patients who have continued treatment with adalimumab until the end of the treatment period in the M06-859 study.

Exclusion Criteria:

  • Contraindications according to the Package Insert (Patients who have serious infections, Patients who have tuberculosis, Patients with a history of hypersensitivity to any ingredient of Humira, Patients who have demyelinating disease or with a history of demyelinating disease, Patients who have cardiac failure congestive).
  • Patients who use biological agents other than adalimumab after the period of treatment in the M06-859 study will be excluded from the present follow-up study.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01163292
P12-069
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Toshiro Maeda AbbVie GK
AbbVie
January 2013

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